Contraceptive Efficacy Study of Ovaprene

Exclusion Criteria23

• 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: known history of ectopic pregnancy or other fertility problem; sterilization/permanent contraception; endometriosis or hospitalization for pelvic inflammatory disease (PID) unless subject has had a subsequent spontaneous intrauterine pregnancy; or use of medications that could cause subfertility such as gonadotropin-releasing hormone agonists
• Currently have postcoital bleeding
• Have contraindications to pregnancy (medical condition) or chronic use of medications contraindicated in pregnancy
• Have a history of clinically significant uterine prolapse, cystocele, or rectocele that 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 an abnormal 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 3 months prior to screening
• Known current drug or alcohol abuse which, in the opinion of the investigator, could impact study compliance
• Have previously been included in the Enrolled-Eligible Population
• Is a direct employee or immediate family member of the Sponsor company, site Investigators or study staff
• Have taken any investigational drug or used any investigational device within the 30 days prior to screening
• Have a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results
• Microbiota/innate immunity subset only:
• systemic use in the last 2 weeks prior to screening or anticipated use during the study 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 sexually transmitted 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 any investigational drug or used any investigational device within 30 days prior to the female subject's screening
• If the male partner has a history of any severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or could interfere with the interpretation of trial results.