A Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms (REPLENISH)

April 8, 2019 updated by: TherapeuticsMD

A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus

This study will be a prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter trial of postmenopausal subjects with an intact uterus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postmenopausal subjects with an intact uterus who meet the study entry criteria will be randomized to one of five treatment arms (four active and one placebo) and followed for 12 months. During the Screening period all subjects will be provided with a diary to self-assess the frequency and severity of their vasomotor symptoms. Subjects experiencing a minimum daily frequency of ≥7 (or ≥50 per week) moderate to severe hot flushes will participate in a VMS Substudy during the first 12 weeks of treatment. The Substudy subjects will be stratified by treatment arm within the sites, and only Substudy subjects have the possibility of being randomized to placebo. Subjects who qualify for the study except for experiencing a minimum daily frequency of ≥7 (or ≥50 per week) moderate to severe hot flushes will be stratified within sites to one of the four active treatment arms and followed for 12 months, but will not participate in the VMS Substudy. (However, VMS information will be collected from all subjects during the first 12 weeks of treatment.) All Study Subjects: Postmenopausal women with an intact uterus who seek relief from hot flushes and meet all other inclusion/exclusion criteria are eligible for 12 months of study treatment.

VMS Substudy Subjects: A subset of All Study Subjects who have ≥7 per day or ≥50 per week moderate to severe hot flushes (as determined during Screening) are eligible for the 12-week VMS Substudy and for a total of 12 months of study treatment.

Clinical evaluations will be performed at the following time points:

  • Screening Period (Week: - 8.5) (up to -60 Days)
  • Visit 1 Randomization (Week 0) (Day 1)
  • Visit 2 Interim (Week 4)
  • Visit 3 Interim (Week 8)
  • Visit 4 Interim (Week 12)
  • Visit 5 Interim (Month 6)
  • Visit 6 Interim (Month 9)
  • Visit 7 End of Treatment (Month 12)

Study Type

Interventional

Enrollment (Actual)

1845

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Simon Williamson Clinic
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research
      • Mobile, Alabama, United States, 36608
        • Mobile Ob-Gyn, P.C.
      • Montgomery, Alabama, United States, 36117
        • Montgomery Women's Health
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Advanced Research Associates
      • Mesa, Arizona, United States, 85209
        • Cactus Clinical Research
      • Phoenix, Arizona, United States, 85032
        • Precision Trials
      • Tucson, Arizona, United States, 85712
        • Radiant Research (Tucson)
      • Tucson, Arizona, United States, 85712
        • Visions Clinical Research Tucson
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Health Star Research, LLC
    • California
      • Berkeley, California, United States, 94705
        • Sutter East Bay Medical Foundation
      • La Mesa, California, United States, 91942
        • Grossmont Center for Clinical Research
      • Norwalk, California, United States, 90650
        • Futura Research
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • San Diego, California, United States, 92111
        • Women's Health Care Research Corp.
      • Santa Rosa, California, United States, 95405
        • Radiant Research, Inc.
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80209
        • Downtown Women's Healthcare
      • Denver, Colorado, United States, 80220
        • Horizon's Clinical Research Center
      • Lakewood, Colorado, United States, 80228
        • Red Rocks OB/Gyn
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Clinical Research Consulting
      • New London, Connecticut, United States, 06320
        • Coastal Connecticut Research
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Crystal River, Florida, United States, 34429
        • Nature Coast Clinical Research
      • Fort Myers, Florida, United States, 33916
        • Clinical Physiology Associates
      • Gainesville, Florida, United States, 32607
        • Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
      • Jacksonville, Florida, United States, 32207
        • UF College of Medicine-Jacksonville, Dept. of Obstetrics and Gynecology
      • Margate, Florida, United States, 33063
        • Suncoast Research
      • Melbourne, Florida, United States, 32934
        • Accelovance
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc
      • North Miami, Florida, United States, 33161
        • Segal Institute
      • North Miami Beach, Florida, United States, 33162
        • Ideal Clinical Research
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research (St. Petersburg)
      • Plantation, Florida, United States, 33324
        • All Women's Healthcare of West Broward Discovery Clinical Research
      • West Palm Beach, Florida, United States, 33409
        • Comprehensive Clinical Trials
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Women's Health Associates
      • Atlanta, Georgia, United States, 30328
        • Radiant Research (Atlanta)
      • Decatur, Georgia, United States, 30034
        • Soapstone Center for Clinical Research
      • Sandy Springs, Georgia, United States, 30328
        • Wake Research - Mount Vernon Clinical Research
      • Savannah, Georgia, United States, 31406
        • Fellows Research Alliance
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Illinois
      • Addison, Illinois, United States, 60101
        • Biofortis
      • Champaign, Illinois, United States, 61820
        • Women's Health Practice
      • Chicago, Illinois, United States, 60654
        • Radiant Research (Chicago)
    • Indiana
      • Granger, Indiana, United States, 46530
        • The South Bend Clinic Granger
      • Indianapolis, Indiana, United States, 46250
        • Davis Clinic
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Cypress Medical Research Center, LLC
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Central Kentucky Research Associates
      • Louisville, Kentucky, United States, 40291
        • Bluegrass Clinical Research
    • Louisiana
      • Eunice, Louisiana, United States, 70535
        • Horizon Research Group
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Maryland Center for Sexual Health
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Quest Research Institute
      • Grand Rapids, Michigan, United States, 49503
        • Female Pelvic Medicine & Urogynecology
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
      • Saginaw, Michigan, United States, 48604
        • Saginaw Valley Medical Research Group
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Radiant Research (St. Louis)
    • Montana
      • Billings, Montana, United States, 59102
        • Montana Health
      • Billings, Montana, United States, 59101
        • Billings Clinical Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Women's Clinic of Lincoln
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Affiliated Clinical Research
      • Las Vegas, Nevada, United States, 89113
        • Affiliated Clinical Research INC
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrence OB-GYN Clinical Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc.
      • Albuquerque, New Mexico, United States, 87109
        • Bosque Women's Care
      • Albuquerque, New Mexico, United States, 87109
        • Southwest Clinical Research
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • Port Jefferson, New York, United States, 11777
        • Suffolk OB/GYN
      • Williamsville, New York, United States, 14221
        • Upstate Clinical Research Associates
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • Women's Wellness Clinic
      • High Point, North Carolina, United States, 27262
        • Carolina Medical Trials
      • Raleigh, North Carolina, United States, 27607
        • Centre OBGYN
      • Raleigh, North Carolina, United States, 27612
        • Wake County Research
      • Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Carolina Medical Trials
      • Winston-Salem, North Carolina, United States, 27103
        • Hawthorne Research
      • Winston-Salem, North Carolina, United States, 27103
        • Triad Ob-Gyn
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Lillestol Research
    • Ohio
      • Akron, Ohio, United States, 44311
        • Radiant Research (Akron)
      • Cincinnati, Ohio, United States, 45267-0457
        • University of Cincinnati Physicians Company
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research
      • Columbus, Ohio, United States, 43213
        • Columbus Center for Women's Health Research
      • Englewood, Ohio, United States, 45322
        • HWC Women's Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Oregon
      • Medford, Oregon, United States, 97504
        • Sunstone Medical Research
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center
      • Philadelphia, Pennsylvania, United States, 19114
        • Clinical Research of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15206
        • Clinical Trials Research Services, LLC
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Fellows Research Group
      • Columbia, South Carolina, United States, 29201
        • Vista Clinical Research
      • Greenville, South Carolina, United States, 29615
        • Upstate Pharmaceutical Research
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Medical Research
      • Knoxville, Tennessee, United States, 37920
        • Volunteer Research Group/NOCCR
    • Texas
      • Bryan, Texas, United States, 77802
        • DiscoveResearch, Inc.
      • Corpus Christi, Texas, United States, 78414
        • Advanced Research Associates
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Fort Worth, Texas, United States, 76104
        • Brownstone Clinical Trials
      • Houston, Texas, United States, 77030
        • Advances In Health
      • Houston, Texas, United States, 77054
        • TMC Life Research
      • Houston, Texas, United States, 77054
        • The Women's Hospital of Texas
      • Hurst, Texas, United States, 76054
        • Protenium Clinical Research
      • Irving, Texas, United States, 75062
        • MacArthur OB/GYN
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
      • San Antonio, Texas, United States, 78258
        • Stone Oak, LLC dba Discovery Clinical Trials
      • Schertz, Texas, United States, 78154
        • NECRSA
    • Utah
      • Draper, Utah, United States, 84020
        • PRO/ Salt Lake Women's Center
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research, LLC
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • UVA/Midlife Health at North Ridge
      • Norfolk, Virginia, United States, 23507
        • Clinical Research Center Eastern Virginia Medical School
      • Richmond, Virginia, United States, 23233
        • Virginia Women's Center
      • Richmond, Virginia, United States, 23294
        • National Clinical Research-Richmond, Inc
      • Virginia Beach, Virginia, United States, 23456
        • Tidewater Clinical Research
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Women's Health Research, Gynecology
      • Spokane, Washington, United States, 99027
        • North Spokane Women's Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Be a female between the ages of 40 and 65 years (at the time of randomization) who is willing to participate in the study, as documented by signing the informed consent form.

  2. Be a postmenopausal woman with an intact uterus and a Screening serum estradiol level of ≤50 pg/mL. Postmenopausal is defined herein as:

    1. ≥ 12 months of spontaneous amenorrhea, or
    2. at least 6 months of spontaneous amenorrhea with a Screening serum FSH level of >40 mIU/ml, or
    3. ≥ 6 weeks postsurgical bilateral oophorectomy.
  3. Be seeking treatment or relief for vasomotor symptoms associated with menopause.

  4. To participate in the VMS Substudy, a subject must also report ≥7 moderate to severe hot flushes per day, or ≥50 per week, at the baseline assessment during Screening (subjects whose hot flushes are less frequent may still participate as non-Substudy subjects.

    Note: A minimum of 14 consecutive days of complete hot flush diary data are required during the baseline assessment at Screening, and these consecutive days must occur within the last 14 days prior to the Randomization visit (not counting the Randomization visit day itself). The most recent 7 consecutive days of data prior to randomization (Day -7 to Day -1) will be used to determine the baseline number of mild, moderate and severe hot flushes for each subject.

  5. Have a Body Mass Index (BMI) less than or equal to 34 kg/mP2P. (BMI values should be rounded to the nearest integer [e.g., 34.4 rounds down to 34, while 26.5 rounds up to 27]).
  6. Be willing to abstain from using products (other than study medication) that contain estrogen, progestin, or progesterone throughout study participation.

  7. Be judged by the principal or sub-investigator physician as being in otherwise generally good health based on a medical evaluation performed during the Screening period prior to the initial dose of study medication. The medical evaluation findings must include:

    1. a normal or non-clinically significant physical examination, including vital signs (sitting blood pressure, heart rate, respiratory rate and temperature). Sitting systolic blood pressure is ≤140 mmHg and diastolic blood pressure ≤90 mmHg at Screening. A subject may be taking up to two antihypertensive medications.
    2. a normal or non-clinically significant pelvic examination.
    3. a mammogram that shows no sign of significant disease (can be performed within previous 6 months prior to initial dose of study medication). Subjects must have a BI-RADS 1 or 2 to enroll in the study. An incomplete mammogram result, i.e. BI-RADS 0, is not acceptable. The site must obtain a copy of the official report for the subject's study file, and it must be verified that the mammogram itself is available if needed for additional assessment.
    4. a normal or non-clinically significant clinical breast examination. An acceptable breast examination is defined as no masses or other findings identified that are suspicious of malignancy.
    5. a normal Screening Papanicolaou ("Pap") smear. (Subjects with findings of atypical glandular cells [AGC], AGUS, ASCUS with high risk HPV type upon reflex testing, LSIL, ASC-H, HSIL, dysplastic cells, or malignant cells must be excluded from randomization.)
    6. an acceptable result from an evaluable Screening endometrial biopsy. The endometrial biopsy reports by the two central pathologists at Screening must each specify one of the following: proliferative endometrium; weakly proliferative endometrium; disordered proliferative pattern; secretory endometrium; endometrial tissue other (including benign, inactive or atrophic fragments of endometrial epithelium, glands, stroma, etc); endometrial tissue insufficient for diagnosis; no endometrium identified; or no tissue identified. However, at least one pathologist must identify sufficient tissue to evaluate the biopsy. Additionally, the endometrial biopsy reports by the two central pathologists of Other Findings at Screening must each specify one of the following: endometrial polyp not present; benign endometrial polyp; or polyp other. (See Exclusion criterion #27)
    7. a normal or non-clinically significant 12-lead ECG.

Exclusion Criteria:

  • To participate in the study, a subject must NOT:

    1. Be currently hospitalized.
    2. Have a history of thrombosis of deep veins or arteries or a thromboembolic disorder.
    3. Have a history of coronary artery or cerebrovascular disease (e.g., myocardial infarction, angina, stroke, TIA).
    4. Have a history of a chronic liver or kidney dysfunction/disorder (e.g., Hepatitis C or chronic renal failure).
    5. Have a history of a malabsorption disorder (e.g., gastric bypass, Crohn's disease).
    6. Have a history of gallbladder dysfunction/disorders (e.g., cholangitis, cholecystitis), unless gallbladder has been removed.
    7. Have a history of diabetes, thyroid disease or any other endocrinological disease. (Subjects with diet-controlled diabetes or controlled hypothyroid disease at Screening are not excluded.)
    8. Have a history of estrogen-dependent neoplasia.
    9. Have a history of atypical ductal hyperplasia of the breast.
    10. Have a finding of clinically significant uterine fibroids at Screening.
    11. Have had a uterine ablation.
    12. Have a history of undiagnosed vaginal bleeding.
    13. Have any history of endometrial hyperplasia, melanoma, or uterine/endometrial, breast or ovarian cancer.
    14. Have any history of other malignancy within the last 5 years, with the exception of basal cell (excluded if within 1 year) or non-invasive squamous cell (excluded if within 1 year) carcinoma of the skin.
    15. Have a history of any other cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological (e.g., bipolar disorder, schizophrenia, major depressive disorder), or musculoskeletal disease or disorder that is clinically significant in the opinion of the Principal Investigator or Medical Sub-Investigator.

    16. Have any of the following clinical laboratory values at Screening:

      1. fasting triglyceride of ≥300 mg/dL and/or total cholesterol of ≥300mg/dL
      2. positive laboratory finding for Factor V Leiden mutation
      3. AST or ALT ≥1.5 times the upper limit of normal (ULN)
      4. fasting glucose >125 mg/dL
    17. Be known to be pregnant or have a positive urine pregnancy test. (Note: A pregnancy test is not required for subjects who have had bilateral tubal ligation, bilateral oophorectomy, or are 55 years old or greater and have experienced cessation of menses for at least 1 year.)
    18. Have contraindication to estrogen and/or progestin therapy or allergy to the use of estradiol and/or progesterone or any components of the investigational drugs.
    19. Use 15 or more cigarettes per day or currently use any electronic cigarettes.
    20. Have a history of drug and/or alcohol abuse within one year of start of study.
    21. Have used, within 28 days prior to the initial dose of study medication at Visit 1, any medication known to induce or inhibit CYP3A4 enzyme activity that may affect estrogen and/or progestin drug metabolism. (See 48TUSection 4.3U48T)
    22. Have used, within 28 days prior to Screening, or plan to use during the study, any prescription or over-the-counter (OTC) medications (including herbal products, such as St. John's Wort) that would be expected to alter progesterone or estrogen activity or is being used to treat vasomotor symptoms. (See Section 4.3U48T)

    23. Have used estrogen alone or estrogen/progestin, SERM (selective estrogen receptor modulator), testosterone, or estrogen/testosterone for any of the following time periods:

      1. Vaginal nonsystemic hormonal products (rings, creams, gels) within 7 days prior to Screening, or vaginal systemic products (e.g., FemRing) within 28 days prior to Screening.
      2. Transdermal estrogen alone or estrogen/progestin products within 8 weeks prior to Screening.
      3. Oral estrogen and/or progestin and/or SERM therapy within 8 weeks prior to Screening.
      4. Progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months prior to Screening.
      5. Estrogen pellet therapy or progestational injectable drug therapy within 6 months prior to Screening.
      6. Percutaneous estrogen lotions/gels within 8 weeks prior to Screening.
      7. Oral, topical, vaginal, patch, implantable or injectable androgen therapy within 8 weeks prior to Screening.
    24. Have used an intrauterine device (IUD) within the 12 weeks prior to Screening.
    25. For subjects in the VMS Substudy only: use of medication that may affect the outcome of the vasomotor symptom endpoints within 28 days prior to Screening (e.g. SSRIs [selective serotonin reuptake inhibitors], SNRIs [serotonin and norepinephrine reuptake inhibitors], aldomet, dopaminergic or antidopaminergic drugs, gabapentin, clonidine, or bellergal.)
    26. Have any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the subject from safely participating in the study or complying with protocol requirements.
    27. Have a Screening endometrial biopsy sample that is found by both primary pathologists to have endometrial tissue insufficient for diagnosis, no endometrium identified, or no tissue identified. (With the approval of the Medical Monitor, the Screening endometrial biopsy may be repeated once.)
    28. Endometrial polyps with atypical nuclei reported by at least 1 central pathologist.
    29. Have contraindication to any planned study assessments (e.g., endometrial biopsy).
    30. Have participated in another clinical trial within 30 days prior to Screening, have received an investigational drug within the three months prior to the initial dose of study medication, or be likely to participate in a clinical trial or receive another investigational medication during the study.
    31. Currently use marijuana.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment 1
Combined Estradiol 1 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.
Drug: Placebo
Drug: Progesterone
Other Names:
  • Prometrium
Drug: Estradiol
Other Names:
  • Estrace
  • 17B-estradiol
Experimental: Treatment 2
Combined Estradiol 0.5 mg / Progesterone 100 mg softgel capsule formulation and placebo taken orally once a day for twelve months.
Drug: Placebo
Drug: Progesterone
Other Names:
  • Prometrium
Drug: Estradiol
Other Names:
  • Estrace
  • 17B-estradiol
Experimental: Treatment 3
Combined Estradiol 0.5 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.
Drug: Placebo
Drug: Progesterone
Other Names:
  • Prometrium
Drug: Estradiol
Other Names:
  • Estrace
  • 17B-estradiol
Experimental: Treatment 4
Combined Estradiol 0.25 mg / Progesterone 50 mg softgel capsule formulation and placebo, taken orally once a day for twelve months.
Drug: Placebo
Drug: Progesterone
Other Names:
  • Prometrium
Drug: Estradiol
Other Names:
  • Estrace
  • 17B-estradiol
Placebo Comparator: Placebo
Two Placebo softgel capsules taken orally once a day for twelve months.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
Time Frame: Baseline and Week 4
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 4
Co-Primary Efficacy Endpoint: Frequency of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
Time Frame: Baseline and Week 12
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 12
Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
Time Frame: Baseline and Week 4
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 4
Co-Primary Efficacy Endpoint: Severity of Moderate to Severe Vasomotor Symptoms (MITT-VMS)
Time Frame: Baseline and Week 12
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 12
Primary Safety Endpoint: Endometrial Protection - Hyperplasia
Time Frame: Baseline and Month 12
Endometrial biopsies centrally evaluated by 2 primary pathologists using criteria from Blaustein's Pathology text. Pathologists classified bx into 1 of following 3 categories: Cat.1: Non-endometrial malignancy/non-hyperplasia; Cat.2: Endometrial hyperplasia; Cat.3: Endometrial malignancy. Consensus reached when 2 primary pathologist agreed on any of above categories; if primary pathologists disagreed on presence of hyperplasia, result of 3rd pathologist was utilized and final decision regarding presence of hyperplasia was based on diagnosis of majority. If all 3 reads disparate, final diagnosis based on most severe dx. Incidence rate calculated as: I=A/B where I=incidence rate at M12 evaluation, A=all new subjects with biopsies positive for endometrial hyperplasia during study but post-Baseline, B=all subjects w/biopsies following M11 meeting criteria specified plus all subjects w/biopsies positive for endometrial hyperplasia by any pathologists before M11.
Baseline and Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial Protection - Hyperplasia
Time Frame: Baseline and Month 12
Endometrial biopsies centrally evaluated by 3 primary pathologists using criteria described in Blaustein's Pathology text. Pathologists classified biopsy into 1 of following 3 categories: Cat.1: Non-endometrial malignancy/non-hyperplasia; Cat.2: Endometrial hyperplasia; Cat.3: Endometrial malignancy. Consensus was reached when the 2 of 3 pathologist readers agreed on any of the above categories; if all three reads were disparate, the final diagnosis was based on the most severe diagnosis. Incidence rate calculated as: I=A/B where I=incidence rate at M12 evaluation, A=all new subjects with biopsies positive for endometrial hyperplasia during study but post-Baseline, B=all subjects with biopsies following M11 meeting the criteria specified plus all subjects with biopsies positive for endometrial hyperplasia by any of the pathologists before M11.
Baseline and Month 12
Frequency of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)
Time Frame: Baseline and Week 1
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 1
Frequency of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)
Time Frame: Baseline and Week 2
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 2
Frequency of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)
Time Frame: Baseline and Week 3
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 3
Frequency of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)
Time Frame: Baseline and Week 4
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 4
Frequency of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)
Time Frame: Baseline and Week 5
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 5
Frequency of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)
Time Frame: Baseline and Week 6
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 6
Frequency of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)
Time Frame: Baseline and Week 7
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 7
Frequency of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)
Time Frame: Baseline and Week 8
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 8
Frequency of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)
Time Frame: Baseline and Week 9
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 9
Frequency of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)
Time Frame: Baseline and Week 10
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 10
Frequency of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)
Time Frame: Baseline and Week 11
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 11
Frequency of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week.
Baseline and Week 12
Severity of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)
Time Frame: Baseline and Week 1
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 1
Severity of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)
Time Frame: Baseline and Week 2
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 2
Severity of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)
Time Frame: Baseline and Week 3
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 3
Severity of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)
Time Frame: Baseline and Week 4
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 4
Severity of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)
Time Frame: Baseline and Week 5
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 5
Severity of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)
Time Frame: Baseline and Week 6
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 6
Severity of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)
Time Frame: Baseline and Week 7
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 7
Severity of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)
Time Frame: Baseline and Week 8
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 8
Severity of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)
Time Frame: Baseline and Week 9
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 9
Severity of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)
Time Frame: Baseline and Week 10
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 10
Severity of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)
Time Frame: Baseline and Week 11
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 11
Severity of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 12
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 (MITT-VMS)
Time Frame: Baseline and Week 1
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 1
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 (MITT-VMS)
Time Frame: Baseline and Week 2
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 2
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 (MITT-VMS)
Time Frame: Baseline and Week 3
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 3
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 (MITT-VMS)
Time Frame: Baseline and Week 4
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 4
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 (MITT-VMS)
Time Frame: Baseline and Week 5
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 5
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 (MITT-VMS)
Time Frame: Baseline and Week 6
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 6
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 (MITT-VMS)
Time Frame: Baseline and Week 7
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 7
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 (MITT-VMS)
Time Frame: Baseline and Week 8
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 8
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 (MITT-VMS)
Time Frame: Baseline and Week 9
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 9
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 (MITT-VMS)
Time Frame: Baseline and Week 10
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 10
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 (MITT-VMS)
Time Frame: Baseline and Week 11
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 11
Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week.
Baseline and Week 12
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 (MITT-VMS)
Time Frame: Baseline and Week 1
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 1
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 (MITT-VMS)
Time Frame: Baseline and Week 2
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 2
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 (MITT-VMS)
Time Frame: Baseline and Week 3
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 3
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 (MITT-VMS)
Time Frame: Baseline and Week 4
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 4
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 (MITT-VMS)
Time Frame: Baseline and Week 5
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 5
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 (MITT-VMS)
Time Frame: Baseline and Week 6
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 6
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 (MITT-VMS)
Time Frame: Baseline and Week 7
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 7
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 (MITT-VMS)
Time Frame: Baseline and Week 8
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 8
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 (MITT-VMS)
Time Frame: Baseline and Week 9
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 9
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 (MITT-VMS)
Time Frame: Baseline and Week 10
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 10
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 (MITT-VMS)
Time Frame: Baseline and Week 11
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 11
Severity of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days).
Baseline and Week 12
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 1 (MITT-VMS)
Time Frame: Baseline and Week 1
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe VMS from Baseline to Week 1.
Baseline and Week 1
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 2 (MITT-VMS)
Time Frame: Baseline and Week 2
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 2.
Baseline and Week 2
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 3 (MITT-VMS)
Time Frame: Baseline and Week 3
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 3.
Baseline and Week 3
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 4 (MITT-VMS)
Time Frame: Baseline and Week 4
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4.
Baseline and Week 4
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 5 (MITT-VMS)
Time Frame: Baseline and Week 5
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 5.
Baseline and Week 5
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 6 (MITT-VMS)
Time Frame: Baseline and Week 6
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 6.
Baseline and Week 6
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 7 (MITT-VMS)
Time Frame: Baseline and Week 7
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 7.
Baseline and Week 7
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 8 (MITT-VMS)
Time Frame: Baseline and Week 8
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8.
Baseline and Week 8
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 9 (MITT-VMS)
Time Frame: Baseline and Week 9
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 9.
Baseline and Week 9
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 10 (MITT-VMS)
Time Frame: Baseline and Week 10
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 10.
Baseline and Week 10
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 11 (MITT-VMS)
Time Frame: Baseline and Week 11
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 11.
Baseline and Week 11
Reduction of Frequency of Moderate to Severe Vasomotor Symptoms - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12.
Baseline and Week 12
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 1 - (MITT-VMS)
Time Frame: Baseline and Week 1
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 1.
Baseline and Week 1
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 2 - (MITT-VMS)
Time Frame: Baseline and Week 2
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 2.
Baseline and Week 2
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 3 - (MITT-VMS)
Time Frame: Baseline and Week 3
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 3.
Baseline and Week 3
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 4 - (MITT-VMS)
Time Frame: Baseline and Week 4
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 4.
Baseline and Week 4
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 5 - (MITT-VMS)
Time Frame: Baseline and Week 5
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 5.
Baseline and Week 5
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 6 - (MITT-VMS)
Time Frame: Baseline and Week 6
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 6.
Baseline and Week 6
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 7 - (MITT-VMS)
Time Frame: Baseline and Week 7
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 7.
Baseline and Week 7
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 8 - (MITT-VMS)
Time Frame: Baseline and Week 8
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 8.
Baseline and Week 8
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 9 - (MITT-VMS)
Time Frame: Baseline and Week 9
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 9.
Baseline and Week 9
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 10 - (MITT-VMS)
Time Frame: Baseline and Week 10
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 10.
Baseline and Week 10
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 11 - (MITT-VMS)
Time Frame: Baseline and Week 11
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 11.
Baseline and Week 11
Reduction of Frequency of Mild, Moderate and Severe Vasomotor Symptoms - Week 12 - (MITT-VMS)
Time Frame: Baseline and Week 12
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 12.
Baseline and Week 12
Clinical Global Impression (CGI) - Week 4 (MITT-VMS)
Time Frame: Baseline and Week 4
The number and percentage of subjects for each possible response to the CGI at Week 4. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.
Baseline and Week 4
Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 4 (MITT-VMS)
Time Frame: Baseline and Week 4
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.
Baseline and Week 4
Clinical Global Impression (CGI) - Week 8 (MITT-VMS)
Time Frame: Baseline and Week 8
The number and percentage of subjects for each possible response to the CGI at Week 8. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.
Baseline and Week 8
Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 8 (MITT-VMS)
Time Frame: Baseline and Week 8
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.
Baseline and Week 8
Clinical Global Impression (CGI) - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
The number and percentage of subjects for each possible response to the CGI at Week 12. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.
Baseline and Week 12
Mean Change in Frequency of Moderate to Severe VMS for the Respective CGI Category - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo.
Baseline and Week 12
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 1 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 1 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 2 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 2 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 3 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 3 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 4 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 4 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 5 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 5 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 6 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 6 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 7 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 7 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 8 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 8 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 9 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 9 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 10 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 10 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 11 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 11 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: Cycle 12 to 13
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
Cycle 12 to 13
Number of Subjects Without Bleeding for Consecutive Cycles
Time Frame: The 13th Cycle
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time.
The 13th Cycle
Number of Subjects With Cumulative Amenorrhea From Cycle 1 to 13
Time Frame: Cycle 1 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 1 to 13 was calculated and compared between active and placebo treatments.
Cycle 1 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 2 to 13
Time Frame: Cycle 2 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 2 to 13 was calculated and compared between active and placebo treatments.
Cycle 2 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 3 to 13
Time Frame: Cycle 3 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 3 to 13 was calculated and compared between active and placebo treatments.
Cycle 3 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 4 to 13
Time Frame: Cycle 4 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 4 to 13 was calculated and compared between active and placebo treatments.
Cycle 4 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 5 to 13
Time Frame: Cycle 5 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 5 to 13 was calculated and compared between active and placebo treatments.
Cycle 5 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 6 to 13
Time Frame: Cycle 6 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 6 to 13 was calculated and compared between active and placebo treatments.
Cycle 6 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 7 to 13
Time Frame: Cycle 7 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 7 to 13 was calculated and compared between active and placebo treatments.
Cycle 7 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 8 to 13
Time Frame: Cycle 8 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 8 to 13 was calculated and compared between active and placebo treatments.
Cycle 8 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 9 to 13
Time Frame: Cycle 9 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 9 to 13 was calculated and compared between active and placebo treatments.
Cycle 9 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 10 to 13
Time Frame: Cycle 10 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 10 to 13 was calculated and compared between active and placebo treatments.
Cycle 10 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 11 to 13
Time Frame: Cycle 11 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 11 to 13 was calculated and compared between active and placebo treatments.
Cycle 11 to 13
Number of Subjects With Cumulative Amenorrhea From Cycle 12 to 13
Time Frame: Cycle 12 to 13
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 12 to 13 was calculated and compared between active and placebo treatments.
Cycle 12 to 13
Number of Subjects With Cumulative Amenorrhea From the 13th Cycle
Time Frame: The 13th Cycle
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from the 13th Cycle was calculated and compared between active and placebo treatments.
The 13th Cycle
Subject Incidence With Spotting - Trimester 1 (Safety Pop.)
Time Frame: Trimester 1
Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 1
Subject Incidence With Spotting - Trimester 2 (Safety Pop.)
Time Frame: Trimester 2
Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 2
Subject Incidence With Spotting - Trimester 3 (Safety Pop.)
Time Frame: Trimester 3
Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 3
Subject Incidence With Spotting - Trimester 4 (Safety Pop.)
Time Frame: Trimester 4
Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 4
Number of Days With Spotting - Trimester 1 (Safety Pop.)
Time Frame: Trimester 1
Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 1
Number of Days With Spotting - Trimester 2 (Safety Pop.)
Time Frame: Trimester 2
Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 2
Number of Days With Spotting - Trimester 3 (Safety Pop.)
Time Frame: Trimester 3
Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 3
Number of Days With Spotting - Trimester 4 (Safety Pop.)
Time Frame: Trimester 4
Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 4
Subject Incidence With Bleeding - Trimester 1 (Safety Pop.)
Time Frame: Trimester 1
Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 1
Subject Incidence With Bleeding - Trimester 2 (Safety Pop.)
Time Frame: Trimester 2
Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 2
Subject Incidence With Bleeding - Trimester 3 (Safety Pop.)
Time Frame: Trimester 3
Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 3
Subject Incidence With Bleeding - Trimester 4 (Safety Pop.)
Time Frame: Trimester 4
Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 4
Number of Days With Bleeding - Trimester 1 (Safety Pop.)
Time Frame: Trimester 1
Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 1
Number of Days With Bleeding - Trimester 2 (Safety Pop.)
Time Frame: Trimester 2
Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 2
Number of Days With Bleeding - Trimester 3 (Safety Pop.)
Time Frame: Trimester 3
Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 3
Number of Days With Bleeding - Trimester 4 (Safety Pop.)
Time Frame: Trimester 4
Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1.
Trimester 4
Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Changes in Vasomotor Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 6 (MITT-VMS)
Time Frame: Baseline and Month 6
Changes in Vasomotor Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 12 (MITT-VMS)
Time Frame: Baseline and Month 12
Changes in Vasomotor Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Changes in Psychosocial Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 6 (MITT-VMS)
Time Frame: Baseline and Month 6
Changes in Psychosocial Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 12 (MITT-VMS)
Time Frame: Baseline and Month 12
Changes in Psychosocial Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Changes in Physical Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 6 (MITT-VMS)
Time Frame: Baseline and Month 6
Changes in Physical Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 12 (MITT-VMS)
Time Frame: Baseline and Month 12
Changes in Physical Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Changes in Sexual Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 6 (MITT-VMS)
Time Frame: Baseline and Month 6
Changes in Sexual Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 12 (MITT-VMS)
Time Frame: Baseline and Month 12
Changes in Sexual Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Changes in Overall Scores from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 6 (MITT-VMS)
Time Frame: Baseline and Month 6
Changes in Overall Scores from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 12 (MITT-VMS)
Time Frame: Baseline and Month 12
Changes in Overall Scores from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 6 (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 12 (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Week 12 (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 6 - (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 12 - (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Week 12 - (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 6 - (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 12 - (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Week 12 - (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 6 - (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 12 - (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Week 12 - (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 6 - (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 12 - (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Week 12 - (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 6 - (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 12 - (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Week 12 - (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 6 - (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 12 - (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Week 12 - (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 6 - (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 12 - (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Optimal Sleep - Week 12 - (MITT-VMS)
Time Frame: Baseline and Week 12
Change from Baseline (BL) to Week 12 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 6 - (MITT-VMS)
Time Frame: Baseline and Month 6
Change from Baseline (BL) to Month 6 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 12 - (MITT-VMS)
Time Frame: Baseline and Month 12
Change from Baseline (BL) to Month 12 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Week 12 (MITT)
Time Frame: Baseline and Week 12
Changes in Vasomotor Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 6 (MITT)
Time Frame: Baseline and Month 6
Changes in Vasomotor Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Vasomotor Domain Score - Month 12 (MITT)
Time Frame: Baseline and Month 12
Changes in Vasomotor Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Week 12 (MITT)
Time Frame: Baseline and Week 12
Changes in Psychosocial Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 6 (MITT)
Time Frame: Baseline and Month 6
Changes in Psychosocial Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Psychosocial Domain Score - Month 12 (MITT)
Time Frame: Baseline and Month 12
Changes in Psychosocial Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Week 12 (MITT)
Time Frame: Baseline and Week 12
Changes in Physical Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 6 (MITT)
Time Frame: Baseline and Month 6
Changes in Physical Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Physical Domain Score - Month 12 (MITT)
Time Frame: Baseline and Month 12
Changes in Physical Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Week 12 (MITT)
Time Frame: Baseline and Week 12
Changes in Sexual Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 6 (MITT)
Time Frame: Baseline and Month 6
Changes in Sexual Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Sexual Domain Score - Month 12 (MITT)
Time Frame: Baseline and Month 12
Changes in Sexual Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Week 12 (MITT)
Time Frame: Baseline and Week 12
Change in Overall Scores from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Week 12
Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 6 (MITT)
Time Frame: Baseline and Month 6
Change in Overall Scores from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 6
Menopause-specific Quality of Life Questionnaire (MENQOL) - Overall Scores - Month 12 (MITT)
Time Frame: Baseline and Month 12
Change in Overall Scores from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being "not at all bothered" and 8 being "extremely bothered".
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Week 12 (MITT)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 6 (MITT)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Sleep Scale - Total Sleep Score - Month 12 (MITT)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Week 12 - (MITT)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 6 - (MITT)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Disturbance - Month 12 - (MITT)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Week 12 - (MITT)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 6 - (MITT)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Snoring - Month 12 - (MITT)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Week 12 - (MITT)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 6 - (MITT)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Short of Breath or Headache - Month 12 - (MITT)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Week 12 - (MITT)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 6 - (MITT)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Adequacy - Month 12 - (MITT)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Week 12 - (MITT)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 6 - (MITT)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Somnolence - Month 12 - (MITT)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0="best possible" & 100="worst possible". MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Week 12 - (MITT)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 6 - (MITT)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index I - Month 12 - (MITT)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Week 12 - (MITT)
Time Frame: Baseline and Week 12
Change from Baseline to Wk 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Sleep Problems Index II - Month 6 - (MITT)
Time Frame: Baseline and Month 6
Change from Baseline to Month 6 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Individual Score for Sleep Problems Index II - Month 12 - (MITT)
Time Frame: Baseline and Month 12
Change from Baseline to Month 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0="best possible" & 100="worst possible" as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome.
Baseline and Month 12
Medical Outcomes Sleep Study (MOS) Optimal Sleep - Week 12 - (MITT)
Time Frame: Baseline and Week 12
Change from Baseline (BL) to Wk 12 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.
Baseline and Week 12
Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 6 - (MITT)
Time Frame: Baseline and Month 6
Change from Baseline (BL) to Month 6 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.
Baseline and Month 6
Medical Outcomes Sleep Study (MOS) Optimal Sleep - Month 12 - (MITT)
Time Frame: Baseline and Month 12
Change from Baseline (BL) to Month 12 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm.
Baseline and Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TherapeuticsMD

Investigators

  • Study Director: Sebastian Mirkin, MD, TherapeuticsMD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2013

Primary Completion (Actual)

October 28, 2016

Study Completion (Actual)

October 28, 2016

Study Registration Dates

First Submitted

September 5, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2019

Last Update Submitted That Met QC Criteria

April 8, 2019

Last Verified

April 1, 2019

More Information

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Other Study ID Numbers

  • TXC12-05
  • REPLENISH Trial (Other Identifier: Sponsor)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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