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 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT01334827
Eligibility Criteria:
Inclusion Criteria:
Women who:
* are between the ages of 18 and 45
* report vaginal sex with their male sexual partner in the past 6 months
* report being in a monogamous sexual relationship with their male partner
* report consistent use of an effective birth control method: e.g., hormonal contraceptive, IUD, bilateral tubal ligation, Essure® or any non-incisional permanent birth control procedure, hysterectomy (partial or total, with/without oophorectomy), partner's vasectomy/salpingectomy
* are able to tolerate film use, as measured by pelvic exam at Visit 1B
* are willing to refrain from any vaginal product use (inclusive of douching) for 48 hours before Visit 1B and until they complete all study activities (except for study-related products)
* are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4
* are willing to use condoms for vaginal-penile sex between all study visits (Visits 1A - 4)
* are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4)
* are willing to undergo HIV testing and receive test results and counseling.
Men who:
* are at least 18 years of age
* report vaginal sex with their female sexual partner in the past 6 months
* report being in a monogamous sexual relationship with their female sexual partner
* are willing to refrain from having vaginal intercourse 24 hours before Visit 1B and Visits 2-4
* are willing to use condoms for vaginal-penile sex between all of study visits (Visits 1A-4)
* are willing to refrain from any non-penile vaginal penetration during dosage form evaluation visits (Visits 2-4)
* are willing to use a non-lubricated latex condom (provided) for penile-vaginal intercourse during dosage form evaluation visits (Visits 2-4)
* are willing to undergo HIV testing and receive test results and counseling.
Exclusion Criteria:
Women and men will be ineligible if:
* they are unable or unwilling to give informed consent
* their partner is unable or unwilling to give informed consent
* they are currently enrolled in other vaginal product study/studies
* they are STI (Neisseria gonorrhea, Chlamydia trachomatis, bacterial vaginosis, trichomoniasis, syphilis), HIV positive upon screening (Visit 1A), or pregnant (females) at any study visit
* they are breastfeeding, or have completed menopause (i.e., at least 12 months without menstrual periods) (female participants only)
* they are currently attempting to get pregnant or have an intention to get pregnant during their participation in the study
* they have clinically significant abnormal pelvic findings and/or findings requiring therapy as a function of clinical exam at Visits 1A and/or 1B (female participants only)
* they report being within 30 days of their last pregnancy outcome or gynecologic surgical procedure
* they have known, or suspected, allergies to any component of the study products or similar ingredients in other products
* they have known, or suspected, allergies to latex
* they have any condition that, in the opinion of the study clinician or principle investigator, would compromise the participant´s ability to participate in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01334827
Study Brief:
Protocol Section:
NCT01334827