TITLE SAGCS2 Protocol 2.3 + Amend 1

Inclusion Criteria:

1. Between the ages of 18 and 45 (inclusive)
2. Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptiveinjections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
3. Have home internet access, a valid personal email for each partner, ability tovideoconference and use electronic signature technology
4. Willing and able to give electronic informed consent
5. Willing to respond to questions concerning their reproductive and contraceptivehistory and use of condoms via interview or self-administered questionnaires
6. Have vaginal intercourse at least once weekly
7. Willing to use the study products for fifteen acts of vaginal intercourse within nineweeks of study entry
8. In a mutually exclusive monogamous relationship with their study partner for at least 6 months and be willing to remain mutually monogamous throughout study participation
9. Both study partners have previous experience using male condoms
10. Agree not to use any additional vaginal or sexual lubricant except the AstroglideTMproduct provided, if desired, supplied by the study
11. Agree not to expose the study condoms to jewelry (hand, facial, or genital) orpiercings (facial or genital) that could damage the study condoms.
12. Agree not to use sex toys or drugs intended to enhance or diminish sexual responsewhen using study condoms
13. Male partner agrees to ejaculate during vaginal intercourse
14. Agree to (or partner) hold the condom at the base of the erect penis during withdrawal
15. Agree to return any condoms that break during use
16. Agree to return any unopened condoms
17. Reachable by telephone

Exclusion Criteria:

1. Currently participating in another similar clinical study
2. Female partner self-reported as pregnant
3. Allergic to natural rubber latex or polyurethane, or has a history of recurrentadverse events following use of latex or polyurethane products
4. Unable to follow study requirements, use instructions or attend study visits orexchanges
5. Have a significant (high) risk of STIs, including HIV infection, or having a medicalhistory of recurrent, uncontrolled STIs (e.g. gonorrhoea, syphilis, Chlamydia, etc.)
6. Currently using condoms for protection against a known STI
7. Taking any internally applied medication to treat a genital condition that couldinteract with the study condom
8. Male partner has used medication that has caused erectile dysfunction, or haddifficulty achieving/maintaining an erection, or achieving ejaculation in the lastmonth under typical circumstances/conditions
9. Male has had a prostatectomy
10. Any self-reported genitourinary condition (e.g. itching, burning, irritation, etc.)which, in the opinion of the investigator, could affect use of the study condoms orthe ability to interpret study data
11. Employee or affiliate of Essential Access Health or Sagami Rubber Industries Co., Ltd.