Ovaprene® is a monthly non-hormonal intravaginal contraceptive. It is designed to reside in the vagina, covering the external os of the cervix. It consists of a slim, flexible silicone vaginal ring with an incorporated purple multilayer knitted polymer matrix insert. It is a single size “ one size fits most” contraceptive product with a diameter of 55 mm. The product is inserted at the end of menses and removed at the onset of the next menses. A new Ovaprene is inserted at the end of that menses. Your participation in the study would last approximately 12-15 months. During this time, you and your partner would rely on the vaginal disk as your only method of contraception. The vaginal disk, called Ovaprene, is a round piece of woven material surrounded by a soft, flexible rubber ring. The material in the vaginal disk is released slowly to create an environment that makes it difficult for sperm to be mobile. The ring is ferrous gluconate (a type of iron), Vitamin C, glycine, and polyglycolide. Ovaprene is an experimental device, which means that it has not been approved by the Food and Drug Administration (FDA). This is the process that products like this go through when they are seeking FDA approval. There are approximately 8 in-person visits and 2 phone calls. You will also complete a daily diary in which you will answer a couple of very quick questions. If you are eligible and complete every part of the study, you will be compensated up to $1614 total for your time, transportation costs, and daily diary completion.

Healthy Assigned female at birth Between 18-40 years old Inclusion Criteria: 1. Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception 2. General good health, by subject history and per investigator judgment 3. Age 18 through 40 years, inclusive; approximately 66 subjects >35 years old at Visit 2 will be included in the Enrolled-Eligible Population 4. In a relationship with a person assigned male at birth who meets eligibility criteria below 5. Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days, without heavy bleeding that lasts longer than 5 days 6. Be willing to stop their current method of contraception (with the exception of condoms) before Visit 2. 7. Not be actively desiring pregnancy for at least 13 months and be willing to accept an unknown risk of pregnancy 8. Expect to engage in at least 4 acts of penovaginal intercourse per cycle during the study 9. Be willing to only use Ovaprene as the sole method of contraception over the course of the study 10. Agree not to participate in any other clinical trials during the course of the study 11. Be willing and able to comply with study procedures and to return to the clinic for scheduled follow-up visits Subjects will be eligible to be included in the Enrolled-Eligible Population if all of the following conditions exist for their male partner (as reported by the female subject): 1. At least 18 years old 2. Not known to be subfertile or infertile 3. Willing to only use Ovaprene as the sole method of contraception when having vaginal intercourse with the female subject over the course of the study 4. Expect to engage in at least 4 acts of penovaginal intercourse per cycle with the female subject during the study Exclusion Criteria: 1. Currently pregnant and/or have a positive urine pregnancy test at screening 2. Have an allergy to the ingredients in Ovaprene 3. Have a history of toxic shock syndrome (TSS) 4. Have a history of hereditary hemochromatosis 5. Be breastfeeding an infant 6. Have a history suggestive of infertility 7. Currently have post coital bleeding 8. Have contraindications to pregnancy (medical condition) or chronic use of medications with absolute contraindications in pregnancy Have a history of clinically significant uterine prolapse, cystocele, or rectocele that has required surgical intervention or pessary use 10. Positive HIV test at screening 11. Have exclusionary results on HPV screening/cytology (subjects >21 years old) at screening or require treatment or follow-up for an abnormal Pap smear or HPV test that would be needed during the study 12. Have had a vaginal or cervical biopsy within 1 month or vaginal surgery within the 3 months prior to screening 13. Known current drug or alcohol abuse which, in the opinion of the investigator, could impact study compliance 14. Have taken any investigational drug or used any investigational device within the 30 days prior to screening 15. Have a history of any severe acute or chronic medical or psychiatric condition

More information available at ClinicalTrials.gov: NCT06127199