BOSTON — Results from the double-blind, randomized, phase 3 REJOICE clinical trial showed that TX-004HR appeared to alleviate the symptoms of vulvar and vaginal atrophy in menopausal women.
TX-004HR is a novel, low-dose vaginal estrogen capsule containing 17β-estradiol and manufactured by TherapeuticsMD. The company plans to submit the results of this trial to the FDA later this year as part of its new drug application.
“This study provides a new easy-to-use option for vulvar and vaginal atrophy, for which only about 7% of women are currently treated with a prescription product,” lead author Ginger D. Constantine, MD, president and CEO of EndoRheum Consultant, said in a press release. “Health care providers and their patients may soon have an additional safe and effective product for a very untreated condition.”
The data were presented at ENDO 2016.
Vulvar and vaginal atrophy affects about 32 million postmenopausal women in the United States, roughly half of the postmenopausal population. The condition is characterized by decreased estrogenization of vaginal tissue and can cause painful sexual activity and urination, and vaginal dryness, itching, and irritation.
In the trial, 764 postmenopausal women aged 40 to 75 were assigned to vaginal softgel capsules containing 4 mcg, 10 mcg, or 25 mcg of TX-004HR or placebo. Participants received treatment once daily for 2 weeks, then twice weekly for 10 weeks.
At 2 weeks, women in the TX-004HR groups saw significant improvement in vaginal cells and vaginal pH significantly compared with placebo.
At every time point, the return to premenopausal cell ratios was significant, and researchers found superficial and parabasal vaginal cell improvement at baseline and at 2, 6, 8, and 12 weeks. Vaginal pH returned to premenopausal levels as well in the investigational groups, and dyspareunia, vaginal dryness, and irritation were all significantly improved compared with placebo.
On average, TX-004HR did not increase blood levels of estradiol outside the normal postmenopausal range.
Researchers reported no treatment-related serious adverse events, or clinically significant differences in any adverse events or treatment-related serious adverse events between TX-004HR and placebo.
TherapeuticsMD sponsored and supported this study.
- Constantine GD, Simon JA, PIckar JH, et al. LBSAT-12. The Rejoice Trial: A Phase 3 Randomized Controlled Trial Evaluating the Safety and Efficacy of a Novel Vaginal Estradiol Softgel Capsule for Symptomatic Vulvar and Vaginal Atrophy. Presented at: ENDO 2016; April 1-4, 2016; Boston, MA.