Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes
- Conditions
- Hot Flushes, Menopause, Postmenopause
- Interventions
- Registration Number
- NCT00160342
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1251
- Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
- Be a female of any race between the ages of 45-65 years, in generally good health,
- Be either naturally or surgically postmenopausal (with or without a uterus)
- Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 Esterified Estrogens (EE) and Methyltestosterone (MT) - 7 Esterified Estrogens (EE) and Methyltestosterone (MT) - 8 Esterified Estrogens (EE) and Methyltestosterone (MT) - 9 Esterified Estrogens (EE) and Methyltestosterone (MT) - 1 Esterified Estrogens (EE) and Methyltestosterone (MT) - 2 Esterified Estrogens (EE) and Methyltestosterone (MT) - 3 Esterified Estrogens (EE) and Methyltestosterone (MT) - 4 Esterified Estrogens (EE) and Methyltestosterone (MT) - 5 Esterified Estrogens (EE) and Methyltestosterone (MT) -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (125)
Site 42
🇺🇸Virginia Beach, Virginia, United States
Site 14
🇺🇸Waterbury, Connecticut, United States
Site 4
🇺🇸Groton, Connecticut, United States
Site 52
🇺🇸Baton Rouge, Louisiana, United States
Site 73
🇺🇸Metarie, Louisiana, United States
Site 65
🇺🇸Mandeville, Louisiana, United States
Site 28
🇺🇸Reno, Nevada, United States
Site 24
🇺🇸Greenville, South Carolina, United States
Site 10
🇺🇸Chattanooga, Tennessee, United States
Site 100
🇨🇦North Vancouver, British Columbia, Canada
Site 112
🇨🇦Montreal, Quebec, Canada
Site 103
🇨🇦Rimouski, Quebec, Canada
Site 119
🇨🇦Sainte Foy, Quebec, Canada
Site 91
🇨🇦Shawinigan, Quebec, Canada
Site 94
🇨🇦Sainte Foy, Quebec, Canada
Site 136
🇨🇦Sherbrooke, Quebec, Canada
Site 124
🇷🇺Moscow, Russian Federation
Site 133
🇷🇺Moscow, Russian Federation
Site 125
🇷🇺Moscow, Russian Federation
Site 128
🇷🇺Moscow, Russian Federation
Site 129
🇷🇺Moscow, Russian Federation
Site 130
🇷🇺Moscow, Russian Federation
Site 74
🇺🇸Chicago, Illinois, United States
Site 11
🇺🇸Houston, Texas, United States
Site 5
🇺🇸Seattle, Washington, United States
Site 27
🇺🇸San Diego, California, United States
Site 54
🇺🇸San Diego, California, United States
Site 81
🇺🇸Cincinnati, Ohio, United States
Site 93
🇨🇦Winnipeg, Manitoba, Canada
Site 122
🇨🇦Winnipeg, Manitoba, Canada
Site 56
🇺🇸Nashville, Tennessee, United States
Site 30
🇺🇸San Antonio, Texas, United States
Site 49
🇺🇸Salt Lake City, Utah, United States
Site 66
🇺🇸Denver, Colorado, United States
Site 89
🇺🇸Portland, Oregon, United States
Site 50
🇺🇸Evansville, Indiana, United States
Site 36
🇺🇸Lincoln, Nebraska, United States
Site 18
🇺🇸San Diego, California, United States
Site 69
🇺🇸Montgomery, Alabama, United States
Site 37
🇺🇸Montgomery, Alabama, United States
Site 31
🇺🇸Vista, California, United States
Site 58
🇺🇸Chicago, Illinois, United States
Site 40
🇺🇸Alpharetta, Georgia, United States
Site 68
🇺🇸Walnut Creek, California, United States
Site 51
🇺🇸Clearwater, Florida, United States
Site 21
🇺🇸Stuart, Florida, United States
Site 71
🇺🇸Clearwater, Florida, United States
Site 35
🇺🇸New Britain, Connecticut, United States
Site 53
🇺🇸Columbus, Ohio, United States
Site 41
🇺🇸San Antonio, Texas, United States
Site 34
🇺🇸Mayfield Heights, Ohio, United States
Site 79
🇺🇸Raleigh, North Carolina, United States
Site 19
🇺🇸Kansas City, Missouri, United States
Site 77
🇺🇸Tulsa, Oklahoma, United States
Site 80
🇺🇸Chesterfield, Missouri, United States
Site 86
🇺🇸Bryan, Texas, United States
Site 82
🇺🇸Tampa, Florida, United States
Site 9
🇺🇸Venice, Florida, United States
Site 43
🇺🇸Ann Arbor, Michigan, United States
Site 15
🇺🇸Lutherville, Maryland, United States
Site 13
🇺🇸Portland, Oregon, United States
Site 2
🇺🇸Norfolk, Virginia, United States
Site 17
🇺🇸Billings, Montana, United States
Site 39
🇺🇸New Bern, North Carolina, United States
Site 46
🇺🇸Winston Salem, North Carolina, United States
Site 84
🇺🇸Philadelphia, Pennsylvania, United States
Site 59
🇺🇸Winston Salem, North Carolina, United States
Site 63
🇺🇸Pottstown, Pennsylvania, United States
Site 120
🇨🇦Abbotsford, British Columbia, Canada
Site 29
🇺🇸Richmond, Virginia, United States
Site 22
🇺🇸Warwick, Rhode Island, United States
Site 135
🇨🇦Victoria, British Columbia, Canada
Site 92
🇨🇦Sarnia, Ontario, Canada
Site 137
🇨🇦Ottawa, Ontario, Canada
Site 109
🇨🇦Burlington, Ontario, Canada
Site 116
🇨🇦West Vancouver, British Columbia, Canada
Site 114
🇨🇦Corunna, Ontario, Canada
Site 115
🇨🇦Kingston, Ontario, Canada
Site 107
🇨🇦London, Ontario, Canada
Site 106
🇨🇦Newmarket, Ontario, Canada
Site 95
🇨🇦Hamilton, Ontario, Canada
Site 96
🇨🇦Strathroy, Ontario, Canada
Site 127
🇷🇺St. Petersburg, Russian Federation
Site 131
🇷🇺St. Petersburg, Russian Federation
Site 132
🇷🇺Moscow, Russian Federation
Site 134
🇷🇺St. Petersburg, Russian Federation
Site 138
🇷🇺St. Petersburg, Russian Federation
Site 76
🇺🇸Boise, Idaho, United States
Site 85
🇺🇸Carmichael, California, United States
Site 72
🇺🇸Chicago, Illinois, United States
Site 61
🇺🇸Daytona Beach, Florida, United States
Site 64
🇺🇸Champaign, Illinois, United States
Site 20
🇺🇸Corpus Christi, Texas, United States
Site 23
🇺🇸Atlanta, Georgia, United States
Site 8
🇺🇸Atlanta, Georgia, United States
Site 12
🇺🇸Chaska, Minnesota, United States
Site 45
🇺🇸Cincinnati, Ohio, United States
Site 44
🇺🇸Tucson, Arizona, United States
Site 62
🇺🇸Little Rock, Arkansas, United States
Site 6
🇺🇸Jonesboro, Arkansas, United States
Site 87
🇺🇸Northridge, California, United States
Site 70
🇺🇸Carmichael, California, United States
Site 25
🇺🇸Aventura, Florida, United States
Site 26
🇺🇸Aventura, Florida, United States
Site 75
🇺🇸Gainesville, Florida, United States
Site 33
🇺🇸Pensacola, Florida, United States
Site 60
🇺🇸Powder Springs, Georgia, United States
Site 90
🇺🇸Alpharetta, Georgia, United States
Site 83
🇺🇸West Palm Beach, Florida, United States
Site 55
🇺🇸Savannah, Georgia, United States
Site 7
🇺🇸Las Vegas, Nevada, United States
Site 16
🇺🇸Kansas City, Missouri, United States
Site 3
🇺🇸St. Louis, Missouri, United States
Site 78
🇺🇸Mogadore, Ohio, United States
Site 67
🇺🇸Hilton Head, South Carolina, United States
Site 38
🇺🇸Spokane, Washington, United States
Site 47
🇺🇸Charlottesville, Virginia, United States
Site 111
🇨🇦St. John's, Newfoundland and Labrador, Canada
Site 32
🇺🇸Tacoma, Washington, United States
Site 117
🇨🇦Peterborough, Ontario, Canada
Site 113
🇨🇦Sarnia, Ontario, Canada
Site 105
🇨🇦Sherbrooke, Quebec, Canada
Site 126
🇷🇺Moscow, Russian Federation
Site 48
🇺🇸Richmond, Virginia, United States
Site 88
🇺🇸Memphis, Tennessee, United States