Clinical trial: BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study (NCT00799214)

Eligibility criteria:
Inclusion Criteria:

        Women will be included whether their complaint is symptoms of BV and have a positive whiff
        test/vaginal swab or if they have a positive whiff test/vaginal swab and are then asked if
        they have any symptoms of BV present. The following criteria must be met for enrolment in
        the study:

          1. ages 16-50 and premenopausal;

          2. capable of giving written informed consent;

          3. English speaking;

          4. negative pregnancy test on enrolment day;

          5. agree to follow study protocol;

          6. documented BV infection by positive vaginal swab +/- positive whiff test/pH > 4.5;

          7. agree to no intercourse for the 10 days of treatment (or to use non-lubricated condoms
             if unavoidable);

          8. agree not to douche or use any intravaginal products during treatment (including
             tampons, medications, devices);

          9. abstain from alcohol during the 10 days of treatment (from 24 hours before through 72
             hours after taking study medication);

         10. agree to no new medications or antibiotics during treatment;

         11. no current sexually transmitted infection as determined by history, physical exam and
             negative swabs for chlamydia, gonorrhea, candidiasis, trichomonas;

         12. patient is reliable for follow up.

        Exclusion Criteria:

        The following women would be excluded from study participation:

          1. less than 16 or post-menopausal;

          2. negative vaginal swab regardless of whiff test/pH > 4.5;

          3. menstruating at diagnosis;

          4. symptoms so severe as to make allocation to placebo unacceptable to the patient;

          5. currently pregnant or at high risk for pregnancy;

          6. current sexually transmitted infection (HIV, hepatitis, chlamydia, gonorrhea,
             trichomonas, HPV or HSV);

          7. current yeast infection as determined by history, physical and swabs;

          8. history of PID;

          9. allergy to latex or metronidazole;

         10. presently lactating;

         11. any open wound, excoriation, vaginal irritation and including bartholin's cyst/abscess
             as determined by physical exam;

         12. presence of another vulvar, vaginal or medical condition, including cervical neoplasia
             treatment, that might confound treatment response;

         13. using lithium, anti-coagulants or disulfiram drugs;

         14. any antifungal or antibiotic use 14 days prior to enrolment

         15. PAP smear done within one week of enrollment.
Female
Accepts Healthy Volunteers
Subject must be at least 16 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? 0