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Quatrx Pharmaceuticals Presents Results From Ophena(TM) (Ospemifene Tablets) Phase 3 Study Related to Treatment of Symptoms of Vulvovaginal Atrophy
Date:6/16/2008

s the potential to address the most common and debilitating chronic symptoms of vaginal atrophy for millions of women in the years ahead," said Dr. Gloria A. Bachmann, Associate Dean for Women's Health and Professor of Ob/Gyn & Medicine at the University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School.

The study investigated treatment with Ophena(TM) administered orally, once-daily at 30 and 60 mg doses as compared to a placebo. Women were randomized (1:1:1) into a double-blind 12-week treatment period with a four- week follow-up or the opportunity to continue in a long-term safety extension study. All women were supplied with a non-hormonal vaginal lubricant to be applied as needed during the 12-week treatment period.

"These Phase 3 clinical study results also show that treatment with Ophena(TM) has the potential to offer advantages in addition to the use of vaginal lubricants. There are currently no prescription alternatives available for postmenopausal women with symptoms of vaginal atrophy who are concerned about the risks of treatment with estrogen. Over-the-counter vaginal lubricants may help temporarily ease some symptoms of vulvovaginal atrophy associated with intercourse for some women, but they do not treat the underlying progressive condition which is the source of these chronic vaginal symptoms" said Robert Zerbe, M.D., president and chief executive officer of QuatRx.

Following 12 weeks, women treated with 60 mg of Ophena(TM) who identified dryness or painful intercourse as their "most bothersome" symptom, showed significant improvements in each of these symptoms. Women treated with this dose of Ophena(TM) also showed a favorable effect on the health of their vaginal wall cells as compared to the placebo. There was an average 30 percent decrease in parabasal cells (which indicate an atrophic state) as compared to an increase of four percent with placebo and an average 11 percent increase in superficial cel
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SOURCE QuatRx Pharmaceuticals Company
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Related medicine technology :

1. QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena(TM) (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovaginal Atrophy
2. QuatRx Pharmaceuticals Announces Positive Phase 3 Results for Study of Ophena(TM) (ospemifene) to Treat Postmenopausal Vaginal Syndrome
3. QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
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