Synthetic Male Condom Slippage-Breakage Study

This is an interventional prevention trial for Contraceptive focused on measuring Synthetic Male Condom, Slippage-Breakage Study, ISO 29943-1 Read More

Inclusion Criteria:

• Willing and able to give written or electronic informed consent
• Willing to respond to questions concerning participant's reproductive and contraceptive history and use of condoms contained either on self-administered surveys or interviews
• Agree to have vaginal intercourse at least once weekly
• Protected against pregnancy by oral contraceptives, an intrauterine device (IUD), an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
• Willing to use the study products for eight acts of vaginal intercourse within four weeks of study entry
• In a mutually monogamous relationship with participant's study partner for at least 3 months prior to screening and be willing to remain mutually monogamous throughout study participation
• Agree not to use any vaginal or sexual lubricant except the product supplied by the study (AstroglideTM)
• Agree not to wear any genital piercing jewellery while using the study condoms
• Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms
• Agree to return any unopened condoms
• Reachable by telephone
• Has home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
• Male partner agrees to ejaculate during vaginal intercourse

Exclusion Criteria:

• Currently participating in another similar clinical study or employed by a condom manufacturer or Essential Access Health
• Female partner self-reported as pregnant
• Allergic to natural rubber latex or styrene-isoprene-styrene (SIS), or has a history of recurrent adverse events following use of latex or SIS products
• Unable to follow instructions or strictly adhere to the visit schedule
• At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus (HIV) infection or having a medical history of recurrent, serious sexually transmitted infection (e.g., gonorrhea, syphilis, Chlamydia)
• Currently using condoms for protection against a known sexually transmitted infection
• Taking any externally applied medication or oral medication to treat a genital condition
• Male partner has had difficulty achieving or maintaining an erection or achieving ejaculation in the last month prior to screening under typical circumstances/ conditions.
• Any self-reported genital condition (e.g., itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect the use of the study condoms or the ability to interpret study data