A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.
NCT Number: NCT06557499
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Contraception
Interventions: DEVICE: Polyurethane (PU) male condom-Test condom 1|DEVICE: Polyurethane (PU) male condom-Test condom 2|DEVICE: Natural Rubber Latex (NRL) male condom- Control condom
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Collaborators: Novotech (Australia) Pty Limited
Sex: ALL
Age: ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-23
Completion Date: 2025-05-19
Locations: Essential Access Health-Berkeley, Berkeley, California, 90010, United States|Essential Access Health -Los Angeles, Los Angeles, California, 90010, United States|Essential Acess Health- Seattle, Seattle, Washington, 98005, United States

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).

Primary Outcome Measures: Total clinical failure rate of Polyurethane (PU) male (Test condom 1) condom compared to Natural Rubber Latex (NRL) male condom., The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 1) compared to the NRL male control condom.

Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by participants., within 8 hours following each coital act for each condom use|Total clinical failure rate of Polyurethane (PU) male (Test condom 2) condom compared to Natural Rubber Latex (NRL) male condom., The total clinical failure rate (combined breakage and slippage) of PU male test condom (Test condom 2) compared to the NRL male control condom.

Clinical failure rate is calculated as the number of condoms with at least 1 acute clinical failure event divided by the number of condoms used during intercourse, reported as a percentage. Clinical failure events, defined in ISO 29943-1:2017, will be reported by participants., within 8 hours following each coital act for each condom use
Secondary Outcome Measures: Clinical breakage rate of PU Male Test Condom 1 compared to NRL male control condom, The total clinical breakage rate of the PU male test condom (Test condom 1) compared to the NRL male control condom when used during vaginal intercourse.

The total clinical breakage rate is determined from the number of condoms broken or torn during vaginal intercourse or withdrawal from the vagina divided by the number of condoms used during intercourse, reported as a percentage., within 8 hours following each coital act for each condom use|Clinical slippage rate of PU Male Test Condom 1 compared to NRL male control condom, The total clinical slippage rate of the PU male test condom (Test condom 1) compared to the NRL male control condom when used during vaginal intercourse.

The total clinical slippage rate is determined from the number of condoms that slipped completely off the penis during intercourse or withdrawal from the vagina, divided by the number of condoms used during vaginal intercourse, reported as a percentage., within 8 hours following each coital act for each condom use|Clinical breakage rate of PU Male Test Condom 2 compared to NRL male control condom, The total clinical breakage rate of the PU male test condom (Test condom 2) compared to the NRL male control condom when used during vaginal intercourse.

The total clinical breakage rate is determined from the number of condoms broken or torn during vaginal intercourse or withdrawal from the vagina divided by the number of condoms used during intercourse, reported as a percentage., within 8 hours following each coital act for each condom use|Clinical slippage rate of PU Male Test Condom 2 compared to NRL male control condom, The total clinical slippage rate of the PU male test condom (Test condom 2) compared to the NRL male control condom when used during vaginal intercourse.

The total clinical slippage rate is determined from the number of condoms that slipped completely off the penis during intercourse or withdrawal from the vagina, divided by the number of condoms used during vaginal intercourse, reported as a percentage., within 8 hours following each coital act for each condom use|Non-clinical breakage rate for each of the PU male condoms (test condom 1 and test condom 2) and the NRL male control condom., The total non-clinical breakage rate for each of the PU male test condom and the NRL male control condom when used during vaginal intercourse.

The total non-clinical breakage rate is determined from the number of condoms that tear during handling., within 8 hours following each coital act for each condom use|Non-clinical slippage respectively of each PU male test condom (test condom 1 and test condom 2) and the NRL male control condom., The total non-clinical slippage rate for each of the PU male test condoms and the NRL male control condom when used during vaginal intercourse.

The total non-clinical slippage rate is determined from the number of observations where the user fails to hold onto the condom at the base of the penis during withdrawal and/ or because the user delayed withdrawal after sex., within 8 hours following each coital act for each condom use|User acceptability of the 2 PU male test condoms (test condom 1 and test condom 2) and the NRL male control condom., User acceptability, experience, and preference for each condom type will be evaluated through participant-perceived questions.

Participant's experience on the use of each type of condoms \[Acceptability as assessed by participant perceived questionnaires (designed by following ISO 29943-1), within 8 hours following each coital act for each condom use|In-use tolerability of the 2 PU male test condoms (test condom 1 and test condom 2) and the NRL male control condom., The in-use tolerability of each condom type will be evaluated through participant-perceived questions (designed by following ISO 29943-1)., 5 weeks for each condom type