- Daré Bioscience Inc DARE announced topline PK results from its Phase 1 / 2 trial 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 an HT regimen.
- HT treats vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause.
- The levels of estradiol released from the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved or exceeded the levels targeted for hormone therapy.
- Related: Daré Bioscience's Intravaginal Ring Improves Vasomotor, Vaginal Symptoms Of Menopause.
- The levels of progesterone released from both versions of DARE-HRT1 evaluated in the study met the objectives of releasing progesterone.
- Estradiol levels released from the lower and higher dose formulation of DARE-HRT1 evaluated in the study achieved statistically significant improvement in VMS and the genitourinary symptoms of menopause and vaginal pH and maturation index.
- Menopausal symptoms, including hot flashes and night sweats, were reduced compared with baseline in both DARE-HRT1 dose groups.
- Participants also showed significant improvement from baseline in all measures surveyed on The Menopausal Quality of Life Survey.
- The study treatment was well tolerated.
- Daré intends to seek FDA approval of DARE-HRT1 for moderate to severe VMS due to menopause in women with intact uteri.
- Price Action: DARE shares are up 3.20% at $1.01 on the last check Monday.
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