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

RECRUITINGNA

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.

NCT06557499•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).

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.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Both partners participating must provide written informed consent.
•2. Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
•3. 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.
•4. 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.
•5. Both partners must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
•6. All couples must be averaging one act of intercourse weekly, agree to have penile-vaginal intercourse with a frequency sufficient to meet CIP requirements (a minimum of 5 coital acts over 5 weeks per assessment period-).
•7. The female partner must also use an established (as agreed by the Investigator) other highly effective form of non-barrier contraception, unless post-menopausal (confirmed menopausal prior to screening, amenorrhea for at least 12 months after cessation of exogenous hormone treatment) in which case no second form of contraception is required. Highly effective non-barrier contraception includes oral contraceptive (oestrogen and progestogen or progestogen-only hormonal contraception associated with inhibition of ovulation), intra-uterine device (IUD) or intra-uterine system (IUS), hormonal implant, injectables, patch and or sterilization of at least one partner (i.e., bilateral tubal ligation, vasectomy deemed medically successful).
•8. Both partners must be able to understand instructions for correct use of condoms.
•9. Both partners must have an adequate level of literacy to understand and to be able to answer the questionnaires.
•10. Both partners must agree to use only the investigational condoms during the time of participation.
+8 more criteria

Exclusion Criteria

•1. 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.
•2. 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.
•3. 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).
•4. Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
•5. Either partner needs to use condoms for sexually transmitted infection (STI) protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or herpes).
•6. Either partner has previous or planned genital surgery that in the opinion of the Investigator would consider the participant unsuitable to participate in the clinical investigation (e.g., laser for abnormal smear).
•7. Either partner are commercial sex workers.
•8. Either partner are itinerant persons who will be unable to complete the clinical investigation (e.g., migrant farm workers).
•9. Couples that in the opinion of the Investigator, would be unable to complete the investigation.
•10. Male partners that have known erectile or ejaculatory dysfunction in the past month.
+10 more criteria

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

Key Dates

Start Date

August 23, 2024

Primary Completion Date

May 19, 2025

Completion Date

May 19, 2025

Last Updated

February 18, 2025

Enrollment

600

ESTIMATED participants

Conditions

Contraception

Interventions

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

Contacts

Terri Walsh

CONTACT

+1 213 386 5614 twalsh@essentialaccess.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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