The Efficacy of ESTRATEST® Tablets in Relieving Menopausal Symptoms in Estrogenized, Non-Hysterectomized Postmenopausal Women
- Conditions
- Menopause
- Interventions
- Drug: Esterified estrogens 1.25 mg
- Registration Number
- NCT00141544
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
To determine whether treatment with ESTRATEST® Tablets is superior to treatment with esterified estrogens tablets
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 28
Non-hysterectomized, menopausal women between the ages of 35 and 65 years (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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 esterified estrogens 1.25 mg and methyltestosterone 2.5 mg - 2 Esterified estrogens 1.25 mg -
- Primary Outcome Measures
Name Time Method Change from baseline in the total score of the Menopause Rating Scale (MRS) 12 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in the domain and individual item scores of the MRS 12 weeks Change from baseline in the domain scores of the MENQOL monthly for 3 months Comparison of changes in hormone levels and correlation with changes in the MRS 12 weeks
Trial Locations
- Locations (78)
Site 66
🇺🇸Huntsville, Alabama, United States
Site 57
🇺🇸Mobile, Alabama, United States
Site 46
🇺🇸Montgomery, Alabama, United States
Site 29
🇺🇸Phoenix, Arizona, United States
Site 15
🇺🇸Tucson, Arizona, United States
Site 3
🇺🇸Jonesboro, Arkansas, United States
Site 22
🇺🇸Little Rock, Arkansas, United States
Site 68
🇺🇸Carmichael, California, United States
Site 55
🇺🇸Encinitas, California, United States
Site 6
🇺🇸San Diego, California, United States
Scroll for more (68 remaining)Site 66🇺🇸Huntsville, Alabama, United States