Study Evaluating The Effects Of Bazedoxifene/Conjugated Estrogens On Endometrial Safety And Postmenopausal Osteoporosis

March 10, 2014 updated by: Pfizer

A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women

The purpose of this research study is to evaluate the safety and effectiveness of this investigational drug for the treatment of menopausal symptoms while protecting the endometrium (uterine lining) and preventing postmenopausal osteoporosis. Subject participation will last approximately 14.5 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1886

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

  • Argentina
      • Buenos Aires, Argentina, C1117ABH
        • Pfizer Investigational Site
      • Buenos Aires, Argentina, C1128AAF
        • Pfizer Investigational Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1012AAR
        • Pfizer Investigational Site
      • Caba, Buenos Aires, Argentina, C1425AGC
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Pfizer Investigational Site
      • St Leonards, New South Wales, Australia, 2065
        • Pfizer Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Pfizer Investigational Site
  • Chile
    • RM
      • Santiago, RM, Chile, 8320152
        • Pfizer Investigational Site
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia
        • Pfizer Investigational Site
    • Atlantico
      • Barranquilla, Atlantico, Colombia
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Pfizer Investigational Site
      • Ballerup, Denmark, 2750
        • Pfizer Investigational Site
      • Vejle, Denmark, 7100
        • Pfizer Investigational Site
  • Finland
      • Kuopio, Finland, 70110
        • Pfizer Investigational Site
      • Oulu, Finland, 90 100
        • Pfizer Investigational Site
  • Hungary
      • Bekescsaba, Hungary, H-5600
        • Pfizer Investigational Site
      • Budapest, Hungary, 1106
        • Pfizer Investigational Site
      • Budapest, Hungary, H-1125
        • Pfizer Investigational Site
      • Debrecen, Hungary, H-4012
        • Pfizer Investigational Site
      • Debrecen, Hungary, H-4043
        • Pfizer Investigational Site
      • Kecskemet, Hungary, 6000
        • Pfizer Investigational Site
      • Nyiregyhaza, Hungary, H-4400
        • Pfizer Investigational Site
      • Tatabanya, Hungary, H-2800
        • Pfizer Investigational Site
  • Mexico
      • D.F, Mexico
        • Pfizer Investigational Site
  • New Zealand
      • Christchurch, New Zealand, 8014
        • Pfizer Investigational Site
    • NZ
      • Dunedin, NZ, New Zealand
        • Pfizer Investigational Site
      • Wellington, NZ, New Zealand
        • Pfizer Investigational Site
  • Norway
      • Alesund, Norway, NO-6003
        • Pfizer Investigational Site
      • Hamar, Norway, NO-2317
        • Pfizer Investigational Site
  • Poland
      • Lublin, Poland, 20-090
        • Pfizer Investigational Site
      • Poznan, Poland, 60-535
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-341
        • Pfizer Investigational Site
      • Warszawa, Poland, 01-809
        • Pfizer Investigational Site
      • Wroclaw, Poland, 50-088
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Pfizer Investigational Site
      • Glendale, Arizona, United States, 85308
        • Pfizer Investigational Site
      • Mesa, Arizona, United States, 85206
        • Pfizer Investigational Site
      • Peoria, Arizona, United States, 85381
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85032
        • Pfizer Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85715
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85712
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85710
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • Pfizer Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95821
        • Pfizer Investigational Site
      • San Diego, California, United States, 92108
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • Upland, California, United States, 91786
        • Pfizer Investigational Site
      • Vista, California, United States, 92083
        • Pfizer Investigational Site
      • Walnut Creek, California, United States, 94598
        • Pfizer Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Pfizer Investigational Site
      • Colorado Springs, Colorado, United States, 80910
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80220
        • Pfizer Investigational Site
      • Denver, Colorado, United States, 80218
        • Pfizer Investigational Site
      • Lakewood, Colorado, United States, 80228
        • Pfizer Investigational Site
    • Connecticut
      • New London, Connecticut, United States, 06320
        • Pfizer Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Pfizer Investigational Site
      • Clearwater, Florida, United States, 33759
        • Pfizer Investigational Site
      • Crystal River, Florida, United States, 34429
        • Pfizer Investigational Site
      • Daytona Beach, Florida, United States, 32114
        • Pfizer Investigational Site
      • Deland, Florida, United States, 32720
        • Pfizer Investigational Site
      • Ft. Lauderdale, Florida, United States, 33316
        • Pfizer Investigational Site
      • Ft. Lauderdale, Florida, United States, 33328
        • Pfizer Investigational Site
      • Ft. Myers, Florida, United States, 33916
        • Pfizer Investigational Site
      • Lake Worth, Florida, United States, 33461
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33169
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Miami Springs, Florida, United States, 33166
        • Pfizer Investigational Site
      • New Port Richey, Florida, United States, 34652
        • Pfizer Investigational Site
      • Pinellas Park, Florida, United States, 33781
        • Pfizer Investigational Site
      • Sunrise, Florida, United States, 33323
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33606
        • Pfizer Investigational Site
      • Vero Beach, Florida, United States, 32960
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Augusta, Georgia, United States, 30909
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30319
        • Pfizer Investigational Site
      • Savannah, Georgia, United States, 31405
        • Pfizer Investigational Site
      • Savannah, Georgia, United States, 31406
        • Pfizer Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Pfizer Investigational Site
      • Idaho Falls, Idaho, United States, 83404
        • Pfizer Investigational Site
      • Meridian, Idaho, United States, 83642
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pfizer Investigational Site
      • Rockford, Illinois, United States, 61107
        • Pfizer Investigational Site
    • Indiana
      • South Bend, Indiana, United States, 46601
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • Pfizer Investigational Site
      • Lousiville, Kentucky, United States, 40291
        • Pfizer Investigational Site
    • Maine
      • Bangor, Maine, United States, 4401
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, United States, 49009
        • Pfizer Investigational Site
      • Paw Paw, Michigan, United States, 49079
        • Pfizer Investigational Site
      • Saginaw, Michigan, United States, 48604
        • Pfizer Investigational Site
      • Southfield, Michigan, United States, 48034
        • Pfizer Investigational Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Pfizer Investigational Site
      • Chaska, Minnesota, United States, 55318
        • Pfizer Investigational Site
      • Robbinsdale, Minnesota, United States, 55422
        • Pfizer Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63131
        • Pfizer Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • Pfizer Investigational Site
      • Billings, Montana, United States, 59102
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68131
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89146
        • Pfizer Investigational Site
      • North Las Vegas, Nevada, United States, 89030
        • Pfizer Investigational Site
      • Reno, Nevada, United States, 89502
        • Pfizer Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Pfizer Investigational Site
    • New Jersey
      • Brick, New Jersey, United States, 08723
        • Pfizer Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
      • Albuquerque, New Mexico, United States, 87106
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • Port Jefferson, New York, United States, 11777
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 29209
        • Pfizer Investigational Site
      • Kernersville, North Carolina, United States, 27284
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Pfizer Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Pfizer Investigational Site
      • Fargo, North Dakota, United States, 58103
        • Pfizer Investigational Site
      • Minot, North Dakota, United States, 58701
        • Pfizer Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44311
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44122
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44106-6010
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43213
        • Pfizer Investigational Site
      • Dayton, Ohio, United States, 45439
        • Pfizer Investigational Site
      • Englewood, Ohio, United States, 45322
        • Pfizer Investigational Site
      • Mayfield Heights, Ohio, United States, 44124
        • Pfizer Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pfizer Investigational Site
      • Medford, Oregon, United States, 97504
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97205
        • Pfizer Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16502
        • Pfizer Investigational Site
      • Hopwood, Pennsylvania, United States, 15445
        • Pfizer Investigational Site
      • Jenkintown, Pennsylvania, United States, 19046
        • Pfizer Investigational Site
      • Johnstown, Pennsylvania, United States, 15905
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19114
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Pfizer Investigational Site
      • West Reading, Pennsylvania, United States, 19611
        • Pfizer Investigational Site
      • Wexford, Pennsylvania, United States, 15090
        • Pfizer Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Pfizer Investigational Site
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Pfizer Investigational Site
      • Greer, South Carolina, United States, 29651
        • Pfizer Investigational Site
      • Hilton Head Island, South Carolina, United States, 29926
        • Pfizer Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Pfizer Investigational Site
      • Sioux Falls, South Dakota, United States, 57104
        • Pfizer Investigational Site
      • Sioux Falls, South Dakota, United States, 67105
        • Pfizer Investigational Site
      • Watertown, South Dakota, United States, 57201
        • Pfizer Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Pfizer Investigational Site
      • Jackson, Tennessee, United States, 38305
        • Pfizer Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • Pfizer Investigational Site
      • Memphis, Tennessee, United States, 38120
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78414
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75390
        • Pfizer Investigational Site
      • Denton, Texas, United States, 76210
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76104
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Irving, Texas, United States, 75062
        • Pfizer Investigational Site
      • Irving, Texas, United States, 75061
        • Pfizer Investigational Site
      • Plano, Texas, United States, 75093
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78154
        • Pfizer Investigational Site
      • Waco, Texas, United States, 76712
        • Pfizer Investigational Site
    • Utah
      • Pleasant Grove, Utah, United States, 84062
        • Pfizer Investigational Site
      • Salt Lake City, Utah, United States, 84117
        • Pfizer Investigational Site
      • Sandy, Utah, United States, 84070
        • Pfizer Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States, 23502
        • Pfizer Investigational Site
      • Norfolk, Virginia, United States, 23507
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Pfizer Investigational Site
      • Tacoma, Washington, United States, 98405
        • Pfizer Investigational Site

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Generally healthy, postmenopausal women, aged 40 to 64 seeking treatment for menopausal symptoms
  • At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels > 40 mIU/mL
  • Intact Uterus

Exclusion Criteria:

  • Use of oral estrogen, progestin, androgen, or selective estrogen receptor modulator (SERM) containing drug products within 8 weeks before screening
  • A history or active presence of clinically important medical disease: eg. cardiovascular disease (stroke, heart attack), chronic renal or liver disease, breast cancer, etc.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 5
Placebo
Drug: Placebo
One capsule, placebo (over-encapsulated), once a day for one year.
Experimental: 1
bazedoxifene 20 mg/conjugated estrogens 0.45 mg
Drug: bazedoxifene 20 mg/ conjugated estrogens 0.45 mg
One capsule, bazedoxifene 20 mg/conjugated estrogens 0.45 mg (over-encapsulated), once a day for one year.
Experimental: 2
bazedoxifene 20 mg/conjugated estrogens 0.625 mg
Drug: bazedoxifene 20 mg/ conjugated estrogens 0.625 mg
One capsule, bazedoxifene 20 mg/conjugated estrogens 0.625 mg (over-encapsulated), once a day for one year.
Experimental: 3
bazedoxifene 20 mg
Drug: bazedoxifene 20 mg
One capsule, bazedoxifene 20 mg (over-encapsulated), once a day for one year.
Active Comparator: 4
Prempro
Drug: conjugated estrogens 0.45 mg/ medroxyprogesterone acetate 1.5 mg
One capsule, conjugated estrogens 0.45 mg and medroxyprogesterone 1.5 mg (over-encapsulated), once a day for one year.
Other Names:
  • Prempro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
Time Frame: Month 12
Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis.
Month 12
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study
Time Frame: Baseline, Month 12
BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
Baseline, Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study
Time Frame: Baseline, Month 6
BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
Baseline, Month 6
Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study
Time Frame: Baseline, Month 6, Month 12
BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported.
Baseline, Month 6, Month 12
Percentage of Participants With Cumulative Amenorrhea: Main Study
Time Frame: Day 1 up to Day 364
Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study.
Day 1 up to Day 364
Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study
Time Frame: Baseline, Month 12
Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study
Baseline, Month 12
Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study
Time Frame: Baseline, Month 6, 12
Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels.
Baseline, Month 6, 12
Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study
Time Frame: Baseline
Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.
Baseline
Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study
Time Frame: Baseline, Month 3
Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment.
Baseline, Month 3
Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study
Time Frame: Baseline
MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.
Baseline
Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study
Time Frame: Baseline, Month 3
MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms.
Baseline, Month 3
Percentage of Participants With Uterine Bleeding
Time Frame: Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52
Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy.
Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Breast Tenderness
Time Frame: Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52
Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated.
Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52

Collaborators and Investigators

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

Sponsor

Pfizer

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

Helpful Links

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

January 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

December 12, 2008

First Submitted That Met QC Criteria

December 12, 2008

First Posted (Estimate)

December 15, 2008

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

March 10, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3115A1-3307
  • B2311009

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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