Contraceptive Efficacy Study of Ovaprene
ConditionContraception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorDaré Bioscience, Inc.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Currently pregnant and/or have a positive urine pregnancy test at screening.
Have an allergy to the ingredients in Ovaprene
Have a history of toxic shock syndrome
Have a history of hereditary hemochromatosis
Trial design
Treatments tested in this trial
- Ovaprene
Treatment groups
656 Participants
are divided into 1 treatment groupSponsors and collaborators
Daré Bioscience, Inc.
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov