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Barrier Method

Polyurethane Condom A for Birth Control

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

Study Summary

This trial will compare the clinical failure rates of two different thicknesses of lubricated polyurethane male condoms to a marketed lubricated control male condom made of natural rubber latex. The study will also compare the acceptability of the two polyurethane condom different thicknesses with that of the natural rubber latex control condom.

Eligible Conditions
  • Birth Control
  • STI Prevention

Timeline

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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Acceptability Measures

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
2,570 Total Patients Enrolled
Grant R BurtStudy ChairSagami Rubber Industries Co., Ltd.
1 Previous Clinical Trials
300 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Essential Access Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of Polyurethane Male Condoms
2020. "Evaluation of Polyurethane Male Condoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04622306.
~67 spots leftby Apr 2025
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