Daré Bioscience Announces Publication in Menopause: The Journal of The North American Menopause Society of Data from Phase 1 Trial of DARE-HRT1 that Support the Potential of DARE-HRT1 as an Effective Hormone Therapy for both Vasomotor and Vaginal Symptom
SAN DIEGO, Jan. 26, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the publication of data from a Phase 1 trial evaluating the pharmacokinetics of DARE-HRT1, an investigational intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy regimen, in the journal Menopause, which is the journal of the North American Menopause Society. Daré previously reported positive topline results from this study, as well as from a subsequent Phase 1 / 2 clinical trial of DARE-HRT1. The journal article entitled “Evaluation of 28-Day Estradiol and Progesterone Vaginal Rings in a Phase 1 Clinical Pharmacokinetic Study” is available at the Menopause journal’s website in the Latest Articles section.
- Daré previously reported positive topline results from this study, as well as from a subsequent Phase 1 / 2 clinical trial of DARE-HRT1.
- Hormone therapy is used to treat the vasomotor symptoms (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.
- Ongoing activities to support progressing directly into a single Phase 3 study to support registration include manufacturing and non-clinical studies to support the IND submission and the planned IND-opening Phase 3 study.