Comparison of Estrogen and Methyltestosterone Combination Treatments for Postmenopausal Hot Flushes
- Conditions
- Hot Flushes, Menopause, Postmenopause
- Interventions
- Registration Number
- NCT00160342
- Lead Sponsor
- Solvay Pharmaceuticals
- Brief Summary
This is a research study to evaluate the effectiveness, safety and side effects of several dose levels of esterified estrogens (EE) and methyltestosterone (MT) given individually and in combination compared to a placebo (a tablet with no active drug in it) as a possible treatment for vasomotor symptoms (such as hot flushes and flushing) of menopause. EE and testosterone are two hormones which are typically deficient in menopausal women
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1251
- Be able to communicate with the Investigator and study staff and be able to complete the required study procedures,
- Be a female of any race between the ages of 45-65 years, in generally good health,
- Be either naturally or surgically postmenopausal (with or without a uterus)
- Known sensitivity or contraindications to natural or synthetic estrogens, androgens or progestins,
- History of or current diagnosis of malignant melanoma, breast cancer or any cancer (except non-melanomatous skin cancer) diagnosed less than 5 years prior to beginning the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 Esterified Estrogens (EE) and Methyltestosterone (MT) - 7 Esterified Estrogens (EE) and Methyltestosterone (MT) - 8 Esterified Estrogens (EE) and Methyltestosterone (MT) - 9 Esterified Estrogens (EE) and Methyltestosterone (MT) - 1 Esterified Estrogens (EE) and Methyltestosterone (MT) - 2 Esterified Estrogens (EE) and Methyltestosterone (MT) - 3 Esterified Estrogens (EE) and Methyltestosterone (MT) - 4 Esterified Estrogens (EE) and Methyltestosterone (MT) - 5 Esterified Estrogens (EE) and Methyltestosterone (MT) -
- Primary Outcome Measures
Name Time Method Mean change in frequency of moderate to severe vasomotor symptoms (VMS) from baseline to Week 4 4 weeks Mean change in frequency of moderate to severe VMS from baseline to Week 12 12 weeks Mean change in severity of moderate to severe VMS from baseline to Week 4 4 weeks Mean change in severity of moderate to severe VMS from baseline to Week 12 12 weeks
- Secondary Outcome Measures
Name Time Method Frequency and severity of moderate to severe and all hot flushes at each week 12 weeks Mean change from baseline to Week 12 in the moderate to severe vulvar and vaginal atrophy symptom identified by the subject as most bothersome 12 weeks Mean change from baseline to Week 12 in vaginal pH 12 weeks Mean change from baseline to Week 12 in vaginal maturation index (parabasal and superficial cells) 12 weeks
Trial Locations
- Locations (125)
Site 37
🇺🇸Montgomery, Alabama, United States
Site 69
🇺🇸Montgomery, Alabama, United States
Site 44
🇺🇸Tucson, Arizona, United States
Site 6
🇺🇸Jonesboro, Arkansas, United States
Site 62
🇺🇸Little Rock, Arkansas, United States
Site 70
🇺🇸Carmichael, California, United States
Site 85
🇺🇸Carmichael, California, United States
Site 87
🇺🇸Northridge, California, United States
Site 18
🇺🇸San Diego, California, United States
Site 27
🇺🇸San Diego, California, United States
Scroll for more (115 remaining)Site 37🇺🇸Montgomery, Alabama, United States