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 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? Contradiction