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MF101, a selective estrogen receptor modulator for the treatment of menopausal hot flushes: a phase II clinical trial

Grady, Deborah MD, MPH1,2; Sawaya, George F. MD1; Johnson, Karen C. MD, MPH3; Koltun, William MD4; Hess, Rachel MD5; Vittinghoff, Eric PhD1; Kristof, Margaret MS, RN1; Tagliaferri, Mary MD, LAC6; Cohen, Isaac OMD, LAC6; Ensrud, Kristine E. MD, MPH7,8

Menopause:
doi: 10.1097/gme.0b013e31818e64dd
Articles
Abstract

Objective: To determine the optimal dose, safety, and efficacy of an estrogen receptor β selective Chinese herbal extract, menopausal formula 101 (MF101), for treating hot flushes.

Methods: A randomized, blinded trial in 217 postmenopausal women with hot flushes randomized to 5 or 10 g/day of MF101 or placebo for 12 weeks.

Results: The effects of 5 g/day of MF101 did not differ from those of placebo. After 12 weeks, the mean percent decrease in frequency of hot flushes in the 10 g/day group was 12.9% greater than that in the placebo group (P = 0.15), the median percent decrease was 11.7% greater than that in the placebo group (P = 0.05), and the proportion of women with at least a 50% reduction in hot flushes was 16.2% greater than that in the placebo group (P = 0.03).

Conclusions: Treatment with 10 g/day of MF101 reduces the frequency of hot flushes. Trials with higher doses are planned.

Author Information

From the 1University of California, San Francisco, San Francisco, CA; 2San Francisco Department of Veterans Affairs Medical Center, San Francisco, CA; 3University of Tennessee Health Science Center, Memphis, TN; 4Medical Center for Clinical Research, San Diego, CA; 5University of Pittsburgh, Pittsburgh, PA; 6Bionovo, Emeryville, CA; 7University of Minnesota, Minneapolis, MN; and 8Minneapolis VA Medical Center, Minneapolis, MN.

Received July 17, 2008; revised and accepted September 18, 2008.

Presented at the annual meeting of The North American Menopause Society at Dallas, TX, on October 5, 2007.

Funding/support: This study was sponsored by Bionovo, Inc, Emeryville, CA.

Financial disclosure: Dr. Grady holds no stock, stock options or other value in any pharmaceutical or biotechnology company and receives no speaker fees or honoraria. She has received support for research in the past 5 years via contract with the University of California, San Francisco from Berlex, Pfizer, Eli Lilly and Bionovo, Inc. She has been paid as a consultant to lead a Data and Safety Monitoring Board for Organon. Dr. Sawaya was funded as site PI by the sponsor, Bionovo, Inc. through specific formal contracts with University of California, San Francisco. Dr. Johnson has received funding for research from Bionovo, Inc. Dr.Hess has received funding for research from Bionovo, Inc. Dr. Tagliaferri is a full time employee of Bionovo, Inc., the manufacturer of the drug and sponsor of the study. She owns a substantial amount of stock in Bionovo, Inc. Dr. Cohen is a full time employee of Bionovo Inc., the manufacturer and sponsor of MF101. He receives all his income from Bionovo Inc. and owns a substantial numbers of shares in the company. Dr. Ensrud has received research grant from Bionovo, Inc. via a contract administered by the University of Minnesota.

Address reprint requests to: Deborah Grady, MD, MPH, University of California, San Francisco, 1635 Divisadero St., Suite 600, San Francisco, CA 94115. E-mail: Deborah.Grady@ucsf.edu

©2009The North American Menopause Society