Actively Recruiting
A Randomized, Single-Masked, 3-Way Crossover Study to Evaluate Two Polyurethane Male Condoms Versus a Thin Latex Male Condom in Healthy Monogamous Couples
Led by Reckitt Benckiser Healthcare (UK) Limited · Updated on 2025-02-18
600
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating the performance of two new polyurethane male condoms of different sizes and thicknesses compared to a standard natural rubber latex male condom. The study aims to find out how often each condom type breaks or slips off during vaginal intercourse and to assess how well couples tolerate and accept these condoms. This investigation is sponsored by Reckitt Benckiser Healthcare (UK) Limited and involves healthy monogamous heterosexual couples. Couples will use each of the three condom types during separate assessment periods lasting up to 5 weeks each. During these periods, they will receive a minimum of 5 and a maximum of 7 condoms per type to use during vaginal intercourse. The study uses a randomized, single-masked, three-way crossover design, allowing couples to try each condom type and compare their experience. Participants will be asked to complete questionnaires and scales shortly after each sexual act, reporting any issues such as irritation or discomfort. Data on condom breakage, slippage, and overall acceptability will be collected within 8 hours after intercourse. Partners will also measure erect penis size at the start using a provided kit. Follow-up and adherence are monitored through an electronic web-based platform, with couples expected to have at least one intercourse act per week during each 5-week assessment period.
CONDITIONS
Brief 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 and aged 18 to 60 years inclusive
- 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 after intercourse
- Both partners must be generally healthy and in a mutually monogamous heterosexual relationship of at least 3 months
- Couples must have an average of one intercourse act per week and agree to at least 5 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 instructions for correct condom use
- Both partners must have adequate literacy to answer questionnaires
- Both partners must agree to use only the investigational condoms during participation
- Participants must agree to use the penis measuring kit at study start
- Both partners must agree not to use drugs or devices affecting sexual performance
- Both partners must have no known sexually transmitted infections, except asymptomatic HSV or HPV if approved by Investigator
- Both partners must use only provided lubricants during study
- Both partners must agree not to wear genital piercing jewelry during study
- Both partners must have no clinically relevant health conditions
- Couples must have compatible internet device for uploading data
- Both partners must be available for follow-up
You will not qualify if you...
- Allergy or sensitivity to any study product or lubricant
- Recent daily treatment for severe skin conditions (e.g., eczema, psoriasis) within 3 months
- Female partner pregnant or planning pregnancy during study; negative pregnancy test required
- Couples undergoing fertility treatment
- Need for condoms for STI protection (e.g., HIV discordance)
- Previous or planned genital surgery affecting participation
- Commercial sex workers
- Itinerant persons unable to complete study
- Known erectile or ejaculatory dysfunction in male partner within past month
- Use of topical genital medications other than study products
- Female partner treated for vaginal complaints in past 3 months
- Use of medications interfering with condom use
- Male partner with abnormal penile anatomy or genital lesions affecting condom use
- Health conditions affecting safety or study outcomes
- Participation in another clinical trial within past month
- Employment or affiliation with sponsor or research center
- History of drug or alcohol abuse in past 12 months
- Inability to follow study procedures due to language or psychological issues
- Inability to fully comply with study requirements as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 weeks per condom type, repeated for 3 condom types
Participants use each of the three condom types during vaginal intercourse in a crossover design. Couples receive 5 to 7 condoms per type and use them over a maximum 5-week assessment period for each condom type.
3 assessment periods, each up to 5 weeks
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
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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