Status:
COMPLETED
BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study
Lead Sponsor:
University of British Columbia
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
16-50 years
Phase:
PHASE2
PHASE3
Brief 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 infec...
Detailed Description
A minimum of 240 volunteer women will be recruited through participating family practice offices throughout British Columbia. Women with symptoms of BV, who also have a positive whiff test/pH test or ...
Eligibility Criteria
Inclusion
- 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:
- ages 16-50 and premenopausal;
- capable of giving written informed consent;
- English speaking;
- negative pregnancy test on enrolment day;
- agree to follow study protocol;
- documented BV infection by positive vaginal swab +/- positive whiff test/pH \> 4.5;
- agree to no intercourse for the 10 days of treatment (or to use non-lubricated condoms if unavoidable);
- agree not to douche or use any intravaginal products during treatment (including tampons, medications, devices);
- abstain from alcohol during the 10 days of treatment (from 24 hours before through 72 hours after taking study medication);
- agree to no new medications or antibiotics during treatment;
- no current sexually transmitted infection as determined by history, physical exam and negative swabs for chlamydia, gonorrhea, candidiasis, trichomonas;
- patient is reliable for follow up.
Exclusion
- The following women would be excluded from study participation:
- less than 16 or post-menopausal;
- negative vaginal swab regardless of whiff test/pH \> 4.5;
- menstruating at diagnosis;
- symptoms so severe as to make allocation to placebo unacceptable to the patient;
- currently pregnant or at high risk for pregnancy;
- current sexually transmitted infection (HIV, hepatitis, chlamydia, gonorrhea, trichomonas, HPV or HSV);
- current yeast infection as determined by history, physical and swabs;
- history of PID;
- allergy to latex or metronidazole;
- presently lactating;
- any open wound, excoriation, vaginal irritation and including bartholin's cyst/abscess as determined by physical exam;
- presence of another vulvar, vaginal or medical condition, including cervical neoplasia treatment, that might confound treatment response;
- using lithium, anti-coagulants or disulfiram drugs;
- any antifungal or antibiotic use 14 days prior to enrolment
- PAP smear done within one week of enrollment.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00799214
Start Date
April 1 2014
End Date
February 1 2016
Last Update
October 27 2016
Active Locations (1)
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1
Multicentered, family practice offices
Province-wide, British Columbia, Canada