Menopause Clinical Trial
Official title:
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women
| Verified date | April 2008 |
| Source | Solvay Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
| Status | Terminated |
| Enrollment | 133 |
| Est. completion date | March 2008 |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 35 Years to 65 Years |
| Eligibility |
Inclusion Criteria: Hysterectomized, menopausal women between the ages of 30 and 65 years of age (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site 50 | Alpharetta | Georgia |
| United States | Site 31 | Anderson | South Carolina |
| United States | Site 53 | Ann Arbor | Michigan |
| United States | Site 5 | Atlanta | Georgia |
| United States | Site 10 | Aventura | Florida |
| United States | Site 59 | Baton Rouge | Louisiana |
| United States | Site 72 | Billings | Montana |
| United States | Site 47 | Boise | Idaho |
| United States | Site 68 | Carmichael | California |
| United States | Site 65 | Cary | North Carolina |
| United States | Site 24 | Champaign | Illinois |
| United States | Site 4 | Chattanooga | Tennessee |
| United States | Site 20 | Chicago | Illinois |
| United States | Site 78 | Clearwater | Florida |
| United States | Site 60 | Columbus | Ohio |
| United States | Site 74 | Conroe | Texas |
| United States | Site 8 | Corpus Christi | Texas |
| United States | Site 71 | Dallas | Texas |
| United States | Site 44 | Decatur | Georgia |
| United States | Site 26 | Denver | Colorado |
| United States | Site 77 | Douglasville | Georgia |
| United States | Site 55 | Encinitas | California |
| United States | Site 18 | Erie | Pennsylvania |
| United States | Site 62 | Eugene | Oregon |
| United States | Site 58 | Evansville | Indiana |
| United States | Site 73 | Ft. Myers | Florida |
| United States | Site 35 | Greer | South Carolina |
| United States | Site 1 | Groton | Connecticut |
| United States | Site 54 | Hartford | Connecticut |
| United States | Site 42 | Houston | Texas |
| United States | Site 66 | Huntsville | Alabama |
| United States | Site 3 | Jonesboro | Arkansas |
| United States | Site 63 | Kansas City | Missouri |
| United States | Site 51 | Leesburg | Florida |
| United States | Site 21 | Lincoln | Nebraska |
| United States | Site 22 | Little Rock | Arkansas |
| United States | Site 41 | Medford | Oregon |
| United States | Site 49 | Melbourne | Florida |
| United States | Site 57 | Mobile | Alabama |
| United States | Site 46 | Montgomery | Alabama |
| United States | Site 13 | New Bern | North Carolina |
| United States | Site 52 | New Orleans | Louisiana |
| United States | Site 64 | New Port Richey | Florida |
| United States | Site 28 | Norfolk | Virginia |
| United States | Site 61 | Ocala | Florida |
| United States | Site 67 | Oklahoma City | Oklahoma |
| United States | Site 27 | Palm Springs | Florida |
| United States | Site 76 | Peoria | Illinois |
| United States | Site 19 | Philadelphia | Pennsylvania |
| United States | Site 29 | Phoenix | Arizona |
| United States | Site 11 | Pinellas Park | Florida |
| United States | Site 33 | Portland | Oregon |
| United States | Site 23 | Pottstown | Pennsylvania |
| United States | Site 37 | Reno | Nevada |
| United States | Site 56 | Renton | Washington |
| United States | Site 12 | Richmond | Virginia |
| United States | Site 32 | Richmond Heights | Missouri |
| United States | Site 9 | Riverdale | Georgia |
| United States | Site 38 | Salt Lake City | Utah |
| United States | Site 14 | San Antonio | Texas |
| United States | Site 6 | San Diego | California |
| United States | Site 45 | Santa Rosa | California |
| United States | Site 75 | Sarasota | Florida |
| United States | Site 7 | Savannah | Georgia |
| United States | Site 2 | Seattle | Washington |
| United States | Site 48 | Spokane | Washington |
| United States | Site 36 | St. Louis | Missouri |
| United States | Site 69 | St. Petersburg | Florida |
| United States | Site 43 | Tacoma | Washington |
| United States | Site 30 | Trumbull | Connecticut |
| United States | Site 15 | Tucson | Arizona |
| United States | Site 40 | Tulsa | Oklahoma |
| United States | Site 70 | Venice | Florida |
| United States | Site 25 | Walnut Creek | California |
| United States | Site 34 | Waterbury | Connecticut |
| United States | Site 17 | West Palm Beach | Florida |
| United States | Site 39 | Wichita | Kansas |
| United States | Site 16 | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Solvay Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in the total score of the Menopause Rating Scale (MRS) | 12 weeks | No | |
| Secondary | Change from baseline in the domain and individual item scores of the MRS | 12 weeks | No | |
| Secondary | Change from baseline in the domain scores of the MENQOL | monthly for 3 months | No | |
| Secondary | Comparison of changes in hormone levels and correlation with changes in the MRS | 12 weeks | No |
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