Contraceptive Efficacy Study of Ovaprene

Inclusion Criteria:

• Sexually active people assigned female at birth, at risk for pregnancy and desiringcontraception.

• 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 eligibilitycriteria below.

--At least 18 years old, not known to be subfertile or infertile

• Have regular menstrual cycles (when not on hormonal contraception) with a usuallength of 21 to 35 days, without heave bleeding that lasts longer than 5 days

• Be willing to stop their current method of contraception (with the exception ofcondoms) before Visit 2. Participants must experience at least one subsequentmenstrual bleed before inserting Ovaprene. Participants using injectablecontraception must be at least 9 months post their last dose at screening and haveexperienced at least 2 subsequent regular menstrual bleeds that were part of cyclesof 21-35 days. After stopping their current method of contraception, subjects musteither abstain fro vaginal sex or use condoms before inserting their first Ovaprene

• Not be actively desiring pregnancy for at least 13 months and be willing to acceptan unknown risk of pregnancy

• Expect to engage in at least 4 acts of heterosexual vaginal intercourse per cycleduring the study.

• Be willing to only use Ovaprene as the sole method of contraception over the courseof the study

• Agree not to participate in any other clinical trials during the course of the study

• Be willing and able to comply with study procedures and to return to the clinic forscheduled follow-up visits

• Microbiota/innate immunity and colposcopy subsets only:

• Be willing to avoid vaginal sex and using tampons and other intravaginalproducts for 48 hours prior to clinic visits; and be willing to comply withsubset procedures

Exclusion Criteria:

• 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

• Be breastfeeding an infant

• Have a history suggestive of infertility, defined as any of the following: knownhistory of ectopic pregnancy or other fertility problem; sterilization/permanentcontraception; endometriosis or hospitalization for pelvic inflammatory disease (PID) unless subject has had a subsequent spontaneous intrauterine pregnancy; or useof medications that could cause subfertility such as gonadotropin-releasing hormoneagonists

• Currently have postcoital bleeding

• Have contraindications to pregnancy (medical condition) or chronic use ofmedications contraindicated in pregnancy

• Have a history of clinically significant uterine prolapse, cystocele, or rectocelethat has required surgical intervention or pessary use

• Positive human immunodeficiency virus (HIV) test at screening

• Have exclusionary results on human papilloma virus (HPV) screening/cytology (subjects>/=21 years old) at screening or require treatment or follow-up for anabnormal Pap smear or HPV test that would be needed during the study.

• Have had a vaginal or cervical biopsy within 1 month or vaginal surgery within the 3months prior to screening

• Known current drug or alcohol abuse which, in the opinion of the investigator, couldimpact study compliance

• Have previously been included in the Enrolled-Eligible Population

• Is a direct employee or immediate family member of the Sponsor company, siteInvestigators or study staff

• Have taken any investigational drug or used any investigational device within the 30days prior to screening

• Have a history of any severe acute or chronic medical or psychiatric condition orlaboratory abnormality that could increase the risk associated with trialparticipation or study treatment administration or could interfere with theinterpretation of trial results

• Microbiota/innate immunity subset only:

--systemic use in the last 2 weeks prior to screening or anticipated use during thestudy of antibiotics (other than those used to treat urinary tract infection (UTI),candidiasis, or bacterial vaginosis(BV) diagnosed at Visit 1) or antivirals;

• If male partner has or is suspected to have had an HIV infection or other sexuallytransmitted infection

• if male partner has a known sensitivity or allergy to the ingredients in Ovaprene

• If male partner has previously participated in this study or has taken anyinvestigational drug or used any investigational device within 30 days prior to thefemale subject's screening

• If the male partner has a history of any severe acute or chronic medical orpsychiatric condition that could increase the risk associated with trialparticipation or could interfere with the interpretation of trial results.