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Barrier Method
Polyurethane vs Latex Condoms for Birth Control
N/A
Recruiting
Led By Terri Walsh
Research Sponsored by Reckitt Benckiser Healthcare (UK) Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Both partners must have no known sexually transmitted infections including Human Immunodeficiency Virus (HIV) / acquired immune deficiency syndrome (AIDS)
Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive
Must not have
Female partner that is pregnant or desires to become so while participating in investigation
Either partner requires to use/ is using medication or preparations that are applied topically to the genitalia area or intravaginally, other than that supplied for the investigation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 8 hours following each coital act for each condom use
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare the effectiveness and user experience of two different polyurethane male condoms with varying sizes and thicknesses against a standard natural rubber latex male condom. Researchers want to see how often the
Who is the study for?
This trial is for healthy monogamous couples who are interested in testing the performance of two different sized polyurethane condoms compared to a standard latex condom. Couples must be willing to use all three types and report on their experiences.
What is being tested?
The study aims to compare the effectiveness and user satisfaction between two sizes of polyurethane condoms and one standard natural rubber latex condom, by assessing rates of breakage, slippage, and any discomfort or problems during use.
What are the potential side effects?
Potential side effects may include irritation or discomfort from using the different types of condoms. However, these are typically mild and vary based on individual sensitivity to condom materials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My partner and I are both free from sexually transmitted infections, including HIV/AIDS.
Select...
I am in a heterosexual relationship, and both of us are between 18 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My female partner is pregnant or wants to become pregnant during the study.
Select...
My partner or I use genital or intravaginal medications not provided by this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 8 hours following each coital act for each condom use
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 8 hours following each coital act for each condom use
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total clinical failure rate of Polyurethane (PU) male (Test condom 1) condom compared to Natural Rubber Latex (NRL) male condom.
Total clinical failure rate of Polyurethane (PU) male (Test condom 2) condom compared to Natural Rubber Latex (NRL) male condom.
Secondary study objectives
Clinical breakage rate of PU Male Test Condom 1 compared to NRL male control condom
Clinical breakage rate of PU Male Test Condom 2 compared to NRL male control condom
Clinical slippage rate of PU Male Test Condom 1 compared to NRL male control condom
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Polyurethane (PU) male condom-Test condom 2Experimental Treatment1 Intervention
Group II: Polyurethane (PU) male condom-Test condom 1Experimental Treatment1 Intervention
Group III: Natural Rubber Latex (NRL) male condom- Control condomActive Control1 Intervention
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Who is running the clinical trial?
Reckitt Benckiser Healthcare (UK) LimitedLead Sponsor
31 Previous Clinical Trials
4,809 Total Patients Enrolled
Novotech (Australia) Pty LimitedIndustry Sponsor
74 Previous Clinical Trials
7,451 Total Patients Enrolled
Terri WalshPrincipal InvestigatorEssential Access Health