progesterone intravaginal ring (JNP-0301) / Catalent - LARVOL DELTA

Demonstration of in vitro-in vivo relationship (IVIVR) and virtual bioequivalence (VBE) between progesterone intravaginal rings using physiologically based pharmacokinetic (PBPK) modelling. (PubMed, J Pharm Sci) - "In conclusion, PBPK can support IVIVR development and alternative BE methodologies with reduced human testing. The validated vaginal absorption model described here can also support post approval changes provided the in vitro release of modified formulations falls within the established in vitro dissolution safe space limits of -7.36% and +9.40% mg/day release on day 1, 2 and 7 respectively."

Journal • PK/PD data • Preclinical

Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Daré Bioscience, Inc. | Initiation date: Jun 2025 ➔ Nov 2025

Trial initiation date

Comparing the Pharmacokinetics of a Progesterone Ring Versus a Progesterone Vaginal Insert (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Daré Bioscience, Inc.

New P1 trial

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

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

Pharmacokinetics and tolerability of a novel 17β-estradiol and progesterone intravaginal ring in sheep. (PubMed, J Pharm Sci) - "A novel 2-drug IVR delivery system was well tolerated in a sheep model and pharmacokinetic release was as expected over a 28-day release period. These results will guide future human clinical studies."

Journal • PK/PD data

Pharmacokinetics and tolerability of a novel progesterone intravaginal ring in sheep. (PubMed, Drug Deliv Transl Res) - "Irritation scores and microscopic assessments were consistent with the IVRs being well tolerated. These results will guide future human clinical studies to ultimately develop an IVR for use in women for the prevention of preterm birth."

Journal • PK/PD data