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Daré Bioscience Announces Initiation of Phase 1 Clinical Trial of DARE-HRT1, a Novel Intravaginal Ring Designed to Deliver Non-oral, Bio-identical Hormone Therapy for the Treatment of Menopausal Symptoms
More than 45 million women in the U.S. are approaching or in menopause SAN DIEGO, July 27, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"More than 45 million women in the U.S. are approaching or in menopause\nSAN DIEGO, July 27, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced the initiation of a Phase 1 clinical trial of DARE-HRT1.\n DARE-HRT1 is designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period and is being developed as a potential new option for hormone therapy (HT) for the treatment of vasomotor symptoms, commonly called hot-flashes, and the genitourinary syndrome of menopause to prevent bone loss and fracture associated with menopause. The North American Menopause Society (NAMS) hormone therapy position statement supports the use of HT in peri- and post-menopausal women, recommends administering both estrogen to reduce symptoms and progesterone to prevent thickening of the uterine wall and observes that non-oral routes of administration may offer advantages over orally administered therapies.1 DARE-HRT1 has the potential to be the first FDA-approved intravaginal ring (IVR) product to meet these NAMS guidelines. “We believe this study will provide important scientific information for both DARE-HRT1 and DARE-FRT1, two of our development-stage programs, given that they both utilize the same IVR technology and bio-identical progesterone as an active ingredient,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “Specifically, this Phase 1 study of DARE-HRT1 will evaluate the ability of DARE-HRT1 to achieve its target dual release objectives, as well as the ability of the IVR technology to release two different active drugs at two different rates. In addition, we anticipate collecting useful pharmacokinetics characteristics of the bio-identical progesterone alone, which can be expected to directly apply to DARE-FRT1, a bio-identical progesterone-only IVR being developed for luteal phase support as part of an invitro fertilization regimen and as a more convenient treatment option for prevention of pre-term birth.” The randomized Phase 1 study will evaluate the pharmacokinetics (PK) of DARE-HRT1 in approximately 30 healthy, post-menopausal women. The primary objective of the study is to describe the PK parameters over 28 days of two different dose combinations of DARE-HRT1. Secondary endpoints of the study include ass...