Clinical trial: Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel (NCT02309554)

Eligibility criteria:
Inclusion Criteria:

          1. Age 18-45 years, inclusive

          2. General good health, by volunteer history and per investigator judgment

          3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report

          4. History of Pap smears and follow-up consistent with standard medical practice as
             outlined in the Study Manual or willing to undergo a Pap smear at Visit 1

          5. Willing to abstain from intercourse and use of vaginal products as required in the
             protocol

          6. Willing to use non-spermicidal, lubricated condoms from the first day of each
             menstrual cycle until 72 hours before expected midcycle

          7. In a mutually monogamous relationship for at least the last four months with a male
             partner who: 7a. Is at least 18 years old; 7b. Has no known risk for STIs; 7c. Is
             willing and able to comply with protocol requirements including sexual activity/
             abstinence and condom use requirements; and 7d. Can engage in vaginal intercourse with
             the participant, with and without condoms, as specified in protocol

          8. Protected from pregnancy by female tubal sterilization

          9. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
             easy genital tract sample collection

         10. Willing to give voluntary consent, sign an informed consent form and comply with study
             procedures as required by the protocol

        Exclusion Criteria:

          1. History of hysterectomy

          2. Vasectomy in male partner

          3. Sterility or known history of sperm dysfunction in male partner

          4. Currently pregnant or within two calendar months from the last pregnancy outcome.
             Note: If recently pregnant must have had at least two spontaneous menses since
             pregnancy outcome

          5. Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera in
             the last 120 days

          6. Currently breastfeeding or having breastfed an infant in the last two months, or
             planning to breastfeed during the course of the study

          7. Significant gynecological abnormalities (including abnormal vaginal bleeding or
             excessive vaginal discharge)

          8. Device does not appropriately fit volunteer, as determined by clinician

          9. Inability to insert, position, and/or remove study device, by clinician or volunteer

         10. History of sensitivity/allergy to 3% N-9, latex, ingredients in ContraGel, or
             silicone, for either the volunteer or her male partner

         11. In the last six months, either the volunteer or her male partner diagnosed with or
             treated for any STI or pelvic inflammatory disease. Note: Women with a history of
             genital herpes or condylomata who have been asymptomatic for at least six months may
             be considered for eligibility

         12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea or Chlamydia trachomatis

         13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
             vesicles suspicious for a sexually transmitted infection

         14. Positive test for HIV

         15. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)

         16. Known current drug or alcohol abuse which could impact study compliance

         17. Participation in any other investigational trial within the last 30 days or planned
             participation in any other investigational trial during the study

         18. History of gynecological procedures (including genital piercing) on the external
             genitalia, vagina or cervix within the last 14 days

         19. Abnormal finding on laboratory or physical examination or a social or medical
             condition in either the volunteer or her male partner which, in the opinion of the
             investigator, would make participation in the study unsafe or would complicate
             interpretation of data
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 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? 0