NCT05418426

A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women

A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 (80μg Estradiol/4mg Progesterone and 160μg Estradiol/8mg Progesterone Intravaginal Rings) in Healthy PostMenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Daré Bioscience, Inc. · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

An open-label study to assess the PK of estradiol, estrone and progesterone from the DARE-HRT1 intravaginal rings at two different dose strengths.

Conditions

• Vulvovaginal Atrophy
• Vasomotor Symptoms

Interventions

Type	Name	Description
DEVICE	IVR Dose 1	Estradiol 80 ug/progesterone 4 mg
DEVICE	IVR Dose 2	Estradiol 160ug/progesterone 8 mg
DRUG	Oral Reference	estradiol 1mg/progesterone 100 mg

Timeline

• Start date: 2020-08-18
• Primary completion: 2021-04-27
• Completion: 2022-01-27
• First posted: 2022-06-14
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

2 sites across 1 country: Australia