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:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT02934620
Eligibility Criteria:
Inclusion Criteria (for women):
* Not currently using a modern contraceptive method other than condoms or intending to start using a modern contraceptive method other than condoms in the next 6 months;
* Willing to use assigned study condoms as the sole method of contraception for the next six months;
* Not breastfeeding;
* Not known to be pregnant;
* Want to avoid pregnancy for at least the next six months; and
* Be in a monogamous relationship for at least the past six months with her current male partner.
Exclusion Criteria (for couples):
Couples are ineligible for study participation if either person in the couple is known to be HIV-positive or has any of the following contraindications to CSD500 use:
* History of low blood pressure or heart condition;
* Current use of medication for anemia, blood pressure, erectile dysfunction, migraines, headaches or glaucoma;
* Inflamed or broken skin that the condom could come into contact with; or
* Latex allergy or sensitivity.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02934620
Study Brief:
Protocol Section:
NCT02934620