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 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT01859195
Eligibility Criteria:
Inclusion Criteria:
Women who:
* are between the ages of 18 and 45 at prescreening
* report vaginal sex with a man in the past 12 months at prescreening
* report negative pregnancy status and no intention to become pregnant during the course of the study
* report negative or unknown HIV status, and
* are willing and able to provide informed consent.
Exclusion Criteria:
Women who:
* self-report being pregnant, or intention to become pregnant during the course of the study
* self-report being HIV-positive
* self-report an allergy or sensitivity to vaginal contraceptive film (VCF), nonoxynol-9 (N9), or product(s) containing N9
* are unable or unwilling to give informed consent, or
* have any condition that, in the opinion of the project leader or principle investigator, would compromise the participant's ability to participate in the study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT01859195
Study Brief:
Protocol Section:
NCT01859195