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Barrier Method
Evaluation of Polyurethane Male Condoms
N/A
Waitlist Available
Research Sponsored by Sagami Rubber Industries Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up self completion of questionnaires within 12 hours of use.
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing two new types of thin, lubricated plastic condoms against a commonly used condom. It involves 300 heterosexual couples to see if the new condoms are as effective and acceptable as the commonly used ones. The study will check how often the condoms break or slip off and gather feedback from the couples.
Eligible Conditions
- Safe sex
- Birth Control
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ self completion of questionnaires within 12 hours of condom use. questionnaires returned to investigators when receiving next set of 5 condoms. all sets of questionnaires returned within 9 weeks of couple starting.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~self completion of questionnaires within 12 hours of condom use. questionnaires returned to investigators when receiving next set of 5 condoms. all sets of questionnaires returned within 9 weeks of couple starting.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Non Inferiority Analysis of Each of the Experimental Condoms Verses the Control Condom With Respect to Clinical Failure Rates (Combined Breakage and Slippage) as Per ISO 29943-1:2017.
Secondary study objectives
Acceptability Measures
Awards & 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 Condom BExperimental Treatment1 Intervention
Polyurethane Condom B (001)
Group II: Polyurethane Condom AExperimental Treatment1 Intervention
Polyurethane Condom A (002)
Group III: Control Latex Condom CActive Control1 Intervention
Commercial Natural Rubber Latex Male Condom
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Control Latex Condom C, Polyurethane Condom A, Polyurethane Condom B
2020
N/A
~600
Find a Location
Who is running the clinical trial?
Sagami Rubber Industries Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
Essential Access HealthOTHER
6 Previous Clinical Trials
2,870 Total Patients Enrolled
Grant R BurtStudy ChairSagami Rubber Industries Co., Ltd.
1 Previous Clinical Trials
300 Total Patients Enrolled
William D Potter, PhDStudy DirectorStapleford Scientific Services Limited
1 Previous Clinical Trials
300 Total Patients Enrolled