QuatRx Initiates Second Phase 3 Study of Ophena(TM) (Ospemifene Tablets) in Women With Postmenopausal Vagina...( Pivotal Study Seeks to Enroll 750 Wo...),Health

Pivotal Study Seeks to Enroll 750 Women at More Than 100 Sites in the U.S.

ANN ARBOR, Mich., Sept. 4 /PRNewswire/ -- QuatRx Pharmaceuticals, a privately-held biopharmaceutical company focused on development and commercialization of compounds to treat endocrine, metabolic and cardiovascular disorders, today announced that it has initiated a second Phase 3 clinical trial of Ophena(TM) (ospemifene tablets), the company's estrogen-free oral therapy in development for the treatment of vaginal symptoms associated with menopause.

The study is the second pivotal Phase 3 clinical trial for Ophena(TM), a new selective estrogen receptor modulator (SERM) for the treatment of postmenopausal vaginal syndrome (PVS), a common condition in postmenopausal women. PVS, also known as vaginal atrophy, is 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 a 60 mg 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.

The randomized, double-blind study will seek to enroll 750 post-menopausal women at more than 100 trial centers throughout the United States. Women participating in the study will be treated with either a 60 mg once daily oral dose of Ophena(TM) or placebo over the 12-week treatment period. All women will also be 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
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