A Single-Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene
Ovaprene Non-Hormonal Contraceptive Ring Study
Sponsor: NIH
Enrolling: Female Patients Only
Study Length: 13 Months
IRB Number: AAAU9840
U.S. Govt. ID: NCT06127199
Contact: Ayda Oktem: 212-305-8031 / ao2845@cumc.columbia.edu
Additional Study Information: Ovaprene, is an experimental monthly non-hormonal intravaginal contraceptive being developed as a possible new method of birth control. It consists of a round piece of woven material surrounded by a soft, flexible rubber ring. The ring itself is made of a silicone rubber combined with the following ingredients: ferrous gluconate (a type of iron), Vitamin C, glycine and polyglycolide microparticles (a slowly dissolving compound). The materials in the study ring are slowly released during the woman's cycle to create an environment that makes it more difficult for sperm to be mobile. The study device is inserted at the end of a women's period and worn until the start of her next period. It is not yet known how well this new contraceptive study ring will work to prevent a woman from becoming pregnant. This device is designed to provide continuous birth control for the woman between her periods. Ovaprene is an experimental device which means that it is still in the research phase of development and has not been approved by the Food and Drug Administration (FDA). You may qualify if: Assigned female at birth, sexually active, aged 18-40, have regular menstrual cycles, willing to stop your current method of contraception, and in general good health.
Paula Castano, MD, MPH
Do You Qualify?
Are you currently sexually active? Yes No
Do you have regular menstrual cycles? Yes No
If enrolled in the study, are you willing to stop your current method of contraception? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Ayda Oktem