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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

Results presented at the 90th annual Endocrine Society meeting show significant improvements among women affected by moderate to severe vaginal

dryness and painful intercourse

ANN ARBOR, Mich, June 16 /PRNewswire/ -- QuatRx Pharmaceuticals today announced detailed primary endpoint results from a pivotal Phase 3 clinical trial of Ophena(TM) (ospemifene tablets) to treat postmenopausal women with symptoms of vulvovaginal atrophy, a common condition associated with menopause. The study successfully met all four co-primary endpoints. Women treated with Ophena(TM) at the 60 mg dose showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), 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. Results of this Phase 3 clinical trial were presented today in a poster presentation at the 90th annual Endocrine Society meeting in San Francisco.

The decline in estrogen levels in women after menopause is associated with an increase in vaginal pH levels as well as a thinning of the vaginal wall, resulting in bothersome symptoms such as vaginal dryness and painful intercourse. In the Phase 3 Ophena(TM) clinical study, women were asked to identify their most bothersome symptom of vaginal atrophy. The co-primary endpoints were defined as 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 symptom.

"Vaginal atrophy symptoms in postmenopausal women are usually progressive and, unlike hot flashes, do not resolve spontaneously. They can have a significant impact on a woman's quality of life. These Phase 3 clinical study results indicate that this new oral tablet ha
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SOURCE QuatRx Pharmaceuticals Company
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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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