Evaluation of the Performance and Acceptability of a Synthetic Polyisoprene Male Condom Compared to a Natural Rubber Latex Condom

NCT06595836 | Recruiting FDA Device

• 1 other identifier: TNR-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Total Clinical Failure

  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.

  5 -7 weeks

Secondary Outcomes (2)

• Clinical Breakage

  5 - 7 weeks

• Clinical Complete Slippage

  5-7 weeks

Study Arms (2)

polyisoprene condoms lubricated with a silicone lubricant

EXPERIMENTAL

polyisoprene condoms lubricated with a silicone lubricant

Device: Silicone Lubricated Synthetic polyisoprine condom

commercial latex condoms with a silicone lubricant

ACTIVE COMPARATOR

commercial latex condoms with a silicone lubricant

Device: Silicone Lubricated Natural Rubber Latex Condom

Interventions

Silicone Lubricated Synthetic polyisoprine condom DEVICE

Synthetic polyisoprene condom are made from softer materials for a more natural feel and increased sensitivity

polyisoprene condoms lubricated with a silicone lubricant

Silicone Lubricated Natural Rubber Latex Condom DEVICE

Natural rubber latex condoms are made from natural rubber

commercial latex condoms with a silicone lubricant

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 -

Sponsors & Collaborators

• Thai Nippon Rubber Industry Public Company Limited: lead

Study Sites (2)

Essential Access

Berkeley, California, 94710, United States

RECRUITING

Essential Access

Los Angeles, California, 90010-2648, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each product will be labeled with a randomly generated code
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: January 2, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (2)