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| Sponsor: | Solvay Pharmaceuticals |
|---|---|
| Information provided by: | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00141557 |
Purpose
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
| Condition | Intervention | Phase |
|---|---|---|
|
Menopause |
Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg Drug: Esterified estrogens 1.25 mg |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women |
| Enrollment: | 133 |
| Study Start Date: | July 2004 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg
ESTRATEST® administered orally QD
|
| 2: Active Comparator |
Drug: Esterified estrogens 1.25 mg
Esterified estrogens 1.25 mg administered orally QD
|
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Site 46 | |
| Montgomery, Alabama, United States | |
| Site 57 | |
| Mobile, Alabama, United States | |
| Site 66 | |
| Huntsville, Alabama, United States | |
| United States, Arizona | |
| Site 15 | |
| Tucson, Arizona, United States | |
| Site 29 | |
| Phoenix, Arizona, United States | |
| United States, Arkansas | |
| Site 3 | |
| Jonesboro, Arkansas, United States | |
| Site 22 | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Site 6 | |
| San Diego, California, United States | |
| Site 25 | |
| Walnut Creek, California, United States | |
| Site 45 | |
| Santa Rosa, California, United States | |
| Site 55 | |
| Encinitas, California, United States | |
| Site 68 | |
| Carmichael, California, United States | |
| United States, Colorado | |
| Site 26 | |
| Denver, Colorado, United States | |
| United States, Connecticut | |
| Site 30 | |
| Trumbull, Connecticut, United States | |
| Site 34 | |
| Waterbury, Connecticut, United States | |
| Site 54 | |
| Hartford, Connecticut, United States | |
| Site 1 | |
| Groton, Connecticut, United States | |
| United States, Florida | |
| Site 10 | |
| Aventura, Florida, United States | |
| Site 11 | |
| Pinellas Park, Florida, United States | |
| Site 17 | |
| West Palm Beach, Florida, United States | |
| Site 27 | |
| Palm Springs, Florida, United States | |
| Site 49 | |
| Melbourne, Florida, United States | |
| Site 51 | |
| Leesburg, Florida, United States | |
| Site 61 | |
| Ocala, Florida, United States | |
| Site 75 | |
| Sarasota, Florida, United States | |
| Site 69 | |
| St. Petersburg, Florida, United States | |
| Site 70 | |
| Venice, Florida, United States | |
| Site 73 | |
| Ft. Myers, Florida, United States | |
| Site 64 | |
| New Port Richey, Florida, United States | |
| Site 78 | |
| Clearwater, Florida, United States | |
| United States, Georgia | |
| Site 5 | |
| Atlanta, Georgia, United States | |
| Site 7 | |
| Savannah, Georgia, United States | |
| Site 9 | |
| Riverdale, Georgia, United States | |
| Site 44 | |
| Decatur, Georgia, United States | |
| Site 50 | |
| Alpharetta, Georgia, United States | |
| Site 77 | |
| Douglasville, Georgia, United States | |
| United States, Idaho | |
| Site 47 | |
| Boise, Idaho, United States | |
| United States, Illinois | |
| Site 20 | |
| Chicago, Illinois, United States | |
| Site 24 | |
| Champaign, Illinois, United States | |
| Site 76 | |
| Peoria, Illinois, United States | |
| United States, Indiana | |
| Site 58 | |
| Evansville, Indiana, United States | |
| United States, Kansas | |
| Site 39 | |
| Wichita, Kansas, United States | |
| United States, Louisiana | |
| Site 52 | |
| New Orleans, Louisiana, United States | |
| Site 59 | |
| Baton Rouge, Louisiana, United States | |
| United States, Michigan | |
| Site 53 | |
| Ann Arbor, Michigan, United States | |
| United States, Missouri | |
| Site 32 | |
| Richmond Heights, Missouri, United States | |
| Site 36 | |
| St. Louis, Missouri, United States | |
| Site 63 | |
| Kansas City, Missouri, United States | |
| United States, Montana | |
| Site 72 | |
| Billings, Montana, United States | |
| United States, Nebraska | |
| Site 21 | |
| Lincoln, Nebraska, United States | |
| United States, Nevada | |
| Site 37 | |
| Reno, Nevada, United States | |
| United States, North Carolina | |
| Site 13 | |
| New Bern, North Carolina, United States | |
| Site 16 | |
| Winston-Salem, North Carolina, United States | |
| Site 65 | |
| Cary, North Carolina, United States | |
| United States, Ohio | |
| Site 60 | |
| Columbus, Ohio, United States | |
| United States, Oklahoma | |
| Site 40 | |
| Tulsa, Oklahoma, United States | |
| Site 67 | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| Site 33 | |
| Portland, Oregon, United States | |
| Site 41 | |
| Medford, Oregon, United States | |
| Site 62 | |
| Eugene, Oregon, United States | |
| United States, Pennsylvania | |
| Site 18 | |
| Erie, Pennsylvania, United States | |
| Site 19 | |
| Philadelphia, Pennsylvania, United States | |
| Site 23 | |
| Pottstown, Pennsylvania, United States | |
| United States, South Carolina | |
| Site 31 | |
| Anderson, South Carolina, United States | |
| Site 35 | |
| Greer, South Carolina, United States | |
| United States, Tennessee | |
| Site 4 | |
| Chattanooga, Tennessee, United States | |
| United States, Texas | |
| Site 8 | |
| Corpus Christi, Texas, United States | |
| Site 14 | |
| San Antonio, Texas, United States | |
| Site 42 | |
| Houston, Texas, United States | |
| Site 71 | |
| Dallas, Texas, United States | |
| Site 74 | |
| Conroe, Texas, United States | |
| United States, Utah | |
| Site 38 | |
| Salt Lake City, Utah, United States | |
| United States, Virginia | |
| Site 12 | |
| Richmond, Virginia, United States | |
| Site 28 | |
| Norfolk, Virginia, United States | |
| United States, Washington | |
| Site 56 | |
| Renton, Washington, United States | |
| Site 43 | |
| Tacoma, Washington, United States | |
| Site 48 | |
| Spokane, Washington, United States | |
| Site 2 | |
| Seattle, Washington, United States | |
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Responsible Party: | Solvay Pharmaceuticals ( Cindy Lane ) |
| Study ID Numbers: | S030.2.110 |
| Study First Received: | August 30, 2005 |
| Last Updated: | April 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00141557 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Menopause; Postmenopause; Estrogen; Hormone Therapy |
|
Estrogens Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Methyltestosterone Hormones Pharmacologic Actions |
Testosterone 17 beta-cypionate Estrogens, Esterified (USP) Testosterone Anabolic Agents Therapeutic Uses Androgens Estrone |
