A Study of MF101 in Postmenopausal Women
- Conditions
- Hot FlushesVasomotor Symptoms
- Interventions
- Registration Number
- NCT00906308
- Lead Sponsor
- Bionovo
- Brief Summary
This phase 3a study is designed to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women.
- Detailed Description
Menopausal women often experience debilitating menopausal vasomotor symptoms and associated insomnia. Until recently, vasomotor symptoms were often treated with estrogens, which are very effective; however, randomized clinical trials have shown that postmenopausal combination hormone therapy increases the risks for stroke, cardiovascular events, and breast cancer. New, more effective, and safer treatments for menopausal vasomotor symptoms are therefore needed.
MF101, a botanical extract, is a non-hormonal investigational treatment being tested in a randomized, double-blind, placebo-controlled phase 3a clinical trial to assess the safety and efficacy of MF101 on the frequency of moderate to severe hot flushes in postmenopausal women. Approximately 1200 healthy post-menopausal women, aged 40-65, with moderate to severe hot flushes will be enrolled to determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo after 12 weeks of treatment.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 1200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - MF101 5 g/day MF101 5 g/day - MF101 10 g/day MF101 10 g/day -
- Primary Outcome Measures
Name Time Method Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo. 12 weeks Safety will be measured through clinically significant findings in physical examinations, laboratory parameters, endometrial changes, abnormal uterine bleeding and any other adverse events. Efficacy will be measured by the mean change in frequency of moderate to severe hot flushes from baseline to treatment week 12.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (43)
Arizona Research Center
🇺🇸Phoenix, Arizona, United States
Visions Clinical Research Center
🇺🇸Tucson, Arizona, United States
Alta Bates Summit Medical Center
🇺🇸Berkeley, California, United States
Northern California Research
🇺🇸Sacramento, California, United States
Genesis Center for Clinical Research
🇺🇸San Diego, California, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Downtown Women's Health Care
🇺🇸Denver, Colorado, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Suncoast Clinical Research
🇺🇸Palm Harbor, Florida, United States
Scroll for more (33 remaining)Arizona Research Center🇺🇸Phoenix, Arizona, United States