Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes
NCT ID: NCT00160342
Last Updated: 2008-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1251 participants
INTERVENTIONAL
2005-06-30
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
2
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
3
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
4
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE
5
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
6
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
7
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.45 EE
8
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.60 MT
9
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, Placebo
Interventions
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Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.15 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.15 EE/0.30 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE/0.30 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.30 EE/0.60 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.45 EE
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, 0.60 MT
Esterified Estrogens (EE) and Methyltestosterone (MT)
oral tablet, QD, 12 weeks, Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
45 Years
65 Years
FEMALE
No
Sponsors
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Solvay Pharmaceuticals
INDUSTRY
Responsible Party
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Solvay Pharmaceuticals
Principal Investigators
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Global Clinical Director Solvay
Role: STUDY_DIRECTOR
Solvay Pharmaceuticals
Locations
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Site 37
Montgomery, Alabama, United States
Site 69
Montgomery, Alabama, United States
Site 44
Tucson, Arizona, United States
Site 6
Jonesboro, Arkansas, United States
Site 62
Little Rock, Arkansas, United States
Site 70
Carmichael, California, United States
Site 85
Carmichael, California, United States
Site 87
Northridge, California, United States
Site 18
San Diego, California, United States
Site 27
San Diego, California, United States
Site 54
San Diego, California, United States
Site 31
Vista, California, United States
Site 68
Walnut Creek, California, United States
Site 66
Denver, Colorado, United States
Site 4
Groton, Connecticut, United States
Site 35
New Britain, Connecticut, United States
Site 14
Waterbury, Connecticut, United States
Site 25
Aventura, Florida, United States
Site 26
Aventura, Florida, United States
Site 51
Clearwater, Florida, United States
Site 71
Clearwater, Florida, United States
Site 61
Daytona Beach, Florida, United States
Site 75
Gainesville, Florida, United States
Site 33
Pensacola, Florida, United States
Site 21
Stuart, Florida, United States
Site 82
Tampa, Florida, United States
Site 9
Venice, Florida, United States
Site 83
West Palm Beach, Florida, United States
Site 40
Alpharetta, Georgia, United States
Site 90
Alpharetta, Georgia, United States
Site 23
Atlanta, Georgia, United States
Site 8
Atlanta, Georgia, United States
Site 60
Powder Springs, Georgia, United States
Site 55
Savannah, Georgia, United States
Site 76
Boise, Idaho, United States
Site 64
Champaign, Illinois, United States
Site 58
Chicago, Illinois, United States
Site 72
Chicago, Illinois, United States
Site 74
Chicago, Illinois, United States
Site 50
Evansville, Indiana, United States
Site 52
Baton Rouge, Louisiana, United States
Site 65
Mandeville, Louisiana, United States
Site 73
Metarie, Louisiana, United States
Site 15
Lutherville, Maryland, United States
Site 43
Ann Arbor, Michigan, United States
Site 12
Chaska, Minnesota, United States
Site 80
Chesterfield, Missouri, United States
Site 16
Kansas City, Missouri, United States
Site 19
Kansas City, Missouri, United States
Site 3
St Louis, Missouri, United States
Site 17
Billings, Montana, United States
Site 36
Lincoln, Nebraska, United States
Site 7
Las Vegas, Nevada, United States
Site 28
Reno, Nevada, United States
Site 39
New Bern, North Carolina, United States
Site 79
Raleigh, North Carolina, United States
Site 46
Winston-Salem, North Carolina, United States
Site 59
Winston-Salem, North Carolina, United States
Site 45
Cincinnati, Ohio, United States
Site 81
Cincinnati, Ohio, United States
Site 53
Columbus, Ohio, United States
Site 34
Mayfield Heights, Ohio, United States
Site 78
Mogadore, Ohio, United States
Site 77
Tulsa, Oklahoma, United States
Site 13
Portland, Oregon, United States
Site 89
Portland, Oregon, United States
Site 84
Philadelphia, Pennsylvania, United States
Site 63
Pottstown, Pennsylvania, United States
Site 22
Warwick, Rhode Island, United States
Site 24
Greenville, South Carolina, United States
Site 67
Hilton Head, South Carolina, United States
Site 10
Chattanooga, Tennessee, United States
Site 88
Memphis, Tennessee, United States
Site 56
Nashville, Tennessee, United States
Site 86
Bryan, Texas, United States
Site 20
Corpus Christi, Texas, United States
Site 11
Houston, Texas, United States
Site 30
San Antonio, Texas, United States
Site 41
San Antonio, Texas, United States
Site 49
Salt Lake City, Utah, United States
Site 47
Charlottesville, Virginia, United States
Site 2
Norfolk, Virginia, United States
Site 29
Richmond, Virginia, United States
Site 48
Richmond, Virginia, United States
Site 42
Virginia Beach, Virginia, United States
Site 5
Seattle, Washington, United States
Site 38
Spokane, Washington, United States
Site 32
Tacoma, Washington, United States
Site 120
Abbotsford, British Columbia, Canada
Site 100
North Vancouver, British Columbia, Canada
Site 135
Victoria, British Columbia, Canada
Site 116
West Vancouver, British Columbia, Canada
Site 122
Winnipeg, Manitoba, Canada
Site 93
Winnipeg, Manitoba, Canada
Site 111
St. John's, Newfoundland and Labrador, Canada
Site 109
Burlington, Ontario, Canada
Site 114
Corunna, Ontario, Canada
Site 95
Hamilton, Ontario, Canada
Site 115
Kingston, Ontario, Canada
Site 107
London, Ontario, Canada
Site 106
Newmarket, Ontario, Canada
Site 137
Ottawa, Ontario, Canada
Site 117
Peterborough, Ontario, Canada
Site 113
Sarnia, Ontario, Canada
Site 92
Sarnia, Ontario, Canada
Site 96
Strathroy, Ontario, Canada
Site 112
Montreal, Quebec, Canada
Site 103
Rimouski, Quebec, Canada
Site 119
Sainte-Foy, Quebec, Canada
Site 94
Sainte-Foy, Quebec, Canada
Site 91
Shawinigan, Quebec, Canada
Site 105
Sherbrooke, Quebec, Canada
Site 136
Sherbrooke, Quebec, Canada
Site 124
Moscow, , Russia
Site 125
Moscow, , Russia
Site 126
Moscow, , Russia
Site 128
Moscow, , Russia
Site 129
Moscow, , Russia
Site 130
Moscow, , Russia
Site 132
Moscow, , Russia
Site 133
Moscow, , Russia
Site 127
Saint Petersburg, , Russia
Site 131
Saint Petersburg, , Russia
Site 134
Saint Petersburg, , Russia
Site 138
Saint Petersburg, , Russia
Countries
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Other Identifiers
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2005-002887-27
Identifier Type: -
Identifier Source: secondary_id
S030.2.112
Identifier Type: -
Identifier Source: org_study_id