The study is the second pivotal Phase III clinical trial for Ophena, a new selective estrogen receptor modulator 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.
The randomized, double-blind study will seek to enroll 750 post-menopausal women at more than 100 trial centers throughout the US. Women participating in the study will be treated with either a 60mg once daily oral dose of Ophena 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 atrophy symptoms of vaginal dryness and dyspareunia.
The first Phase III trial for Ophena met all the co-primary endpoints at a 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.
Robert Zerbe, CEO and president of QuatRx: “We were very pleased with the results of the first Phase III trial for Ophena and believe this next pivotal study will represent another significant development milestone for QuatRx.”