TX-004HR is an investigational bio-identical estradiol softgel capsule that can be administered vaginally without the need for an applicator.
The pivotal safety and efficacy Rejoice trial is a randomized, multicenter, double-blind, placebo-controlled study evaluating three strengths of TX-004HR – 4mcg, a new low-dose option; 10mcg and 25mcg.
The 12-week trial enrolled more than 700 participants in approximately 100 sites across the US and Canada.
The Rejoice trial seeks to evaluate multiple doses of an investigational, applicator-free vaginal estradiol for the treatment of pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
The trial is also collecting efficacy data on vaginal dryness, and vaginal and/or vulvar itching or burning.
TherapeuticsMD chief medical officer Dr Sebastian Mirkin said: "Recent studies have shown that current therapies used to treat VVA generate some concerns from women with respect to their efficacy, convenience and safety.
"TX-004HR was designed to try to address these unmet needs. Completion of patient recruitment in the Rejoice Trial marks an important milestone in our development efforts and we look forward to disclosing topline results from the Rejoice Trial later this year."
VVA is a chronic condition that occurs due to decrease in naturally occurring estrogen during menopause, which results in thinning of the vaginal lining and an increase in vaginal pH levels.
An estimated 32 million women in the US are currently suffering from symptoms of VVA, and only 2.3 million (7%) are currently being treated with prescription therapy.