Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male Condoms

Stopped early · Not applicable

Conditions studied: Performance of Synthetic Polyurethane Male Condom

In brief

This study is a randomized, double-blinded, crossover and multi-center study to evaluate the clinical breakage and slippage of a new synthetic polyurethane male condom compared to a commercially available standard latex condom.

Key facts

Study ID

NCT05536336

Run by

Okamoto Industries, Inc.

People needed

188

Starts

2022-09-08

Expected to finish

2024-06-27

Last updated by the study team

2025-03-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects are required to meet ALL of the following criteria for randomization into the study:
• mutually monogamous, current relationship ≥ 3 months;
• 18 years to 65 years of age;
• sexually active, sufficient to meet protocol requirements; agree to have penile-vaginal intercourse with frequency sufficient to meet protocol requirements;
• agree to use only study condoms during time of participation;
• agree not to use drugs, ointments or non-study devices that can affect sexual performance or might affect the condom's physical property;
• able to understand instructions for correct use of condoms;
• no known sexually transmitted infections including HIV/AIDS;
• agree to use only lubricant(s) provided by the study;
• agree to return any unopened condoms and lubricants;
• agree not to wear any genital piercing jewelry while using study condoms;
• l) willing to use the study products for minimum of 10 acts of vaginal intercourse within 6 weeks of study entry; l) willing and capable of following requirements of protocol, including willingness to respond to questions about reproductive and contraceptive history and use of condoms during interviews; m) agree to use and has internet/web access in order to complete the Diaries and Surveys using iMedNet's ePRO module; n) available for follow-up and reachable by telephone.

You may not qualify if…

• Subjects will be excluded in ANY of the following exclusion criteria apply at the time of entry or at the time during the study. If either partner is (or becomes) aware that:
• he/she is allergic or sensitive to natural rubber latex or polyurethane,
• female partner is pregnant or desires to become so while participating in study,
• subject knowingly has a sexually transmitted infection,
• commercial sex workers,
• itinerant persons who cannot be able to complete the study, e.g. migrant farm workers,
• male partner has known erectile or ejaculatory dysfunction,
• either partner is using any medications or preparation applied topically or intravaginally to the genitalia other than that supplied for the study,
• either partner is an employee of study sponsor, competitor or affiliated with clinical research center,
• currently participating in another sexual health clinical study.

Where it is running

• Physicians Research Group — Mesa, Arizona, United States
• Angels Clinical Research Center — Miami, Florida, United States
• Physicians Research Group — West Lafayette, Indiana, United States
• Wellnow — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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