A Randomized, Double-Blinded, Crossover and Multi-center Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male Condom Compared to Standard Latex Condom During Vaginal Intercourse
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Performance of Synthetic Polyurethane Male Condom
- Sponsor
- Okamoto Industries, Inc.
- Enrollment
- 235
- Locations
- 3
- Primary Endpoint
- The total clinical failure rates for the test and control condoms
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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. The duration of participation for each couple is approximately 6 weeks. Study subjects are given a set of one condom type to use for up to three consecutive weeks to complete each evaluation and then return for a set of the other condom type for another period of up to three weeks of evaluation. The primary objective of this study is to determine whether the total clinical failure rate of a new test condom is comparable with the total clinical failure rate of a legally marketed latex condom when used during vaginal intercourse. The secondary objective of this study is to evaluate the clinical slippage and breakage of the polyurethane and latex condoms, as well as user acceptance about using the devices and adverse events.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
The total clinical failure rates for the test and control condoms
Time Frame: 6 weeks
The total clinical failure rate of a new test condom is comparable with the failure rate of a commercially available latex condom when used during vaginal intercourse as reported by study participant questionnaire.
Secondary Outcomes
- Clinical / Non-clinical slippage rates acceptability; and Adverse events(6 weeks)
- Clinical/non-clinical breakage rates(6 weeks)
- User acceptance(6 weeks)
- Adverse events(6 weeks)