A Phase 3 Rejoice Trial of TX-004HR (estradiol) to treat moderate to severe dyspareunia (vaginal pain during sexual intercourse), has had positive top-line results. Dyspareunia is a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The announcement of the successful Phase 3 trial was made by TherapeuticsMD, a women’s healthcare company.
The Rejoice Trial was a randomized, double-blind, placebo-controlled, multicenter Phase 3 clinical trial. It compared a placebo to three doses of TX-004HR for the treatment of moderate to severe dyspareunia in postmenopausal women with VVA. Patients received either TX-004HR 25mcg (n=190), 10mcg (n=191), or 4mcg (n=191) doses or placebo (n=192) for a total of 12 weeks. The pre-specified four co-primary efficacy endpoints were the change from baseline to week 12 in the percentage of vaginal superficial cells, percentage of vaginal parabasal cells, vaginal pH, and severity of dyspareunia.
Researchers found that the 25mcg and 10mcg doses of TX-004HR demonstrated highly statistically significant results across all four co-primary endpoints vs. placebo (P≤0.0001). Compared to placebo, the 4mcg dose also demonstrated highly statistically significant results for the endpoints of vaginal superficial cells, vaginal parabasal cells, and vaginal pH (P≤0.0001), while the change from baseline in the severity of dyspareunia was statistically significant (P=0.0255).
Further analyses of the Rejoice Trial data are ongoing. TherapeuticsMD intends to submit detailed results for presentation at future scientific meetings and journal publications.
TX-004HR is an investigational, bio-identical 17β-estradiol vaginal drug product candidate that utilizes a unique applicator-free vaginal estradiol softgel capsule technology, SYMBODA.
For more information call (800) 266-6476 or visit Therapeuticsmd.com.