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| Descriptive Information Fields | |||||
| Brief Title † | The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women | ||||
| Official Title † | A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Hysterectomized Postmenopausal Women | ||||
| Brief Summary | To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | Change from baseline in the total score of the Menopause Rating Scale (MRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Change from baseline in the domain and individual item scores of the MRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Change from baseline in the domain scores of the MENQOL [ Time Frame: monthly for 3 months ] [ Designated as safety issue: No ] Comparison of changes in hormone levels and correlation with changes in the MRS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] |
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| Condition † | Menopause | ||||
| Intervention † | Drug: esterified estrogens 1.25mg and methyltestosterone 2.5mg Drug: Esterified estrogens 1.25 mg |
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| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 133 | ||||
| Start Date † | July 2004 | ||||
| Completion Date | March 2008 | ||||
| Eligibility Criteria † | 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 |
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| Gender | Female | ||||
| Ages | 35 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00141557 | ||||
| Organization ID | S030.2.110 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Solvay Pharmaceuticals | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Solvay Pharmaceuticals | ||||
| Verification Date | April 2008 | ||||
| First Received Date † | August 30, 2005 | ||||
| Last Updated Date | April 10, 2008 | ||||
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