Recruiting

Polyurethane Male Condoms with Different Size and Thickness in Healthy Couples

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Polyurethane (PU) male condom-Test condom 1

+ Polyurethane (PU) male condom-Test condom 2

+ Natural Rubber Latex (NRL) male condom- Control condom

Device
Who is being recruted

From 18 to 60 Years
+38 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorReckitt Benckiser Healthcare (UK) Limited
Study ContactTerri Walsh
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 23, 2024

Actual date on which the first participant was enrolled.

This study is designed to compare the performance of two new types of polyurethane (PU) male condoms with different sizes and thickness against a widely-used thin latex male condom. The focus is on healthy couples who are in a monogamous relationship and engage in vaginal intercourse. The goal is to understand how these new PU condoms perform in real-life situations and to see if they are a good alternative to latex condoms. This is important because it could provide more options for people who are allergic to latex or prefer different condom materials. Participants in this study will use each type of condom during vaginal intercourse and provide feedback on their experiences. The study will evaluate how well each condom performs and how comfortable they are to use. There are no specific risks mentioned, but the benefits could include finding a new condom material that offers the same or better protection and comfort as current options. Participants' experiences will help researchers determine the in-use tolerance and overall effectiveness of these new PU condoms.

Official TitleA 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.
NCT06557499
Principal SponsorReckitt Benckiser Healthcare (UK) Limited
Study ContactTerri Walsh
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

18 inclusion criteria required to participate
Both partners participating must provide written informed consent.
Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
Both partners must be willing to respond to questions about their reproductive and contraceptive history and use of condoms during interviews and respond to self-administered questionnaires as per instructions.
Both partners must agree to answer the questions in the condom use questionnaires and two scales as soon as possible and within 2 (+6) hours following each coital act.
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20 exclusion criteria prevent from participating
Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or any lubrication products provided.
Either partner has been receiving daily treatment for their pre-existing skin condition (for example, severe eczema/psoriasis) within the three months prior to the screening for this study.
Female partner that is pregnant or desires to become so while participating in investigation, (females of childbearing potential must have a negative pregnancy test as part of screening).
Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Recruiting

Essential Access Health-Berkeley

Berkeley, United StatesOpen Essential Access Health-Berkeley in Google Maps
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Essential Access Health -Los Angeles

Los Angeles, United States
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Essential Acess Health- Seattle

Seattle, United States
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3 Study Centers
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