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| Sponsored by: |
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 |
| MedlinePlus related topics: | Menopause |
| ChemIDplus related topics: | Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate |
| 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![]() |
Show 78 Study Locations |
| Solvay Pharmaceuticals |
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Responsible Party: | Solvay Pharmaceuticals ( Cindy Lane ) |
| Study ID Numbers: | S030.2.110 |
| First Received: | August 30, 2005 |
| Last Updated: | April 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00141557 |
| Health Authority: | United States: Food and Drug Administration |
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