Hot Flushes, Menopause, Postmenopause Clinical Trial
Official title:
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
| Status | Completed |
| Enrollment | 1251 |
| Est. completion date | September 2007 |
| Est. primary completion date | September 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 45 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Site 120 | Abbotsford | British Columbia |
| 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 112 | Montreal | Quebec |
| Canada | Site 106 | Newmarket | Ontario |
| Canada | Site 100 | North Vancouver | British Columbia |
| Canada | Site 137 | Ottawa | Ontario |
| Canada | Site 117 | Peterborough | Ontario |
| Canada | Site 103 | Rimouski | Quebec |
| Canada | Site 119 | Sainte Foy | Quebec |
| Canada | Site 94 | Sainte Foy | Quebec |
| Canada | Site 113 | Sarnia | Ontario |
| Canada | Site 92 | Sarnia | Ontario |
| Canada | Site 91 | Shawinigan | Quebec |
| Canada | Site 105 | Sherbrooke | Quebec |
| Canada | Site 136 | Sherbrooke | Quebec |
| Canada | Site 111 | St. John's | Newfoundland and Labrador |
| Canada | Site 96 | Strathroy | Ontario |
| Canada | Site 135 | Victoria | British Columbia |
| Canada | Site 116 | West Vancouver | British Columbia |
| Canada | Site 122 | Winnipeg | Manitoba |
| Canada | Site 93 | Winnipeg | Manitoba |
| 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 | Moscow | |
| Russian Federation | Site 127 | St. Petersburg | |
| Russian Federation | Site 131 | St. Petersburg | |
| Russian Federation | Site 134 | St. Petersburg | |
| Russian Federation | Site 138 | St. Petersburg | |
| United States | Site 40 | Alpharetta | Georgia |
| United States | Site 90 | Alpharetta | Georgia |
| United States | Site 43 | Ann Arbor | Michigan |
| United States | Site 23 | Atlanta | Georgia |
| United States | Site 8 | Atlanta | Georgia |
| United States | Site 25 | Aventura | Florida |
| United States | Site 26 | Aventura | Florida |
| United States | Site 52 | Baton Rouge | Louisiana |
| United States | Site 17 | Billings | Montana |
| United States | Site 76 | Boise | Idaho |
| United States | Site 86 | Bryan | Texas |
| United States | Site 70 | Carmichael | California |
| United States | Site 85 | Carmichael | California |
| United States | Site 64 | Champaign | Illinois |
| United States | Site 47 | Charlottesville | Virginia |
| United States | Site 12 | Chaska | Minnesota |
| United States | Site 10 | Chattanooga | Tennessee |
| United States | Site 80 | Chesterfield | Missouri |
| United States | Site 58 | Chicago | Illinois |
| United States | Site 72 | Chicago | Illinois |
| United States | Site 74 | Chicago | Illinois |
| United States | Site 45 | Cincinnati | Ohio |
| United States | Site 81 | Cincinnati | Ohio |
| United States | Site 51 | Clearwater | Florida |
| United States | Site 71 | Clearwater | Florida |
| United States | Site 53 | Columbus | Ohio |
| United States | Site 20 | Corpus Christi | Texas |
| United States | Site 61 | Daytona Beach | Florida |
| United States | Site 66 | Denver | Colorado |
| United States | Site 50 | Evansville | Indiana |
| United States | Site 75 | Gainesville | Florida |
| United States | Site 24 | Greenville | South Carolina |
| United States | Site 4 | Groton | Connecticut |
| United States | Site 67 | Hilton Head | South Carolina |
| United States | Site 11 | Houston | Texas |
| United States | Site 6 | Jonesboro | Arkansas |
| United States | Site 16 | Kansas City | Missouri |
| United States | Site 19 | Kansas City | Missouri |
| United States | Site 7 | Las Vegas | Nevada |
| United States | Site 36 | Lincoln | Nebraska |
| United States | Site 62 | Little Rock | Arkansas |
| United States | Site 15 | Lutherville | Maryland |
| United States | Site 65 | Mandeville | Louisiana |
| United States | Site 34 | Mayfield Heights | Ohio |
| United States | Site 88 | Memphis | Tennessee |
| United States | Site 73 | Metarie | Louisiana |
| United States | Site 78 | Mogadore | Ohio |
| United States | Site 37 | Montgomery | Alabama |
| United States | Site 69 | Montgomery | Alabama |
| United States | Site 56 | Nashville | Tennessee |
| United States | Site 39 | New Bern | North Carolina |
| United States | Site 35 | New Britain | Connecticut |
| United States | Site 2 | Norfolk | Virginia |
| United States | Site 87 | Northridge | California |
| United States | Site 33 | Pensacola | Florida |
| United States | Site 84 | Philadelphia | Pennsylvania |
| United States | Site 13 | Portland | Oregon |
| United States | Site 89 | Portland | Oregon |
| United States | Site 63 | Pottstown | Pennsylvania |
| United States | Site 60 | Powder Springs | Georgia |
| United States | Site 79 | Raleigh | North Carolina |
| United States | Site 28 | Reno | Nevada |
| United States | Site 29 | Richmond | Virginia |
| United States | Site 48 | Richmond | Virginia |
| United States | Site 49 | Salt Lake City | Utah |
| United States | Site 30 | San Antonio | Texas |
| United States | Site 41 | San Antonio | Texas |
| United States | Site 18 | San Diego | California |
| United States | Site 27 | San Diego | California |
| United States | Site 54 | San Diego | California |
| United States | Site 55 | Savannah | Georgia |
| United States | Site 5 | Seattle | Washington |
| United States | Site 38 | Spokane | Washington |
| United States | Site 3 | St. Louis | Missouri |
| United States | Site 21 | Stuart | Florida |
| United States | Site 32 | Tacoma | Washington |
| United States | Site 82 | Tampa | Florida |
| United States | Site 44 | Tucson | Arizona |
| United States | Site 77 | Tulsa | Oklahoma |
| United States | Site 9 | Venice | Florida |
| United States | Site 42 | Virginia Beach | Virginia |
| United States | Site 31 | Vista | California |
| United States | Site 68 | Walnut Creek | California |
| United States | Site 22 | Warwick | Rhode Island |
| United States | Site 14 | Waterbury | Connecticut |
| United States | Site 83 | West Palm Beach | Florida |
| United States | Site 46 | Winston Salem | North Carolina |
| United States | Site 59 | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States, Canada, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4 | 4 weeks | No | |
| Primary | Mean change in frequency of moderate to severe VMS from baseline to Week 12 | 12 weeks | No | |
| Primary | Mean change in severity of moderate to severe VMS from baseline to Week 4 | 4 weeks | No | |
| Primary | Mean change in severity of moderate to severe VMS from baseline to Week 12 | 12 weeks | No | |
| Secondary | Frequency and severity of moderate to severe and all hot flushes at each week | 12 weeks | No | |
| Secondary | 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 | No | |
| Secondary | Mean change from baseline to Week 12 in vaginal pH | 12 weeks | No | |
| Secondary | Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells) | 12 weeks | No |