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NCT06557499 · ClinicalTrials.gov registry record · 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.
A NA study of Contraception, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
- Recruiting
- Registry status
- NA
- Development phase
- 600
- Enrollment target
- 3
- Study locations
NCT06557499: Recruiting NA study of Contraception, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
NCT06557499 is a NA study of Contraception that is actively recruiting participants, run by Reckitt Benckiser Healthcare (UK) Limited. The registered enrollment target is 600 participants, above the 446-participant average among 72 other Contraception trials with a reported enrollment target (35% higher). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06557499, a NA study of Contraception, is actively recruiting participants, sponsored by Reckitt Benckiser Healthcare (UK) Limited.
- RECRUITING
- Registry status
- NA
- Development phase
- 600 participants
- Enrollment target
- 3
- Study locations
Study 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
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, reported by participants.
Conditions Studied
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
Study Locations (3)
California
- Essential Access Health-Berkeley - Berkeley
- Essential Access Health -Los Angeles - Los Angeles
Washington
- Essential Acess Health- Seattle - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-08-23 |
| Est. Completion | 2025-05-19 |
| Phase | NA |
What NCT06557499 shows while recruiting
NCT06557499 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 446-participant average among 72 other Contraception trials with a reported enrollment target (35% higher).
The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 3 interventions - of which Polyurethane (PU) male condom-Test condom 1 is the first listed.
NCT06557499 reports a single indexed study location in California, Washington.
Frequently Asked Questions
What is clinical trial NCT06557499 about?
NCT06557499 is a clinical study titled "A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.". 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 ...
What is the current status of trial NCT06557499?
This trial is currently recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2024-08-23. Estimated completion is 2025-05-19.
What conditions does trial NCT06557499 study?
This clinical trial studies the following conditions: Contraception.
What interventions are being tested in trial NCT06557499?
The interventions under investigation include: Polyurethane (PU) male condom-Test condom 1 (DEVICE), Polyurethane (PU) male condom-Test condom 2 (DEVICE), Natural Rubber Latex (NRL) male condom- Control condom (DEVICE).
Who is sponsoring clinical trial NCT06557499?
This trial is sponsored by Reckitt Benckiser Healthcare (UK) Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06557499 being conducted?
This trial has 3 study locations across California, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Contraception
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06557499's enrollment target sits among peer trials
600 20th of 72 higher than 53 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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