Phase 3 Trial Reports Effectiveness of New Low-Dose Vaginal Estrogen Capsule

Results from a new study slated for presentation last weekend at the annual meeting of the Endocrine Society, ENDO 2016, suggest that a low-dose vaginal estrogen capsule, TX-004HR, may relieve symptoms of menopausal vulvar and vaginal atrophy, including dyspareunia. About 50% of postmenopausal women are affected by vulvar and vaginal atrophy, involving decreased estrogenization of vaginal tissue. The condition causes pain with both sexual activity and urination, as well as vaginal dryness, irritation and itching. According to study consultant and lead author Ginger D. Constantine, MD, president and CEO of EndoRheum Consultants, LLC, Malvern, PA, only about 7% of women are currently being treated for their condition with a prescription product. “This study provides a new easy-to-use option for vulvar and vaginal atrophy,” she said. Health care providers and their patients may soon have an additional safe and effective product for a very untreated condition.”

TX-004HR is manufactured by TherapeuticsMD who sponsored the research. It is an investigational drug for use in clinical trials, and not yet available generally. The research consisted of a double-blind, randomized, phase 3 REJOICE clinical trial in which 4, 10, and 25 microgram doses of TX-004HR were compared to placebo in 764 postmenopausal women aged 40-75 years. At all dose levels, improvement in vaginal pH, and dyspareunia, vaginal dryness, and irritation was noted within 2 weeks, compared to placebo. The manufacturer plans to submit its new drug application for approval of TX-004HR to the FDA this year. Read more about the findings here.


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