Actively Recruiting
A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.
Led by Reckitt Benckiser Healthcare (UK) Limited · Updated on 2025-02-18
600
Participants Needed
3
Research Sites
38 weeks
Total Duration
On this page
Sponsors
R
Reckitt Benckiser Healthcare (UK) Limited
Lead Sponsor
N
Novotech (Australia) Pty Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both partners must provide written informed consent.
- Couples must be heterosexual with a male and female partner aged 18 to 60 years.
- Both partners must be willing to answer questions about reproductive and contraceptive history and condom use.
- Both partners must agree to complete condom use questionnaires and scales within 2 (+6) hours following intercourse.
- Both partners must be generally healthy and in a mutually monogamous relationship of at least 3 months.
- Couples must average at least one vaginal intercourse per week and have a minimum of 5 coital acts over 5 weeks per assessment period.
- Female partner must use a highly effective non-barrier contraception method unless post-menopausal.
- Both partners must understand correct condom use instructions.
- Both partners must have enough literacy to complete questionnaires.
- Both partners agree to use only study-provided condoms during participation.
- Participants must agree to use the penis measuring kit at study start.
- Both partners agree not to use drugs or devices affecting sexual performance.
- Both partners must have no known sexually transmitted infections including HIV/AIDS, except asymptomatic uncomplicated HSV or HPV with investigator approval.
- Both partners agree to use only provided lubricants during the study.
- Both partners agree not to wear genital piercing jewelry during the study.
- Both partners must have no past medical history considered clinically relevant by the investigator.
- Couples must have a compatible internet-connected device to upload questionnaire data.
- Both partners must be available for follow-up.
You will not qualify if you...
- Either partner is allergic or sensitive to any product ingredients including condoms or lubricants.
- Either partner has received daily treatment for skin conditions (e.g., severe eczema/psoriasis) within 3 months prior to screening.
- Female partner is pregnant or wishes to become pregnant during the study; females of childbearing potential must have a negative pregnancy test.
- Couples undergoing fertility treatments such as in-vitro fertilization.
- Either partner requires condoms for STI protection (e.g., discordance for HIV or herpes).
- Either partner has previous or planned genital surgery that could affect suitability.
- Either partner is a commercial sex worker.
- Either partner is an itinerant person unable to complete the study.
- Couples considered unlikely to complete the study by the investigator.
- Male partner has known erectile or ejaculatory dysfunction within the past month.
- Either partner uses topical or intravaginal medications not supplied by the study.
- Female partner has been diagnosed or treated for vaginal complaints in the previous 3 months deemed unsuitable by the investigator.
- Either partner uses medications that may interfere with condom use.
- Male partner has abnormal penile anatomy or genital lesions affecting condom use.
- Either partner has health conditions affecting study outcome or safety.
- Either partner participated in another clinical trial within the previous month that could affect this study.
- Either partner is an employee or family member of the sponsor or research center.
- Either partner has a recent history of drug or alcohol abuse within the past 12 months.
- Either partner is unable to follow study procedures due to language, psychological, or health issues.
- Either partner is unable to comply fully with study requirements as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Essential Access Health-Berkeley
Berkeley, California, United States, 90010
Actively Recruiting
2
Essential Access Health -Los Angeles
Los Angeles, California, United States, 90017
Actively Recruiting
3
Essential Acess Health- Seattle
Seattle, Washington, United States, 98005
Actively Recruiting
Research Team
T
Terri Walsh
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
3
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