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 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT00213018
Eligibility Criteria:
Inclusion Criteria:
* In good health as determined by medical history, physical examination and results of laboratory screening tests for RTIs
* Aged 18 years or older
* Resident in the area for at least one year and planning to stay for at least 12 months
* HIV-seronegative at screening
* Willing and able to comply with the study protocol (including being tested for HIV, learning the results, and undergoing clinical evaluations), and,
* Able to give informed consent
Exclusion Criteria:
* Pregnant or desire to become pregnant during the trial
* Delivered or aborted a pregnancy within the six weeks prior to screening
* History of surgery on external genitalia, vagina or cervix in the six weeks prior to screening
* Recent history of non-menstrual vaginal bleeding with intercourse
* Clinically detectable genital abnormality (including presence of warts, or a structural or congenital abnormality)
* Clinical suspicion of a RTI (defined as the presence of a genital ulcer visible to the naked eye, an abnormal vaginal discharge or purulent cervicitis, or untreated positive STI test result)
* Abnormal Pap smear
* History of sensitivity/allergy to latex
* Participating in another trial of a vaginal product
* Reported injection of recreational drugs
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00213018
Study Brief:
Protocol Section:
NCT00213018