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RECRUITING
NCT06557499
NA

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

Sponsor: Reckitt Benckiser Healthcare (UK) Limited

View on ClinicalTrials.gov

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).

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-08-23

Completion Date

2025-05-19

Last Updated

2025-02-18

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (3)

Essential Access Health-Berkeley

Berkeley, California, United States

Essential Access Health -Los Angeles

Los Angeles, California, United States

Essential Acess Health- Seattle

Seattle, Washington, United States