Dare Bioscience announces publication of data from Phase 1 clinical trial

Dare Bioscience announced that Climacteric, the official journal of the International Menopause Society, published safety and acceptability results from a Phase 1 clinical trial of DARE-HRT1, an investigational ethylene vinyl acetate copolymer intravaginal ring designed to release bio-identical 17beta-estradiol and progesterone over 28 days. DARE-HRT1 is being developed for the treatment of moderate-to-severe vasomotor symptoms, VMS, due to menopause in women with intact uteri. Hormone therapy is used to treat VMS and genitourinary syndrome associated with menopause. DARE-HRT1 has the potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format. The North American Menopause Society’s guidance on hormone therapy states that dosing estrogen and progestogen in combination may offer important benefits to women, and NAMS observed that non-oral routes of administration may offer advantages over orally administered therapies. Approximately 30 healthy, postmenopausal women participated in the open-label, three-arm Phase 1 study. The primary objective of the study was to assess the pharmacokinetics from the two dosage strengths of the DARE-HRT1 IVRs. The secondary objective of the study was to assess the safety of the IVRs while the exploratory objectives were to assess usability and participant tolerability of the IVRs. The study demonstrated that the DARE-HRT1 IVRs, in general, were safe and well tolerated in healthy postmenopausal women and treatment emergent adverse events profiles were comparable between the DARE-HRT1 groups and the reference oral regimen group.