Daré Bioscience has announced the publication of data from a Phase 1/2 clinical trial in Menopause: The Journal of The North American Menopause Society. The study evaluated the safety and pharmacokinetics of DARE-HRT1, an investigational intravaginal ring designed to release bio-identical estrogen and progestogen hormone therapy continuously over a 28-day period as part of a hormone therapy regimen. Daré plans to advance DARE-HRT1 into a single Phase 3 efficacy trial for the treatment of vasomotor symptoms due to menopause.
DARE-HRT1 has the potential to be the first FDA-approved monthly intravaginal ring delivering both estrogen and progestogen hormone therapy. The study enrolled a total of 21 subjects who were randomized (1:1) to receive one of two versions of DARE-HRT1 and used it over 12 weeks (three 28-day cycles). Data from the study support continued clinical development of DARE-HRT1 for the treatment of menopausal symptoms.
Daré Bioscience has published results from its phase