Silicone Lubricated Synthetic polyisoprine condom: Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity
Silicone Lubricated Natural Rubber Latex Condom: Natural rubber latex condoms are made from natural rubber
Study summary
This study is a masked (investigators, research staff), two-way crossover, randomized to sequence of use study designed to evaluate the acceptability and functional performance (breakage, slippage) of a silicone lubricated polyisoprene condom and a silicone lubricated natural rubber latex condom.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion 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-
Exclusion Criteria:
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 -
Primary outcome measure(s)
Total Clinical Failure — 5 -7 weeks The total clinical failure rate is defined as the number of condoms that broke or slipped completely off the penis during intercourse or withdrawal over the number of condoms used for vaginal intercourse.
Trial sites (2)
Facility
City
Region
Status
Essential Access
Berkeley
California
Recruiting
Essential Access
Los Angeles
California
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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