Performance of Synthetic Polyurethane Male Condom
Conditions
Keywords
condom
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.
Interventions
DEVICECondom
Contraception
Sponsors
NAMSA
Okamoto Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects are required to meet ALL of the following criteria for randomization into the study: 1. mutually monogamous, current relationship ≥ 3 months; 2. 18 years to 65 years of age; 3. sexually active, sufficient to meet protocol requirements; agree to have penile-vaginal intercourse with frequency sufficient to meet protocol requirements; 4. agree to use only study condoms during time of participation; 5. agree not to use drugs, ointments or non-study devices that can affect sexual performance or might affect the condom's physical property; 6. able to understand instructions for correct use of condoms; 7. no known sexually transmitted infections including HIV/AIDS; 8. agree to use only lubricant(s) provided by the study; 9. agree to return any unopened condoms and lubricants; 10. 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.
Exclusion criteria
Subjects will be excluded in ANY of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total clinical failure rates for the test and control condoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical / Non-clinical slippage rates acceptability; and Adverse events | 6 weeks | Evaluate the slippage rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire. |
| Clinical/non-clinical breakage rates | 6 weeks | Evaluate the breakage rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire. |
| User acceptance | 6 weeks | Evaluate the user acceptance rates of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaire. |
| Adverse events | 6 weeks | Evaluate the number of adverse events of the polyurethane and the commercially available latex condom when used during vaginal intercourse, as reported by the study participant questionnaires and study Primary Investigators. |
Countries
United States
Outcome results
None listed