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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

ls (which indicate a well estrogenized effect) as compared to two percent with placebo. The decrease in pH to a more favorable one in the treatment group was also statistically significant as compared to placebo (-1.01 1.1 versus -0.10 0.8). Ophena(TM) was generally well tolerated and demonstrated a favorable safety profile.

Ophena(TM), a novel selective estrogen receptor modulator (SERM), is being studied as a non-estrogen alternative for the treatment of symptoms of postmenopausal vaginal syndrome (PVS), also known as vaginal atrophy. The only FDA approved prescription products currently available to treat PVS contain estrogen. Treatment with estrogen therapy has been associated with certain health risks, and many women prefer non-estrogen alternatives.

"These results provide strong support for our efforts to advance Ophena(TM) through the regulatory review process. Our next Phase 3 trial for Ophena(TM) will begin later this year. We remain committed to completing the necessary clinical studies and regulatory filings in support of Ophena(TM) as quickly as possible to make this non-estrogen treatment option available to the millions of women affected by vulvovaginal atrophy around the world" added Robert Zerbe, M.D.

About Postmenopausal Vaginal Syndrome

Postmenopausal vaginal syndrome (PVS) is a chronic and progressive condition characterized by symptoms including vaginal dryness, sexual pain (dyspareunia) and irritation. Declining estrogen levels during menopause can cause tissues of the vaginal lining to grow thinner and to lose elasticity, a condition known as atrophy. Dryness and irritation associated with reductions in vaginal secretions often cause pain or bleeding during sexual intercourse. It is estimated that up to 45-75 percent of post-menopausal women have chronic symptoms of PVS. Current prescription treatments approved for this condition all contain estrogen, administered either orally or locally in the vagina. SERMs that
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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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