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QuatRx Pharmaceuticals Announces Additional Data From Phase 3 Study for Ophena(TM) (Ospemifene Tablets) Showing Improvements in Clinical Symptoms of Vulvovaginal Atrophy
Date:9/24/2008

Separate survey shows high prevalence of "bothersome" vaginal atrophy symptoms among sexually active and non-sexually active postmenopausal women; results presented today at 19th Annual North American Menopause

Society Meeting

ANN ARBOR, Mich., Sept. 24 /PRNewswire/ -- Additional results of a Phase 3 study for Ophena(TM) (ospemifene tablets) for the treatment of symptoms of vulvovaginal atrophy (VVA) in postmenopausal women showed that Ophena(TM) significantly improves a broad range of clinical signs of vulvovaginal atrophy, including petechiae, pallor, friability, vaginal dryness and redness in mucosa. These are all visual observations of VVA assessed during gynecological examination and were pre-defined secondary endpoints in the study. Results were announced today by QuatRx Pharmaceuticals in a poster presentation at the 19th Annual North American Menopause Society meeting in Orlando, Florida.

Vulvovaginal atrophy is a common and progressive condition associated with menopause. Earlier this year, QuatRx announced a Phase 3 study for Ophena(TM) met all four of its co-primary endpoints. The results of the study showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), two of the most bothersome symptoms associated with VVA. The study also demonstrated favorable effects of Ophena(TM) on vaginal wall health as compared to placebo, measured as changes in the proportion of parabasal and superficial cells in the vaginal epithelium, as well as a favorable effect on vaginal pH levels.

The multi-center, double-blind, placebo-controlled study was conducted at 80 U.S. centers and involved 826 postmenopausal women. The additional results announced today showed that after 12 weeks of treatment, the mean scores for common clinical signs of vaginal atrophy were decreased by a statistically significant margin in the Ophena(TM) groups when compared with placebo. These pos
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SOURCE QuatRx Pharmaceuticals Company
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Related medicine technology :

1. QuatRx Initiates Second Phase 3 Study of Ophena(TM) (Ospemifene Tablets) in Women With Postmenopausal Vaginal Syndrome
2. Quatrx Pharmaceuticals Presents Results From Ophena(TM) (Ospemifene Tablets) Phase 3 Study Related to Treatment of Symptoms of Vulvovaginal Atrophy
3. QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena(TM) (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovaginal Atrophy
4. QuatRx Pharmaceuticals Announces Positive Phase 3 Results for Study of Ophena(TM) (ospemifene) to Treat Postmenopausal Vaginal Syndrome
5. QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
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