BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

Bacterial vaginosis (BV), the world's most common vaginal infection, continues to cost patients time, energy, comfort and money. BV is associated with increased incidence of sexually transmitted infections (including HIV), spontaneous abortion, pre-term labour, post-surgical infections, and endometritis. Current treatment for those women symptomatic for BV includes both oral and intravaginal antibiotics, such as metronidazole, which have success rates of 70-80 % at 1 month after treatment. These treatments also have high recurrence rates (49-66 % at one year after treatment) and side effects (10-20 % of women) that include secondary vaginal infection with candida. Intravaginal boric acid has been used for >100 years for the treatment of vaginal infections and is quite commonly prescribed today as a treatment for BV. It is cheap, easily accessible, easy to use, and is an effective treatment of other vaginal infections, such as candida. To date, there are no clinical trials studying the effectiveness of boric acid in the treatment of BV.

The objective of this study was to determine whether intravaginal BA is comparable to standard treatment, metronidazole, for the cure of BV in symptomatic women.

Our research question is: Among women 16-50 years old symptomatic with BV is intravaginal treatment with BA non-inferior to metronidazole to achieve a Nugent score <7 (cure) by day 17.

Hypothesis: H0: BA proportion of women cured < metronidazole proportion of women cured - 10%.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Treatments: Emollients; Metronidazole; Tetrahydrozoline

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.