Reckitt Benckiser Healthcare (UK) Limited
This investigation is designed to evaluate the performance rate of two polyurethane male condoms with different sizes and thicknesses versus a standard natural rubber latex (NRL) male condom. The purpose of this study is to see how well the experimental condoms perform compared to the latex rubber condom (for example, how often the different condom types break or slip off the penis). Sponsor also wants to find out how well couples like using the three condom types and whether they experience any problems when using the condoms (for example, irritation or discomfort).
In this clinical investigation, new two PU male condoms (test condoms) will be evaluated against a marketed NRL male condom (control condom). This clinical investigation will also evaluate the in-use tolerance of the test and control condoms.
Inclusion Criteria: 1. Both partners participating must provide written informed consent. 2. Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive. 3. Both partners must be willing to respond to questions about their reproductive and contraceptive history and use of condoms during interviews and respond to self-administered questionnaires as per instructions. 4. Both partners must agree to answer the questions in the condom use questionnaires and two scales as soon as possible and within 2 (+6) hours following each coital act. 5. Bot…
A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.
A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.
A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a maximum 5-week period (assessment period). Couples will repeat the assessment period for each of the 3 condom types.