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New Data: Efficacy and Responder Analyses of Divigel(R) (estradiol gel) 0.1 percent for the Treatment of Menopause
Date:6/30/2009

t of hot flashes associated with menopause."

About the Study

The responder analysis presented at ACOG was a secondary analysis of the Divigel(R) phase III efficacy and safety study published earlier this year in the journal Menopause. A total of 488 postmenopausal women were evaluated in this 12-week efficacy and safety study, comparing placebo to the low-dose transdermal Divigel(R) at doses of 1.0 mg/day, 0.5 mg/day and 0.25 mg/day estradiol. Endpoints included the change from baseline in daily frequency and severity of moderate to severe hot flashes. The study also evaluated common adverse events and tolerability at the application site. Divigel(R) showed statistically significant improvements compared with placebo as early as week two that were maintained throughout treatment. Divigel(R) significantly decreased the frequency and severity of MSVMS at all doses evaluated in this trial. The most common treatment-related adverse events were breast tenderness and postmenopausal bleeding.

"Divigel(R) offers women the lowest effective FDA-approved dose of estrogen therapy for MSVMS in post-menopausal women and dosing flexibility with availability of three different strengths (0.25 mg estradiol/day, 0.5 mg estradiol/day and 1.0 mg estradiol/day) giving physicians greater ability to individualize treatment for each woman," added Dr. Koltun.

About Divigel(R)

Divigel(R) is indicated for the treatment of MSVMS associated with menopause. 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. Certain older oral estrogen therapies contain conjugated estrogens derived from the urine of pregnant mares. Divigel(R) is applied to the skin and takes a more direct route to the systemic blood stream, bypassing the liver. It is a quick-drying gel that is odorless when dry and is available in convenient, indiv
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SOURCE Upsher-Smith Laboratories, Inc.
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