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New Study Shows ENJUVIA® Significantly Reduced 'Sleep Time' Awakenings Caused by Hot Flashes in Postmenopausal Women
Date:5/18/2010

SAN FRANCISCO, May 18 /PRNewswire/ -- Teva Women's Health, Inc. today presented data that demonstrated patients treated with a standard or low dose of ENJUVIA® (synthetic conjugated estrogens, B) tablets experienced statistically significant reductions in how often they were awakened at night by hot flashes compared to patients treated with placebo. The data was presented today at the 58th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco.

Hot flashes, caused by menopausal hormone changes, occur in as many as 85 percent of menopausal women, and can be severe enough to negatively impact sleep. The prevalence rate of sleep problems among perimenopausal women and postmenopausal women varies from 31 to 45 percent.

This study evaluated the effectiveness of ENJUVIA (0.3mg and 0.625mg doses) over a 12-week treatment period in reducing the frequency of nighttime sleep awakenings caused by hot flashes in highly symptomatic women. These women were defined as experiencing at least three nighttime awakenings per night at baseline. The study met its primary endpoint of significantly reducing the number of awakenings in both dosing arms with the higher dose achieving a greater mean reduction of 4.56 awakenings per week (p<0.001) than the lower dose (3.55 awakenings per week, p=0.004) relative to placebo. The study did not meet its secondary endpoint of significantly improving individual sleep quality or overall daytime sleepiness as measured by the Stanford Sleepiness Scale Ratings.

"Sleep disruptions due to menopausal symptoms can adversely impact a woman's quality of life," said lead investigator James H. Liu, M.D., Arthur H. Bill Professor and Chair at t
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SOURCE Teva Women's Health, Inc.
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