Clinical Trial: Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Double-Blind, Placebo-Controlled, Randomized Clinical Trial Assessing Toxicity and Efficacy of MF101 for Hot Flashes and Menopausal Symptoms

Brief Summary: The researchers propose a Phase II randomized, double-blind, placebo-controlled trial of 180 healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes per week. Women will be randomized to one of three arms: 4.5 grams/day (dry weight of extract) of MF101, 9.0 grams/day (dry weight of extract) of MF101 or placebo for 12 weeks.

Detailed Summary:
Sponsor: Bionovo

Current Primary Outcome: Frequency and severity of hot flashes

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bionovo

Dates:
Date Received: July 6, 2005
Date Started: February 2006
Date Completion:
Last Updated: May 16, 2007
Last Verified: March 2007