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 range
18 Years – 45 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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
. 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