Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes

A Multi-Center, Double-Blind, Placebo-Controlled Comparison of Multiple Doses of Esterified Estrogens and Methyltestosterone, in Combination and Alone, in Relieving Vasomotor Symptoms in Postmenopausal Women

This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women

Study Overview

• Status: Completed
• Conditions: Hot Flushes, Menopause, Postmenopause
• Intervention / Treatment: Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); Drug: Esterified Estrogens (EE) and Methyltestosterone (MT)

• Study Type: Interventional
• Enrollment (Anticipated): 1251
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Abbotsford, British Columbia, Canada
      • Site 120
    • North Vancouver, British Columbia, Canada
      • Site 100
    • Victoria, British Columbia, Canada
      • Site 135
    • West Vancouver, British Columbia, Canada
      • Site 116
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • Site 122
    • Winnipeg, Manitoba, Canada
      • Site 93
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada
      • Site 111
  • Ontario
    • Burlington, Ontario, Canada
      • Site 109
    • Corunna, Ontario, Canada
      • Site 114
    • Hamilton, Ontario, Canada
      • Site 95
    • Kingston, Ontario, Canada
      • Site 115
    • London, Ontario, Canada
      • Site 107
    • Newmarket, Ontario, Canada
      • Site 106
    • Ottawa, Ontario, Canada
      • Site 137
    • Peterborough, Ontario, Canada
      • Site 117
    • Sarnia, Ontario, Canada
      • Site 113
    • Sarnia, Ontario, Canada
      • Site 92
    • Strathroy, Ontario, Canada
      • Site 96
  • Quebec
    • Montreal, Quebec, Canada
      • Site 112
    • Rimouski, Quebec, Canada
      • Site 103
    • Sainte Foy, Quebec, Canada
      • Site 119
    • Sainte Foy, Quebec, Canada
      • Site 94
    • Shawinigan, Quebec, Canada
      • Site 91
    • Sherbrooke, Quebec, Canada
      • Site 105
    • Sherbrooke, Quebec, Canada
      • Site 136
• Russian Federation
  • Moscow, Russian Federation
    • Site 124
  • Moscow, Russian Federation
    • Site 125
  • Moscow, Russian Federation
    • Site 126
  • Moscow, Russian Federation
    • Site 128
  • Moscow, Russian Federation
    • Site 129
  • Moscow, Russian Federation
    • Site 130
  • Moscow, Russian Federation
    • Site 132
  • Moscow, Russian Federation
    • Site 133
  • St. Petersburg, Russian Federation
    • Site 127
  • St. Petersburg, Russian Federation
    • Site 131
  • St. Petersburg, Russian Federation
    • Site 134
  • St. Petersburg, Russian Federation
    • Site 138
• United States
  • Alabama
    • Montgomery, Alabama, United States
      • Site 37
    • Montgomery, Alabama, United States
      • Site 69
  • Arizona
    • Tucson, Arizona, United States
      • Site 44
  • Arkansas
    • Jonesboro, Arkansas, United States
      • Site 6
    • Little Rock, Arkansas, United States
      • Site 62
  • California
    • Carmichael, California, United States
      • Site 70
    • Carmichael, California, United States
      • Site 85
    • Northridge, California, United States
      • Site 87
    • San Diego, California, United States
      • Site 18
    • San Diego, California, United States
      • Site 27
    • San Diego, California, United States
      • Site 54
    • Vista, California, United States
      • Site 31
    • Walnut Creek, California, United States
      • Site 68
  • Colorado
    • Denver, Colorado, United States
      • Site 66
  • Connecticut
    • Groton, Connecticut, United States
      • Site 4
    • New Britain, Connecticut, United States
      • Site 35
    • Waterbury, Connecticut, United States
      • Site 14
  • Florida
    • Aventura, Florida, United States
      • Site 25
    • Aventura, Florida, United States
      • Site 26
    • Clearwater, Florida, United States
      • Site 51
    • Clearwater, Florida, United States
      • Site 71
    • Daytona Beach, Florida, United States
      • Site 61
    • Gainesville, Florida, United States
      • Site 75
    • Pensacola, Florida, United States
      • Site 33
    • Stuart, Florida, United States
      • Site 21
    • Tampa, Florida, United States
      • Site 82
    • Venice, Florida, United States
      • Site 9
    • West Palm Beach, Florida, United States
      • Site 83
  • Georgia
    • Alpharetta, Georgia, United States
      • Site 40
    • Alpharetta, Georgia, United States
      • Site 90
    • Atlanta, Georgia, United States
      • Site 23
    • Atlanta, Georgia, United States
      • Site 8
    • Powder Springs, Georgia, United States
      • Site 60
    • Savannah, Georgia, United States
      • Site 55
  • Idaho
    • Boise, Idaho, United States
      • Site 76
  • Illinois
    • Champaign, Illinois, United States
      • Site 64
    • Chicago, Illinois, United States
      • Site 58
    • Chicago, Illinois, United States
      • Site 72
    • Chicago, Illinois, United States
      • Site 74
  • Indiana
    • Evansville, Indiana, United States
      • Site 50
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • Site 52
    • Mandeville, Louisiana, United States
      • Site 65
    • Metarie, Louisiana, United States
      • Site 73
  • Maryland
    • Lutherville, Maryland, United States
      • Site 15
  • Michigan
    • Ann Arbor, Michigan, United States
      • Site 43
  • Minnesota
    • Chaska, Minnesota, United States
      • Site 12
  • Missouri
    • Chesterfield, Missouri, United States
      • Site 80
    • Kansas City, Missouri, United States
      • Site 16
    • Kansas City, Missouri, United States
      • Site 19
    • St. Louis, Missouri, United States
      • Site 3
  • Montana
    • Billings, Montana, United States
      • Site 17
  • Nebraska
    • Lincoln, Nebraska, United States
      • Site 36
  • Nevada
    • Las Vegas, Nevada, United States
      • Site 7
    • Reno, Nevada, United States
      • Site 28
  • North Carolina
    • New Bern, North Carolina, United States
      • Site 39
    • Raleigh, North Carolina, United States
      • Site 79
    • Winston Salem, North Carolina, United States
      • Site 46
    • Winston Salem, North Carolina, United States
      • Site 59
  • Ohio
    • Cincinnati, Ohio, United States
      • Site 45
    • Cincinnati, Ohio, United States
      • Site 81
    • Columbus, Ohio, United States
      • Site 53
    • Mayfield Heights, Ohio, United States
      • Site 34
    • Mogadore, Ohio, United States
      • Site 78
  • Oklahoma
    • Tulsa, Oklahoma, United States
      • Site 77
  • Oregon
    • Portland, Oregon, United States
      • Site 13
    • Portland, Oregon, United States
      • Site 89
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Site 84
    • Pottstown, Pennsylvania, United States
      • Site 63
  • Rhode Island
    • Warwick, Rhode Island, United States
      • Site 22
  • South Carolina
    • Greenville, South Carolina, United States
      • Site 24
    • Hilton Head, South Carolina, United States
      • Site 67
  • Tennessee
    • Chattanooga, Tennessee, United States
      • Site 10
    • Memphis, Tennessee, United States
      • Site 88
    • Nashville, Tennessee, United States
      • Site 56
  • Texas
    • Bryan, Texas, United States
      • Site 86
    • Corpus Christi, Texas, United States
      • Site 20
    • Houston, Texas, United States
      • Site 11
    • San Antonio, Texas, United States
      • Site 30
    • San Antonio, Texas, United States
      • Site 41
  • Utah
    • Salt Lake City, Utah, United States
      • Site 49
  • Virginia
    • Charlottesville, Virginia, United States
      • Site 47
    • Norfolk, Virginia, United States
      • Site 2
    • Richmond, Virginia, United States
      • Site 29
    • Richmond, Virginia, United States
      • Site 48
    • Virginia Beach, Virginia, United States
      • Site 42
  • Washington
    • Seattle, Washington, United States
      • Site 5
    • Spokane, Washington, United States
      • Site 38
    • Tacoma, Washington, United States
      • Site 32

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
2. Be a female of any race between the ages of 45-65 years, in generally good health,
3. Be either naturally or surgically postmenopausal (with or without a uterus)

Exclusion Criteria:

1. Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
2. History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo
Experimental: 3	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo
Active Comparator: 1	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo
Experimental: 5	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo
Active Comparator: 4	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo
Experimental: 6	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo
Active Comparator: 7	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo
Active Comparator: 8	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo
Placebo Comparator: 9	Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.45 EE; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, 0.60 MT; Drug: Esterified Estrogens (EE) and Methyltestosterone (MT); oral tablet, QD, 12 weeks, Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4	4 weeks
Mean change in frequency of moderate to severe VMS from baseline to Week 12	12 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 4	4 weeks
Mean change in severity of moderate to severe VMS from baseline to Week 12	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency and severity of moderate to severe and all hot flushes at each week	12 weeks
Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome	12 weeks
Mean change from baseline to Week 12 in vaginal pH	12 weeks
Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells)	12 weeks

Collaborators and Investigators

• Sponsor: Solvay Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Estimate): August 15, 2008
• Last Update Submitted That Met QC Criteria: August 14, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Hormone replacement therapy, hot flushes, postmenopause
• Additional Relevant MeSH Terms: Hot Flashes; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Estrogens; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate; Estrogens, Esterified (USP); Estrone
• Other Study ID Numbers: S030.2.112; 2005-002887-27