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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01268332
Eligibility Criteria:
Inclusion Criteria:
* HIV uninfected
* General good health
* Sexually active
* Agree to use an effective method of contraception
* Normal Pap smear result within 12 months prior to study entry
* Agree to not participate in other drug or device research studies for the duration of study participation
* Agree to not use any intravaginal product for the duration of study participation
Exclusion Criteria:
* History of adverse reaction to silicone, latex, or titanium dioxide
* Current male sex partner with known history of adverse reaction to silicone, latex, or titanium dioxide
* Last pregnancy outcome within 30 days or less prior to enrollment
* History of hysterectomy
* Any abnormal pelvic exam finding
* Pregnant
* Condition that, in the opinion of the investigator, would interfere with the study
* Severe pelvic relaxation
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01268332
Study Brief:
Protocol Section:
NCT01268332