Low-Dose Estradiol Gel Controls Menopausal Symptoms

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NEW YORK (Reuters Health) Mar 12 - Elestrin (BioSante Pharmaceutics, Inc.), a new transdermal estradiol gel, appears to relieve menopausal symptoms, while keeping hormone exposure to a minimum, researchers report in the March issue of Obstetrics and Gynecology.

A number of authorities, senior investigator Dr. Michael C. Snabes told Reuters Health, have "provided guidelines for physicians to prescribe the lowest possible dose of estrogen to treat menopausal symptoms."

The Elestrin study, he added, "accomplished this with a dose of estradiol that is 50% lower than the next lowest dose of estradiol approved for menopausal symptoms."

Dr. Snabes of BioSante Pharmaceutics, Inc., Lincolnshire, Illinois, and colleagues came to this conclusion after studying 484 postmenopausal women who had at least 60 hot flushes per week.

They were randomized in a double-blind fashion to 0.87, 1.7 or 2.6 grams per day of the estradiol gel or placebo, applied to a small area of the upper arm for 12 weeks.

After 3 to 5 weeks, the gel reduced the moderate-to-severe hot flush rate by at least 7 hot flushes per day and also significantly reduced the severity score.

The lowest-dose gel significantly improved most bothersome vulvovaginal atrophy symptoms. It was well tolerated at the site of application and produced the fewest adverse effects.

The investigators conclude that the 0.87-g dose formulation, which delivers an estimated 0.0125 mg estradiol daily, "delivered the lowest effective dose for treatment of vasomotor symptoms and vulvovaginal atrophy in a population of postmenopausal women."

Dr. Snabes pointed out that "if estrogen use in postmenopausal women is associated with higher rates of serious adverse events -- and this is still debated -- these very low doses of estradiol in Elestrin could, over the long-run, be shown to decrease the rate of serious adverse events such as MI, stroke and breast cancer."

"However," he concluded, "this assertion remains unproven and would require a large, carefully conducted study."

In an accompanying editorial, Dr. Cheryl B. Iglesia of Washington Hospital Center, Washington, DC agrees, pointing out that "longer term follow-up is needed to assess for endometrial hyperplasia...and to assess for the risk of heart disease, breast cancer and stroke."

The study was supported by BioSante Pharmaceuticals, Inc.

Obstet Gynecol 2007;109:578-580,588-596.

Source: http://www.medscape.com/viewarticle/553474?src=mp