TITLE SAGCS2 Protocol 2.3 + Amend 1
Contraception, Prevention of Sexually Transmitted Infections
About this trial
This is an interventional prevention trial for Contraception
Eligibility Criteria
Inclusion Criteria: Between the ages of 18 and 45 (inclusive) Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy) Have home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology Willing and able to give electronic informed consent Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms via interview or self-administered questionnaires Have vaginal intercourse at least once weekly Willing to use the study products for fifteen acts of vaginal intercourse within nine weeks of study entry 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 Both study partners have previous experience using male condoms Agree not to use any additional vaginal or sexual lubricant except the AstroglideTM product provided, if desired, supplied by the study Agree not to expose the study condoms to jewelry (hand, facial, or genital) or piercings (facial or genital) that could damage the study condoms. Agree not to use sex toys or drugs intended to enhance or diminish sexual response when using study condoms Male partner agrees to ejaculate during vaginal intercourse Agree to (or partner) hold the condom at the base of the erect penis during withdrawal Agree to return any condoms that break during use Agree to return any unopened condoms Reachable by telephone Exclusion Criteria: Currently participating in another similar clinical study Female partner self-reported as pregnant Allergic to natural rubber latex or polyurethane, or has a history of recurrent adverse events following use of latex or polyurethane products Unable to follow study requirements, use instructions or attend study visits or exchanges Have a significant (high) risk of STIs, including HIV infection, or having a medical history of recurrent, uncontrolled STIs (e.g. gonorrhoea, syphilis, Chlamydia, etc.) Currently using condoms for protection against a known STI Taking any internally applied medication to treat a genital condition that could interact with the study condom Male partner has used medication that has caused erectile dysfunction, or had difficulty achieving/maintaining an erection, or achieving ejaculation in the last month under typical circumstances/conditions Male has had a prostatectomy 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 or the ability to interpret study data Employee or affiliate of Essential Access Health or Sagami Rubber Industries Co., Ltd.
Sites / Locations
- Essential Access Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control Latex Condom C
Polyurethane Condom A
Polyurethane Condom B
Commercial Natural Rubber Latex Male Condom
Polyurethane Condom A (002)
Polyurethane Condom B (001)