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Newly Published Menopause Study: 'Bioidentical' and FDA-Approved Divigel(R) (estradiol gel) 0.1 Percent Safe and Effective Treatment for Moderate to Severe Hot Flashes Associated With Menopause
Date:2/17/2009

MAPLE GROVE, Minn., Feb. 17 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. announced today the publication of results of a Phase III study demonstrating that Divigel(R) low-dose transdermal estradiol gel 0.1% is an effective treatment for relief of moderate to severe hot flashes associated with menopause. The objective of the study was to evaluate the efficacy and safety of three doses of Divigel(R) 0.1%, 1.0 mg, 0.5 mg, and, 0.25 mg/day, including the lowest approved dose of estradiol gel or lotion available for the treatment of vasomotor symptoms (1-4). Data showed a statistically significant reduction in frequency and severity of hot flashes as early as week two in patients receiving Divigel(R). The results were published in the January/February edition of Menopause: Journal of the North American Menopause Society (NAMS).

About the Study

A total of 488 postmenopausal women were evaluated in a 12-week study comparing placebo with estradiol gel 0.1% at doses of 1.0, 0.5, and 0.25 mg/day, with estimated daily deliveries of 0.027, 0.009, and 0.003 mg of estradiol, respectively. Primary endpoints were the change from baseline in daily frequency and severity of moderate to severe vasomotor symptoms. Change from baseline in the signs of vulvar and vaginal atrophy (vaginal pH and percentage of superficial cells) was also assessed. Treatment with estradiol gel 0.1% showed statistically significant reductions in frequency and severity of vasomotor symptoms from baseline compared with placebo, as early as Week 2, that were maintained throughout treatment. Signs of vulvar and vaginal atrophy were also significantly improved from baseline with all three doses of estradiol gel 0.1% compared with placebo.

"The development of Divigel(R) expands the bioidentical options for the effective treatment of the symptoms of menopause and offers women the lowest FDA-approved dose of estrogen therapy for hot
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SOURCE Upsher-Smith Laboratories, Inc.
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