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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,200
PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks
Determine the safety and efficacy of two doses of MF101 (5 g/day and 10 g/day) compared to placebo.
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.
Time frame: 12 weeks
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