Recruiting

Polyisoprene vs. Latex

Sponsor:

Thai Nippon Rubber Industry Public Company Limited

Code:

NCT06595836

Conditions

Condom Use

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Silicone Lubricated Synthetic polyisoprine condom

Silicone Lubricated Natural Rubber Latex Condom

Study Details

Brief 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.

Conditions

Condom Use

Study ID

NCT06595836

Start date

Jan 2, 2024

Status verified date

Sep, 2024

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

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 -

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: polyisoprene condoms lubricated with a silicone lubricant

polyisoprene condoms lubricated with a silicone lubricant

active comparator: commercial latex condoms with a silicone lubricant

commercial latex condoms with a silicone lubricant

Interventions

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

Primary outcome measure

  • Total Clinical Failure [ Time Frame: 5 -7 weeks ]

Central Contacts and Locations

Locations

Essential Access

Recruiting

Berkeley, California, United States, 94710

Contacts

Principal Investigator:

Terri Walsh, MPH

Essential Access

Recruiting

Los Angeles, California, United States, 90010-2648

Contacts

Principal Investigator:

Terri Walsh, MPH

More Information

Sponsor

Thai Nippon Rubber Industry Public Company Limited

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Thai Nippon Rubber Industry Public Company Limited on 2024-09-19.