A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyure… (NCT06557499) | Clinical Trial Compass
CompletedNot Applicable
A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.
United States598 participantsStarted 2024-08-23
Plain-language summary
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).
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Both partners participating must provide written informed consent.
. Couples must include a male and female within a heterosexual couple and be between 18 - 60 years of age inclusive.
. 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.
. 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.
. Both partners must be generally healthy and in a mutually monogamous heterosexual relationship - current relationship ≥ 3 months.
. All couples must be averaging one act of intercourse weekly, agree to have penile-vaginal intercourse with a frequency sufficient to meet CIP requirements (a minimum of 5 coital acts over 5 weeks per assessment period-).
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
Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 1: PU 57 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom.
Timeframe: within 8 hours following each coital act for each condom use
2
Total Clinical Failure Rate of Polyurethane (PU) Male (Test Condom 2: PU 63 mm) Condom Compared to Control Condom: Natural Rubber Latex (NRL) 57 mm Male Condom.
Timeframe: within 8 hours following each coital act for each condom use
. The female partner must also use an established (as agreed by the Investigator) other highly effective form of non-barrier contraception, unless post-menopausal (confirmed menopausal prior to screening, amenorrhea for at least 12 months after cessation of exogenous hormone treatment) in which case no second form of contraception is required. Highly effective non-barrier contraception includes oral contraceptive (oestrogen and progestogen or progestogen-only hormonal contraception associated with inhibition of ovulation), intra-uterine device (IUD) or intra-uterine system (IUS), hormonal implant, injectables, patch and or sterilization of at least one partner (i.e., bilateral tubal ligation, vasectomy deemed medically successful).
. Both partners must be able to understand instructions for correct use of condoms.
Exclusion criteria
. Either partner is or becomes aware of an allergy or sensitivity to the ingredients of any of the products, including the test or control condoms or any lubrication products provided.
. Either partner has been receiving daily treatment for their pre-existing skin condition (for example, severe eczema/psoriasis) within the three months prior to the screening for this study.
. Female partner that is pregnant or desires to become so while participating in investigation, (females of childbearing potential must have a negative pregnancy test as part of screening).
. Any couple undergoing any form of fertility treatment such as in-vitro fertilisation.
. Either partner needs to use condoms for sexually transmitted infection (STI) protection (e.g., discordance for Human Immunodeficiency Virus (HIV) or herpes).
. Either partner has previous or planned genital surgery that in the opinion of the Investigator would consider the participant unsuitable to participate in the clinical investigation (e.g., laser for abnormal smear).
. Either partner are commercial sex workers.
. Either partner are itinerant persons who will be unable to complete the clinical investigation (e.g., migrant farm workers).