NCT00906308

A Study of MF101 in Postmenopausal Women

A Phase 3, Double-blind, Placebo-Controlled, Randomized Clinical Trial, Assessing Safety and Efficacy of MF101 for Hot Flushes and Menopausal Symptoms in Postmenopausal Women

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Bionovo · Industry
• Sex: Female
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hot Flushes
• Vasomotor Symptoms

Interventions

Type	Name	Description
DRUG	MF101 5 g/day	PO (orally) 5 g/day (administered twice a day, BID) for up to 12 weeks
DRUG	Placebo	PO (orally) matched placebo (administered twice a day, BID) for up to 12 weeks
DRUG	MF101 10 g/day	PO (orally) 10 g/day (administered twice a day, BID) for up to 12 weeks

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-02-01
• First posted: 2009-05-21
• Last updated: 2012-02-08

Locations

50 sites across 1 country: United States