Phase 3 study of Ophena for postmenopausal vaginal atrophy

QuatRx Pharmaceuticals announced that it has completed enrollment in their second pivotal Phase 3 clinical trial of Ophena (ospemifene) tablets for the treatment of postmenopausal vaginal atrophy. The randomized, double-blind study has enrolled over 900 postmenopausal women at 116 trial centers throughout the United States. Women in the study are being treated with either a 60mg once-daily oral dose of Ophena or placebo over the 12-week 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.  

Ophena, a selective estrogen receptor modulator (SERM), is available as an estrogen-free oral therapy.  

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