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QuatRx Completes Enrollment of Ophena(TM)(Ospemifene Tablets) Final Pivotal Phase 3 Study in Women with Postmenopausal Vaginal Atrophy
Date:3/31/2009

tment period. All women are also being supplied with a non-hormonal vaginal lubricant to be applied as needed during the treatment period. The co-primary endpoints of the study are the change from baseline to week 12 in the percentage of parabasal cells in the vaginal maturation index, the percentage of superficial cells in the vaginal maturation index, vaginal pH, and improvements in the most bothersome moderate to severe vulvovaginal atrophy symptoms of vaginal dryness and dyspareunia.

The study is the second pivotal Phase 3 clinical trial for Ophena(TM), a novel selective estrogen receptor modulator (SERM) for the treatment of vaginal atrophy. Vaginal atrophy is a common condition in postmenopausal women characterized by progressive long-term vaginal symptoms such as dryness, irritation and sexual pain (dyspareunia). The first Phase 3 trial for Ophena(TM) met all the co-primary endpoints at the 60mg dosage, with statistically significant improvements in vaginal dryness and dyspareunia, as well as statistically significant improvement in the proportion of parabasal and superficial cells in the epithelium of vaginal walls and a decline in vaginal pH levels.

About Postmenopausal Vaginal Atrophy

Postmenopausal vaginal atrophy 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 vaginal atrophy. Dryness and irritation associated with reductions in vaginal secretions often cause pain or bleeding during sexual intercourse. It is estimated that 45-75 percent of postmenopausal women experience chronic symptoms of vaginal atrophy which are bothersome in over 90 percent of cases. Current prescription treatments approved for this condition all contain estrogen, administered either orally or
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SOURCE QuatRx Pharmaceuticals
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Related medicine technology :

1. QuatRx Completes Patient Enrollment in Phase 3 Study of Ophena(TM) in Women with Postmenopausal Vaginal Syndrome
2. QuatRx Pharmaceuticals Announces Positive Phase 3 Results for Study of Ophena(TM) (ospemifene) to Treat Postmenopausal Vaginal Syndrome
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 Presents Results From Ophena(TM) (Ospemifene Tablets) Phase 3 Study Related to Treatment of Symptoms of Vulvovaginal Atrophy
5. QuatRx Initiates Second Phase 3 Study of Ophena(TM) (Ospemifene Tablets) in Women With Postmenopausal Vaginal Syndrome
6. QuatRx Pharmaceuticals Announces Additional Data From Phase 3 Study for Ophena(TM) (Ospemifene Tablets) Showing Improvements in Clinical Symptoms of Vulvovaginal Atrophy
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8. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
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