Evaluation of Polyurethane Male Condoms (NCT04622306) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Polyurethane Male Condoms
United States300 participantsStarted 2020-10-12
Plain-language summary
The clinical study will compare two lubricated polyurethane male condoms of different thickness with a marketed lubricated control male condom made of natural rubber latex. This crossover study will randomize 300 heterosexual couples to the sequence in which they use five condoms of each of the three study condom types. The clinical failure (breakage and slippage) rates of the two polyurethane condoms will be compared to the clinical failure (breakage and slippage) rate of commercial natural rubber latex control condom using a statistical test of non-inferiority. The study will also compare the acceptability of the two polyurethane condom different thickness with that of the natural rubber latex control condom obtained from interviews and questionnaires with subject couples.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion criteria
✓. Between the ages of 18 and 45 (inclusive)
✓. Protected against pregnancy by oral contraceptives, an IUD, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy)
✓. Have home internet access, a valid personal email for each partner, ability to videoconference and use electronic signature technology
✓. Willing and able to give electronic informed consent
✓. Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms via interview or self-administered questionnaires
✓. Have vaginal intercourse at least once weekly
✓. Willing to use the study products for fifteen acts of vaginal intercourse within nine weeks of study entry
✓. In a mutually exclusive monogamous relationship with their study partner for at least 6 months and be willing to remain mutually monogamous throughout study participation
Exclusion criteria
What they're measuring
1
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.
Timeframe: 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.
. Currently participating in another similar clinical study
✕. Female partner self-reported as pregnant
✕. Allergic to natural rubber latex or polyurethane, or has a history of recurrent adverse events following use of latex or polyurethane products
✕. Unable to follow study requirements, use instructions or attend study visits or exchanges
✕. Have a significant (high) risk of STIs, including HIV infection, or having a medical history of recurrent, uncontrolled STIs (e.g. gonorrhoea, syphilis, Chlamydia, etc.)
✕. Currently using condoms for protection against a known STI
✕. Taking any internally applied medication to treat a genital condition that could interact with the study condom
✕. Male partner has used medication that has caused erectile dysfunction, or had difficulty achieving/maintaining an erection, or achieving ejaculation in the last month under typical circumstances/conditions