NCT06557499

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

A Randomized, Data Analyst-masked, 3-way Cross-over, Pivotal Clinical Investigation to Evaluate the Performance of Two Polyurethane Male Condoms With Different Size and Thickness in Healthy Monogamous Couples During Vaginal Intercourse Compared With a Commercially Available Thin Latex Male Condom.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

In this clinical investigation, new two PU male condoms (test condoms) will be evaluated against a marketed NRL male condom (control condom). This clinical investigation will also evaluate the in-use tolerance of the test and control condoms.

Conditions

• Contraception

Interventions

Type	Name	Description
DEVICE	Polyurethane (PU) male condom-Test condom 1	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.
DEVICE	Polyurethane (PU) male condom-Test condom 2	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.
DEVICE	Natural Rubber Latex (NRL) male condom- Control condom	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.

Timeline

• Start date: 2024-08-23
• Primary completion: 2025-05-19
• Completion: 2025-05-19
• First posted: 2024-08-16
• Last updated: 2025-02-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study