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| Sponsor: | University of British Columbia |
|---|---|
| Information provided by (Responsible Party): | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00799214 |
Purpose
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.
Objectives: To determine whether boric acid is at least as effective and as safe as metronidazole for treating women with symptomatic BV, our study will compare intravaginal boric acid to the current standard intravaginal treatment, metronidazole, and to a placebo. Our goal is to expand women's options for the treatment of BV. Hypothesis: Boric acid is an effective treatment of bacterial vaginosis as compared to placebo. Boric acid is at least as effective and as safe in the treatment of bacterial vaginosis as compared to metronidazole.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Vaginosis |
Drug: Gelatin Drug: Boric acid Drug: Metronidazole |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Back to BASICS: Boric Acid, Alternate Solution for Intravaginal Colonization, Comparing Intravaginal Metronidazole to Boric Acid in Women Symptomatic for Bacterial Vaginosis |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Gelatin-filled size 0 gelatin capsules to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
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Drug: Gelatin
Gelatin-filled size 0 gelatin capsules to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
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Experimental: 2
Boric acid = 600 mg boric acid in size 0 gelatin capsules to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
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Drug: Boric acid
Boric acid = 600 mg boric acid in size 0 gelatin capsules to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
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|
Active Comparator: 3
Metronidazole = 37.5 mg metronidazole in size 0 gelatin capsules to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
|
Drug: Metronidazole
Metronidazole = 37.5 mg metronidazole in size 0 gelatin capsules to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 16 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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:
Exclusion Criteria:
The following women would be excluded from study participation:
Contacts and Locations| Contact: Teresa Wood, MD | 250-388-2180 | onmybicycle@yahoo.com |
| Contact: Melinda Zeron Mullins | 250 818 5059 | melindazeron@hotmail.com |
| Canada, British Columbia | |
| Multicentered (family practice offices, gyneological offices, STI Clinic, Sexual Health Clinic, and Youth Clinics in Victoria, BC) | Recruiting |
| Victoria, British Columbia, Canada | |
| Contact: Teresa Wood, MD 250-388-2180 onmybicycle@yahoo.com | |
| Principal Investigator: | Teresa Wood, MD | University of British Columbia |
| Principal Investigator: | Konia Trouton, MD | University of Victoria |
| Principal Investigator: | Melinda Zeron Mullins | University of Victoria |
More Information
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00799214 History of Changes |
| Other Study ID Numbers: | H07-02330 |
| Study First Received: | November 10, 2008 |
| Last Updated: | April 24, 2012 |
| Health Authority: | Canada: Health Canada |
|
bacterial vaginosis intravaginal boric acid metronidazole |
placebo controlled double-blind randomized multicenter |
|
Vaginosis, Bacterial Bacterial Infections Vaginitis Vaginal Diseases Genital Diseases, Female Metronidazole Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents |