Loading clinical trials...

A Clinical Investigation to Assess the Performance of a Polyurethane Condom Versus a Latex Condom in Healthy Monogamous Couples | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Clinical Investigation to Assess the Performance of a Polyurethane Condom Versus a Latex Condom in Healthy Monogamous Couples

A Randomized, Assessor-masked, 2-way Cross-over, Multi-centre, Clinical Investigation to Evaluate the Performance Rate of a Polyurethane Condom in Healthy Monogamous Couples When Compared With a Standard Latex Condom

NCT04134039•Reckitt Benckiser Healthcare (UK) Limited

View on ClinicalTrials.gov

Summary

This investigation is designed to evaluate the performance rate of a polyurethane (PU) condom versus a standard natural rubber latex (NRL) condom.

Detailed Description

In this clinical investigation, a new PU male condom (test condom) will be evaluated against a marketed NRL male condom (reference condom). This clinical investigation will also evaluate the in-use tolerance of the test and reference condoms.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. A male and a female subject aged: 18 - 60 years inclusive.
•2. All subjects must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
•3. All couples must be sexually active and agree to have penile-vaginal intercourse with a frequency sufficient to meet protocol requirements (a minimum of 5 coital acts over 4 weeks).
•4. The female partner should already be on an established highly effective form of non-barrier contraception, unless post-menopausal.
•5. Couples must agree not to use drugs or non-investigational devices that can affect sexual performance.

Exclusion Criteria

•1. Either partner is or becomes aware of an allergy or sensitivity to the ingredients of the test products, including the test or reference condoms.
•2. Either partner has a pre-existing skin condition (severe eczema/ psoriasis) or systemic allergic reactions or as confirmed by the subject and physical examination.
•3. Either partner that needs to use condoms for a specific sexually transmitted infection (STI) protection e.g. discordance for Human Immunodeficiency Virus (HIV) or herpes.
•4. Subjects that have previous or planned genital surgery, that in the opinion of the Investigator would consider the subject unsuitable to participate in the clinical investigation e.g. laser for abnormal smear.
•5. Male partners that have known erectile or ejaculatory dysfunction.
•6. A female partner that has been diagnosed with or treated for vaginal complaints (including vaginal dryness) in the previous 3 months which, in the opinion of the investigator, deems the partner unsuitable for the investigation.
•7. Any subject who has clinical symptoms or signs of a sexually transmitted diseases (STD) or HIV/ AIDS or has a previous history of high-risk behaviour as judged by the investigator.
•8. Female partner using medication which in the investigator's opinion would affect vaginal mucosal secretion, such as Chlorpheniramine at any time in the 14 days (or 5 half-lives of the drug, whichever is longer) before first condom use.
•9. A male partner with abnormal penile anatomy that would, in the opinion of the investigator, affect the ability to keep the condom in place during intercourse.
•10. Either partner intends to continue to use antihistamines, anti-inflammatory drugs or pain killers for the duration of the investigation.

Locations (1)

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Key Dates

Start Date

February 9, 2021

Primary Completion Date

July 5, 2021

Completion Date

July 5, 2021

Last Updated

September 16, 2021

Enrollment

470

ACTUAL participants

Conditions

Control of PregnancyPrevention of Sexually Transmitted Infections

Interventions

Polyurethane (PU) condom

DEVICE

Natural Rubber Latex (NRL) condom

DEVICE

A Clinical Investigation to Assess the Performance of Natural Rubber Latex Condoms in Couples

NCT03739190

Control of PregnancyPrevention of Sexually Transmitted Infections

View study

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: September 16, 2021Data 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.

View ClinicalTrials.gov Terms and Conditions