Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT05308992
Eligibility Criteria:
Inclusion Criteria:
1. Between the ages of 18 and 45 years (inclusive)
2. Willing and able to give signed informed consent.
3. Willing to respond to questions concerning their reproductive and contraceptive history and use of condoms contained on self-administered questionnaires, online questionnaires or in-person interviews.
4. Have vaginal intercourse at least once weekly.
5. Protected against pregnancy by oral contraceptives, an intrauterine device, an implant, contraceptive injections, contraceptive patch, or sterilization (tubal ligation or vasectomy).
6. Willing to use the study products for four acts of vaginal intercourse within three weeks of study entry.
7. In a mutually monogamous relationship with their study partner for at least 6 months and be willing to remain mutually monogamous throughout study participation.
i. Agree not to wear any genital piercing jewelry or use sex toys while using the study condoms.
j. Agree not to use drugs that could enhance or diminish sexual response, including testosterone, poppers, and drugs like Viagra and Cialis when using study condoms.
k. Agree not to use alcohol in amounts that could enhance or diminish sexual response when using the condoms.
l. Agree to return any unopened condoms m. Have home access to the internet, a valid personal email for each partner and be reachable by mobile phone.
n. Willing to participate in either in-person visits or remote study visits conducted via videoconference and telephone and curbside exchange.
o. Agree to complete online questionnaires after testing each study product and group of study products.
p. Male partner agrees to ejaculate during vaginal intercourse. q. Willing to complete interviews by phone or video with HydroGlyde Coatings representatives.
r. Each partner has used 10 or more male condoms in their lifetime. s. Willing to sign a confidentiality agreement pertaining to the study condoms.
Exclusion Criteria:
1. Currently participating in another clinical study.
2. Female partner self-reported as pregnant.
3. Allergic to natural rubber latex or has a history of recurrent adverse events following use of latex products.
4. Known allergy or skin sensitivity to common cosmetics and/or contact lens solutions or polyvinylpyrrolidone (PVP).
5. Unable to follow instructions or strictly adhere to the study schedule.
6. At significant (high) risk of sexually transmitted infections, including human immunodeficiency virus infection, or having a medical history of recurrent, serious sexually transmitted infection (e.g. gonorrhea, syphilis, chlamydia).
7. Currently using condoms for protection against a known sexually transmitted infection.
8. Taking any internally applied medication or oral medication to treat a genital condition.
9. Male partner has had difficulty achieving or maintaining an erection, or achieving ejaculation in the last month under typical circumstances/conditions.
10. Any self-reported genital condition (e.g. itching, burning, irritation, etc.) which, in the opinion of the investigator, could affect use of the study condoms or the ability to interpret study data.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05308992
Study Brief:
Protocol Section:
NCT05308992