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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT02134535
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-45
2. Free from abnormal vaginal discharge or other current vaginal symptoms
3. HIV uninfected. Note: if a woman recently participated in a recent research study and has an HIV test result available from that study, this will suffice provided the date of the test is within 6 months of the enrollment visit for this trial. Otherwise, the potential participant should under go testing at the first study visit.
4. Willing and able to give informed consent to take place in the study
5. Willing to undergo a pelvic examination and genital biopsies
6. Willing to provide contact information
7. Agree to be sexually abstinent for two weeks beginning one week prior to the enrollment visit
Exclusion Criteria:
1. Menopausal
2. Pregnant or within 90 days of last pregnancy
3. Hysterectomy
4. Use of a diaphragm, NuvaRing or spermicide for contraception
5. Reports a course of antibiotic therapy in the 14 days prior to enrollment
6. Known history of platelet disorder or coagulapathy.
7. Participation in another microbicide or contraceptive study or a study involving cervical and/or vaginal biopsies within one month of enrollment
8. Use of any spermicide or spermicide-lubricated condom within one week of enrollment.
9. Use of any internal vaginal device or product with the exception of tampons within one week of enrollment
10. Any other condition that in the opinion of the site investigator would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02134535
Study Brief:
Protocol Section:
NCT02134535