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New Data Reveal Topical Divigel(R) (estradiol gel) 0.1% Significantly Reduces Frequency and Severity of Hot Flashes
Date:10/3/2007

.0 g gel/day, 0.5 g gel/day and 0.25 g gel/day. Approximately 120 patients were randomized to each treatment group. Study endpoints included mean change from baseline in daily frequency and severity of moderate to severe hot flashes.

Consistent with FDA requirements, both the Divigel(R) 0.5 g and 1.0 g treatment groups demonstrated a statistically significant reduction in the frequency and severity of vasomotor symptoms by week four. The Divigel(R) 0.25 g group demonstrated a statistically significant reduction in the frequency and severity of vasomotor symptoms by week seven. Statistically significant differences were maintained through the duration of treatment (12 weeks). Divigel(R) also had an excellent tolerability profile and less than one percent of patients experienced skin irritation reactions at the treatment application site.

Divigel(R) was approved by the U.S. Food and Drug Administration (FDA) in June 2007. The estrogen in Divigel(R) is derived from plant sources and is identical to the primary estrogen produced by a woman's ovaries before menopause. Divigel(R) is a quick-drying gel that is odorless when dry, and is available in convenient, individual-use packets. One packet of gel is applied daily to an area that measures approximately 5 x 7 inches on the thigh, the smallest application area compared to all other available gel or lotion estrogen products. Divigel(R) also offers dosing flexibility with three different strengths (0.25 mg estradiol/day, 0.5 mg estradiol/day and 1.0 mg estradiol/day) to individualize treatment for each woman.

For more information, call 1-800-654-2299 or visit http://www.divigelus.com.


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SOURCE Comprehensive Clinical Trials
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