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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT04233632
Eligibility Criteria:
Inclusion Criteria:
1. Healthy sexually active women who have ever used an FC and using condoms (male or female) as their current method of contraception.
2. Be 18 to 40 years at enrolment (inclusive).
3. Have a negative urine pregnancy test at enrolment visit.
4. Is HIV negative
5. Have a history of regular cyclic menses (usual length of 21 to 35 days) when not using hormonal contraception.
6. Have at least one spontaneous menstrual cycle (two menses) following a pregnancy that ended at 14 or more weeks gestation.
7. Have at least one cycle (two menses) after an abortion at less than 14 weeks gestation.
8. Be willing to accept a risk of pregnancy.
9. Reporting to have at least four acts of heterosexual vaginal intercourse per month for a period of 6 months.
10. Be willing to only use the study product (Cupid or FC2 female condom) as the primary method of contraception over the course of the study.
11. Be capable of using the study product properly and agree to observe all study directions and requirements.
12. Be willing to keep a daily diary to record menstrual pattern, acts of intercourse, and details of condom use and any condom failures.
13. Be willing to state that, to her best knowledge, her sexual partner:
* Has not had a vasectomy or been previously diagnosed as infertile.
* Is HIV negative
* Has no known history of allergy or sensitivity to natural rubber latex, water-based or silicone lubricants
* Does not want her to become pregnant in the next 7 months
14. Agree to have fingerprint identity check
15. Be willing to give written informed consent to participate in the trial.
16. Intend to stay in the area for the next 6-7 months
17. Be willing to be randomized
Exclusion Criteria:
1. Have a history of allergy or sensitivity to rubber latex or water-based /silicone lubricants
2. Have evidence of sexually transmitted infections on syndromic assessment and / or vaginal examination
3. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course of the study.
4. Have a history of infertility or pelvic inflammatory disease without a subsequent spontaneous intrauterine pregnancy.
5. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent intrauterine pregnancy.
6. Be in a monogamous relationship of less than 4 months with their partner.
7. Have any contraindications to pregnancy (medical condition) or regularly use medications that are unsafe to use in pregnancy
8. Have shared injection drug needles in the past unless has a negative HIV test at least 6 weeks since last use.
9. HIV positive.
10. Have been diagnosed with genital herpes simplex virus (HSV), with the first occurrence (initial episode) within 3 months prior to screening or have clinical evidence of HSV on exam.
11. Be lactating or breastfeeding.
12. Have any clinically significant abnormal vaginal bleeding or spotting within the month prior to screening.
13. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to screening.
14. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to screening or enrollment.
15. Have received a Depo-Provera® injection in the 6 months prior to enrolment or Nur-Isterate in the last 4 months prior to enrolment
16. Have a past (within 12 months) or current history of alcohol or drug \[recreational, prescription or over-the-counter (OTC)\] abuse.
17. Have taken an investigational drug or used an investigational device within the past 30 days.
18. Have issues or concerns (in the judgment of the investigator) that may compromise the safety of the subject or confound the reliability of compliance and information acquired in this study.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04233632
Study Brief:
Protocol Section:
NCT04233632