Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom
Recruiting now · Not applicable
Conditions studied: Condom Use
In brief
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.
Key facts
- Study ID
- NCT06595836
- Run by
- Thai Nippon Rubber Industry Public Company Limited
- People needed
- 300
- Starts
- 2024-01-02
- Expected to finish
- 2025-02-28
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Between the ages of 18 and 45 (inclusive)
- Willing and able to give written or electronic informed consent
- Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained either on self-administered questionnaires or interviews
- Be sexually active (defined as averaging one vaginal coital act per week)
- Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
- Willing to use the study products for ten acts of vaginal intercourse within six weeks of study entry
- In a mutually monogamous relationship with their study partner for at least 3 months 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
- Agree not to wear any genital piercing jewelry 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, reachable by phone, ability to videoconference and use electronic consent technology
- Male partner agrees to ejaculate during vaginal intercourse
- Willing to provide photo identification-
You may not qualify if…
- 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 polyisoprene, or has a history of recurrent adverse events following use of latex or polyisoprene products
- Unable to follow instructions or strictly adhere to the visit schedule
- 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)
- Currently using condoms for protection against a known sexually transmitted infection
- Taking any internally 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 under typical circumstances/ conditions.
- 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 it is running
- Essential Access — Berkeley, California, United States (enrolling)
- Essential Access — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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