New Drug May Offer Cool Relief Of Hot Flashes For Millions Of Women

Main Category: Menopause
Also Included In: Primary Care / General Practice;  Endocrinology;  Clinical Trials / Drug Trials
Article Date: 10 May 2006 - 0:00 PDT

email to a friend   printer friendly   opinions  

Hot flashes afflict most menopausal women, with some experiencing severe and disruptive hot flashes, seven or more times a day, for many years. Fortunately, new discoveries may offer relief -- without the use of controversial hormone replacement therapies.

Drs. Isaac Cohen and Mary Tagliaferri, and their team at Bionovo, Inc., have developed an oral drug designed to minimize a woman's vasomotor symptoms, such as hot flashes and night sweats. The non-steroidal estrogen-receptor beta compound is based on plant extracts discovered by Company scientists. Clinical studies demonstrated that the novel plant-based therapy is safe and well tolerated by menopausal women.

"At present, women contemplating hormone replacement therapy for relief of hot flashes and other menopause-related symptoms still face confusion and controversy," says Dr. Tagliaferri, Bionovo's Medical Director. "Many health professionals have no ready answers to offer women about the risk-benefit ratio with regard to the heart, breast, bone density, skin condition and other areas of the body that could be affected. This leaves women up in the air on the value of taking estrogen at all."

An alternative to estrogen: Bionovo's proprietary oral treatment, MF 101. The drug is now being tested in a multi-center, randomized, placebo-controlled Phase II Clinical Study, designed to evaluate, in postmenopausal women, the change in frequency and severity of hot flashes from baseline to 12 weeks. Dr. Deborah Grady, renowned authority figure on women's health at the University of California, San Francisco, is serving as the Principal Investigator of the study. Recruitment for the trial is also taking place at the University of Alabama, the University of Minnesota and the University of Tennessee.

The women in the trial, ages 40-60, experience seven or more hot flashes a day, or more than 50 a week. A total of 180 women are taking the drug for three months; 60 will be randomized to take dose one of MF101, 60 will take dose two, and 60 will receive a placebo.

For more information, visit http://www.bionovo.com.

Bionovo, Inc.
http://www.bionovo.com

• Additional
• References
• Citations