BIO-E-GELTM Thwarts Postmenopausal Hot Flashes

Main Category: Menopause
Also Included In: Endocrinology
Article Date: 11 Mar 2006 - 0:00 PDT

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BIO-E GELTM is an effective and safe treatment for vasomotor symptoms in postmenopausal women, according to phase III data presented today at the annual meeting of the International Society for the Study of Women's Sexual Health (ISSWSH).

The results also identified the lowest effective dose of BIO-E-GELTM in order to implement estrogen therapy in the safest possible manner.

BIO-E-GELTM is an investigational transdermal estradiol gel.

Stephen Simes, President and CEO of BioSante Pharmaceuticals, Inc. in Lincolnshire, Illinois, presented results in 484 healthy, postmenopausal women who were randomized to 12 weeks' treatment with the topically applied gel or placebo. All subjects had experienced at least 120 moderate to severe hot flashes during a 14-day screening period.

Participants were assigned to one of four treatment arms: low-dose BIO-E-GELTM, mid-dose BIO-E-GELTM, high-dose BIO-E-GELTM, or matching placebo.

All women maintained a diary that recorded the number and severity of daily hot flashes.

The primary endpoints were a significant decrease over placebo in both the number and severity of hot flashes at week four and week 12 of treatment.

Results showed a clear dose-response in the reduction in the number and severity of hot flashes across the low, mid, and high BIO-E-GELTM doses tested.

The most effective BIO-E-GELTM dose decreased the number of hot flashes by 88 percent, from 12.9 per day at baseline to 1.6 per day after 12 weeks of treatment - amounting to a mean decrease of 11.3 hot flashes per day. This improvement was highly significant (p less than 0.0001) compared to a mean decrease of 6.1 daily hot flashes with placebo (p less than 0.0001).

The lowest dose of BIO-E-GELTM was also effective and produced low estradiol blood levels with a safety profile similar to that observed in the placebo group.

Application site reactions were uncommon. "This is important because application site reactions have been associated with the use of transdermal patches," Simes said.

"Transdermal BIO-E-GELTM offers an important advantage over oral estrogen products by providing bio-identical estrogen which is not subject to first-pass liver metabolism, thus avoiding side effects associated with oral administration of conjugated estrogen," he noted. Currently, oral conjugated estrogen is the most popular treatment for menopausal symptoms.

BioSante filed a New Drug Application for BIO-E-GELTM with the U.S. Food and Drug Administration in mid-February.

The North American Menopause Society estimates that more than two-thirds of North American women have hot flashes during peri-menopause.

By Jill Stein - a Paris-based freelance medical writer.

http://www.biosantepharma.com

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