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Clinical trial of new Bionovo menopause drug moves forward

Published on February 27, 2006 at 2:01 PM · No Comments

Today, millions of women suffer from often-harsh symptoms of menopause such as hot flashes and night sweats -- and relief is nowhere to be found.

Now a pharmaceutical company called Bionovo Inc. has completed medical studies that show that selective estrogen receptor modulators found in their lead drug, Menopause Formula 101 (MF101) may safely address those debilitating symptoms of menopause.

Now in a Phase 2 clinical trial of MF101, Bionovo has begun recruiting participants to evaluate them for the treatment of menopausal symptoms. MF101 is a selective estrogen receptor modulator that is unlike any currently available hormone therapies.

This second clinical trial of MF101 followed the initial trial conducted at the University of California, San Francisco under the auspices of renowned researcher Dr. Deborah Grady. Laboratory data obtained in that study demonstrated that MF101 does not stimulate estrogen dependent tumor formation or uterine proliferation, and therefore may prove to be a safer alternative to the currently available hormone therapies.

In the initial clinical trial, MF101 provided ongoing relief from symptomatic vasomotor symptoms of menopause such as hot flashes and night sweats, while minimizing the risks associated with hormone therapy by exerted effects on only one of the two known estrogen receptors in the brain, the estrogen receptor beta.

In 2002, the Women's Health Initiative (WHI) Estrogen Plus Progestin Trial, with over 16,000 women participants, was stopped early when it was found that the standard dose of combination hormone therapy increased the risk of breast cancer, stroke, heart attacks, blood clots and dementia.

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