Clinical trial: A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom (NCT01223313)

Eligibility criteria:
Inclusion Criteria

        To enroll into the clinical trial, potential subjects must:

          1. Be healthy women, who are sexually active, at risk for pregnancy and desiring
             contraception.

          2. Be within the age range of 18 through 40 years inclusive at enrollment.

          3. Have a negative urine pregnancy test at the admission visit.

          4. Have a history of regular cyclic menses with a usual length of 21 to 35 days when not
             using hormonal contraception.

          5. Have one menses after switching from oral contraceptives to using the Woman's Condom.

          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. Be willing to engage in 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 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 diary to record coital information, product use information,
             information about the use of other vaginal products, and any symptoms, which occurred
             in her or her partner over the course of study participation.

         13. Be willing to state that, to her best knowledge, her sexual partner(s):

               1. Has not had a vasectomy or been previously diagnosed as infertile.

               2. Has not been previously diagnosed or suspected of HIV unless he has subsequently
                  had a negative HIV test.

               3. Has not been known to have engaged in homosexual intercourse in the past 5 years
                  unless he has had negative HIV test results since then.

               4. Has not shared injection drug needles in the past unless he has had a negative
                  HIV test at least 6 weeks since last use.

               5. Has no known history of allergy or sensitivity to polyurethane (condom pouch),
                  polyvinyl alcohol (capsule), or other water-based lubricants such as Astroglide.

         14. Agree not to participate in any other clinical trials during the course of this study.

         15. Be willing to give written informed consent to participate in the trial.

        Exclusion Criteria

        To enroll into the clinical trial, potential subjects must not:

          1. Have a history of allergy or sensitivity to polyurethane (condom pouch), polyvinyl
             alcohol (capsule), or other water-based lubricants such as Astroglide.

          2. Have current UTI or symptomatic vaginal infection as confirmed by dipstick urinalysis,
             or if needed by a urine culture or wet mount (see Schedule of Assessments for
             definitions), unless treated and proof of cure is documented by a negative test result
             performed at least 2 weeks post-treatment.

          3. Have evidence of Chlamydia trachomatis or Neisseria gonorrhea infection unless she and
             her partner(s) complete treatment and proof of cure is documented for the subject only
             by a negative test result performed at least 3 weeks post-treatment.

          4. Be pregnant, have a suspected pregnancy or desire to become pregnant during the course
             of the study.

          5. Have a history of infertility or pelvic inflammatory disease without a subsequent
             spontaneous intrauterine pregnancy.

          6. Have been diagnosed with pelvic inflammatory disease (PID) without a subsequent
             intrauterine pregnancy.

          7. Be in a monogamous relationship of less than 4 months with their partner.

          8. Have any contraindications to pregnancy (medical condition) or regularly use category
             D or X or exclusionary medications listed in Appendix F.

          9. Have shared injection drug needles in the past unless has a negative HIV test at least
             6 weeks since last use.

         10. Have known or suspected to have an HIV infection.

         11. 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.

         12. Be lactating or breastfeeding.

         13. Have any clinically significant abnormal vaginal bleeding or spotting within the month
             prior to screening.

         14. Have had vaginal or cervical biopsy or vaginal surgery within 3 months prior to
             screening.

         15. Have used vaginal or systemic antibiotics or antifungal agents within 14 days prior to
             screening or enrollment.

         16. Have received a Depo-Provera® injection in the 9 months prior to enrollment (this
             exclusionary time period can be shortened to 6 months if the subject has also had 2
             spontaneous menstrual cycles [requires minimum of 3 menses] that meet criteria for
             normal menstrual cycles).

         17. Have an abnormal Pap test based on the following criteria:

               -  Pap test in the past 15 months with ASC-US unless:

                    -  less than 21 years of age;

                    -  a repeat Pap test at least 6 months later was normal;

                    -  reflex HPV testing was performed and was negative for high-risk HPV; or

                    -  a colposcopy (with or without biopsy) found no evidence of dysplasia
                       requiring treatment or treatment was performed and follow-up at least 6
                       months after the treatment showed no evidence of disease;

               -  Pap test in the past 15 months with LSIL unless:

                    -  less than 21 years of age;

                    -  a colposcopy (with or without biopsy) found no evidence of dysplasia
                       requiring treatment or treatment was performed and follow-up at least 6
                       months after the treatment showed no evidence of disease;

               -  Pap test in the past 15 months with ASC-H, atypical glandular cells, or HSIL
                  unless colposcopy and/or treatment was performed and follow-up at least 6 months
                  after the colposcopy and/or treatment showed no evidence of disease;

               -  Pap test in the past 15 months with malignant cells.

         18. Have a past (within 12 months) or current history of alcohol or drug [recreational,
             prescription or over-the-counter (OTC)] abuse.

         19. Have taken an investigational drug or used an investigational device within the past
             30 days.

         20. Have previously participated in or completed this study.

         21. 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. For example, if the subject is found to have Condyloma
             Accuminata, the investigator can decide whether to exclude the subject or not,
             depending on its location and if use of the condom may be painful for the subject.
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