Promising Results in Phase 3 Trial for Novel Estradiol Softgel

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.

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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.

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