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

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.

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

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