Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom

Eligibility Criteria

• 1. Between the ages of 18 and 45 (inclusive)
• 2. Willing and able to give written or electronic informed consent
• 3. Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews
• 4. Be sexually active (defined as averaging one vaginal coital act per week)
• 5. Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
• 6. Willing to use the study products for ten acts of vaginal intercourse within six weeks of study entry
• 7. In a mutually monogamous relationship with their study partner for at least 3 months and be willing to remain mutually monogamous throughout study participation
• 8. Agree not to use any vaginal or sexual lubricant except the product supplied by the study
• 9. Agree not to wear any genital piercing jewelry while using the study condoms
• 10. Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
• 11. Agree to return any unopened condoms
• 12. Reachable by telephone
• 13. Has home internet access, a valid personal email for each partner, reachable by phone, ability to videoconference and use electronic consent technology
• 14. Male partner agrees to ejaculate during vaginal intercourse
• 15. Willing to provide photo identification-
• 1. Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
• 2. Female partner self-reported as pregnant
• 3. Allergic to natural rubber latex or polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products
• 4. Unable to follow instructions or strictly adhere to the visit schedule
• 5. At significant (high) risk of sexually transmitted infections, including HIV infection, or having a medical history of recurrent, serious sexually transmitted infection (e.g. gonorrhea, syphilis, Chlamydia)
• 6. Currently using condoms for protection against a known sexually transmitted infection
• 7. Taking any internally applied medication or oral medication to treat a genital condition
• 8. Male partner has had difficulty achieving or maintaining an erection, or achieving ejaculation in the last month under typical circumstances/ conditions.
• 9. Any self-reported genital condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data -