A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.

Part of paid clinical trials in Berkeley, California.

Sponsor
Reckitt Benckiser Healthcare (UK) Limited
Study ID
NCT06557499
Status
Recruiting
Apply to this trial

Conditions

  • Contraception

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Polyurethane (PU) male condom-Test condom 1 — DEVICE
    A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.
  • Polyurethane (PU) male condom-Test condom 2 — DEVICE
    A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.
  • Natural Rubber Latex (NRL) male condom- Control condom — DEVICE
    A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.

Study Details

This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex (NRL) male condom. The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom (for example, how often the different condom types break or slip off the penis). Sponsor also wants to find out how well couples like using the three condom types and whether they experience any problems when using the condoms (for example, irritation or discomfort).

Key Dates

Start date
Aug 23, 2024
Status verified
Feb 2025
Primary completion
May 19, 2025
Completion
May 19, 2025

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Polyurethane (PU) male condom-Test condom 1
  • Experimental: Polyurethane (PU) male condom-Test condom 2
  • Active Comparator: Natural Rubber Latex (NRL) male condom- Control condom

Primary Outcome Measure

Total clinical failure rate of Polyurethane (PU) male (Test condom 1) condom compared to Natural Rubber Latex (NRL) male condom. [ Time Frame: within 8 hours following each coital act for each condom use ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Essential Access Health-BerkeleyBerkeleyCalifornia90010
Terri Walsh
800-300-5767
Essential Access Health -Los AngelesLos AngelesCalifornia90017
Terri Walsh
[email protected]
888-702-0808
Essential Acess Health- SeattleSeattleWashington98005
Terri Walsh
206-790-7282

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