A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene
Daré Bioscience, Inc.
Summary
This will be a multi-center, single arm, open-label study of Ovaprene, a non-hormonal intravaginal ring, to investigate the contraceptive effectiveness, safety and acceptability of Ovaprene.
Eligibility
- Age range
- 18–40 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception. * General good health, by subject history and per investigator judgement * Age 18 through 40 years, inclusive; approximately 66 subjects \>35 years old at visit 2 will be the Enrolled-Eligible Population * In a relationship with a person assigned male at birth who meets eligibility criteria below. --At least 18 years old, not known to be subfertile or infertile * Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days, with…
Interventions
- DeviceOvaprene
Non-hormonal intravaginal ring
Locations (27)
- Precision Trials AZPhoenix, Arizona
- MomDoc Women's Health ResearchScottsdale, Arizona
- Del Sol Research Management, LLCTucson, Arizona
- Essential Health Access (Berkeley)Berkeley, California
- Essential Access HealthLos Angeles, California
- Amicis Research CenterNewhall, California