Last updated on February 2012

A Study of MF101 in Postmenopausal Women


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT00906308

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Jesse Langon, MPH

Mount Vernon Clinical Research
Sandy Springs, GA United States
2.47miles
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