Comparing a synthetic polyisoprene condom to a natural rubber latex condom
Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom (Phase II Slippage/Breakage Study)
This study is testing whether a new synthetic condom works better and feels better for couples compared to a traditional latex condom.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Thai Nippon Rubber Industry Public Company Limited Industry-sponsored |
| Locations | 2 sites (Berkeley, California and 1 other locations) |
| Trial ID | NCT06595836 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance and acceptability of a silicone lubricated polyisoprene male condom compared to a silicone lubricated natural rubber latex condom. Three hundred couples will participate, using both types of condoms in a randomized sequence to assess their experiences. The study focuses on measuring breakage, slippage, and user acceptability through questionnaires and interviews. The goal is to determine which condom type offers better safety and satisfaction for users.
Who should consider this trial
Good fit: Ideal candidates are sexually active couples aged 18 to 45 who are in a mutually monogamous relationship and willing to use the study condoms.
Not a fit: Patients who are not sexually active or do not use condoms for contraception may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved condom options that enhance user satisfaction and safety.
How similar studies have performed: Previous studies have explored condom performance, but this specific comparison of synthetic polyisoprene to natural rubber latex is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 -
Where this trial is running
Berkeley, California and 1 other locations
- Essential Access — Berkeley, California, United States (Recruiting)
- Essential Access — Los Angeles, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.