Clinical trial: Randomized Comparative Study of the Contraceptive Efficacy of the Cupid, Cupid 2 and FC2 Female Condom (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.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment