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 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT01452503
Eligibility Criteria:
Inclusion Criteria:
* All women enrolled in this research must meet the following selection criteria:
1. must be at least 18 years of age.
2. must be literate (able to read a newspaper or letter easily).
3. must be sexually active (defined as having at least two vaginal coital acts per week and not being abstinent in the month prior to enrollment).
4. must be in an exclusive (monogamous) sexual relationship with her spouse or partner while participating in this research study.
5. must have been in a sexual relationship with this partner for at least 6 months.
6. must be without evidence of STI as determined through syndromic diagnosis and vaginal examination.
7. must be on hormonal or other non-barrier contraception (e.g. OCs, injectables, IUD, or have had a tubal sterilization or be post-menopausal-defined as 12 months with no period).
8. must be willing to give informed consent.
9. must be able to complete condom use log.
10. must be willing to use the study condoms as directed.
11. must be willing to adhere to the follow-up schedule and all study procedures.
12. must have successfully completed a given phase of study before advancing into subsequent phases (e.g. successfully completing Part 1 before advancing to Part 2, etc.).
13. must be willing to provide research study staff with an address, phone number or other locator information while participating in the study.
14. must be willing to participate in the study for up to six months.
* Exclusion Criteria:
1. must not be a sex worker.
2. must not be pregnant (as determined by pregnancy testing) or planning a pregnancy during the time of the research study.
3. must not be breastfeeding.
4. must not have known sensitivities or allergies to latex, polyurethane, vaginal/sexual lubricants or the lubricants used on condoms.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01452503
Study Brief:
Protocol Section:
NCT01452503