estrogen/progesterone intravaginal ring (DARE-HRT1) / Daré Biosci, Catalent - LARVOL DELTA

A phase 1/2, open-label, parallel group study to evaluate the preliminary efficacy and usability DARE-HRT1 (80 μg estradiol/4 mg progesterone and 160 μg estradiol/8 mg progesterone intravaginal RinGSM) over 12 weeks in healthy postmenopausal women. (PubMed, Menopause) - "Data from this study support further development of DARE-HRT1 for the treatment of menopausal symptoms."

Journal • P1/2 data • P2 data • Women's Health

Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women (clinicaltrials.gov) - P1/2 | N=21 | Completed | Sponsor: Daré Bioscience, Inc. | Active, not recruiting ➔ Completed

Trial completion • Solid Tumor • Vaginal Atrophy • Women's Health

A phase 1/2, open-label, parallel group study to evaluate the safety and pharmacokinetics of DARE-HRT1 (80 μg estradiol/4 mg progesterone and 160 μg estradiol/8 mg progesterone intravaginal rings) over 12 weeks in healthy postmenopausal women. (PubMed, Menopause) - "Both DARE-HRT1 IVRs were safe and released E2 in systemic concentrations, which were in the low, normal premenopausal range. Systemic P4 concentrations predict endometrial protection. Data from this study support further development of DARE-HRT1 for the treatment of menopausal symptoms."

Journal • P1/2 data • PK/PD data

Safety and acceptability of intravaginal rings releasing estradiol and progesterone. (PubMed, Climacteric) - "DARE HRT1-001 was the first-in-woman study of 28-day exposure to two 28-day intravaginal rings (IVRs) designed to release 80 µg/day E2 + 4 mg/day P4 (IVR1) or 160 µg/day E2 + 8 mg/day P4 (IVR2) compared with oral E2 1 mg/day + oral P4 100 mg/day. Both IVR1 and IVR2 were safe and well tolerated in healthy postmenopausal women. TEAE profiles were comparable to the referent oral regimen."

Journal • Endometriosis • Oncology • Women's Health

Evaluation of 28-day estradiol and progesterone vaginal rings in a phase 1 clinical pharmacokinetic study. (PubMed, Menopause) - "The 80/4 IVR and 160/8 IVR gave similar steady-state concentrations of E2 as seen with drug products approved by the US Food and Drug Administration for treatment of VMS and genitourinary symptoms of menopause. The E2 concentrations of this study support the potential of DARE-HRT1, a promising new option for hormone therapy for treatment of VMS and vaginal symptoms associated with menopause."

Journal • P1 data • PK/PD data • Women's Health

A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Daré Bioscience, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Jan 2022

Trial completion • Trial completion date • Vaginal Atrophy • Women's Health

Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women (clinicaltrials.gov) - P1/2 | N=21 | Active, not recruiting | Sponsor: Daré Bioscience, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Mar 2023

Enrollment closed • Trial completion date • Solid Tumor • Vaginal Atrophy • Women's Health

A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Daré Bioscience, Inc.

New P1 trial • Vaginal Atrophy • Women's Health

Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Daré Bioscience, Inc.

New P1/2 trial • Cervical Cancer • Solid Tumor • Vaginal Atrophy • Women's Health