Clinical trial: Safety and Acceptability Study of a Non-Hormonal Ring (NCT03598088)

Eligibility criteria:
Inclusion Criteria:

          1. Women aged 18-50 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 tests and follow-up consistent with standard medical practice or
             willing to undergo a Pap test at Visit 1.

          5. Protected from pregnancy by female tubal sterilization

          6. Willing to abstain from or engage in intercourse with and without condoms and to
             abstain from other vaginal activity as required in the protocol

          7. In a mutually monogamous relationship for at least the last four months with a male
             partner who:

               1. Is at least 18 years old;

               2. Has no known risk for STIs;

               3. Is willing and able to comply with protocol requirements including sexual
                  activity/ abstinence and condom use requirements; and

               4. Can engage in vaginal intercourse with the participant, with and without condoms,
                  as specified in protocol

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

          9. 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. 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
             within 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. Either device does not appropriately fit volunteer, as determined by clinician

          9. Inability of the volunteer to insert, position, and/or remove either device, even with
             assistance

         10. History of sensitivity/allergy to nonoxynol-9 or to silicone or any other component of
             Ovaprene™ or Caya, for either the volunteer or her male partner

         11. In the last four months, either the volunteer or her male partner diagnosed with or
             treated for any STI or pelvic inflammatory disease. Note: Women or male partners 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, Chlamydia trachomatis,
             or HIV

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

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

         15. Known current drug or alcohol abuse which could impact study compliance. (This is
             defined as any illicit drug use or more than 15 alcoholic drinks per week)

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

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

         18. 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

         19. Nugent score greater than or equal to 7

         20. Systemic use in the last two weeks or anticipated use during the study of antibiotics
             (other than those used to treat UTI, vaginal candidiasis, or BV diagnosed at Visit 1,
             or to treat UTI or vaginal candidiasis after Visit 1) or topical antivirals (e.g.,
             acyclovir or valacyclovir). Note: Participants should avoid non-steroidal
             anti-inflammatory drugs (NSAIDs) and Tylenol except for occasional use, as in
             treatment of headaches or dysmenorrhea.

         21. Grade 2 or higher abnormality per the March 2017 update of the Division of AIDS
             (DAIDS), National Institute of Allergy and Infectious Disease (NIAID) Table for
             Grading of the Severity of Adverse Events or clinically significant lab abnormalities
             as determined by the investigator (see Section 13.5 for link to DAIDS table)

         22. Inability to achieve adequate cervical mucus in two attempts at the baseline cycle

         23. Inadequate sperm in endocervical aspirate during baseline testing without any device,
             despite adequate mucus and presence of sperm in vaginal pool
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 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