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news.TherapeuticsMD, a US-based women’s healthcare firm, has started patient enrollment in its Phase III clinical trial of TX-004HR (VagiCap) to treat painful intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause.
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VVA results from the decrease in naturally occurring estrogen during menopause, resulting in thinning of the vaginal lining and an increase in vaginal pH levels.
The Phase III Rejoice trial is designed to evaluate multiple doses of TX-004HR, an investigational, applicator-free estradiol as well as also collect data on vaginal dryness, itching and irritation for future evaluation.
Based on the company’s SYMBODA technology, the TX-004HR bio-identical estradiol softgel capsule is administered vaginally without the need for an applicator.
TherapeuticsMD CEO Robert Finizio said the company is happy to meet it s goal to initiate the pivotal, phase III study this quarter, evaluating a new, potentially lower dose estradiol treatment option for women who suffer from dyspareunia associated with VVA.
"We are committed to leveraging our proprietary technology and developing alternatives that further our mission to bring improved hormone therapies to women," Finizio said.
The randomised, double-blind, placebo-controlled trial evaluated three doses of TX-004HR in dosing levels of 25mcg, 10mcg and 4mcg, a potentially new low-dose option.
Around 700 patients are expected to be enrolled in the 12-week trial at about 100 sites across the US.