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

NCT00799214 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-10-27

No results posted yet for this study

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%.

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

Placebo

1 gram emollient cream to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.

DRUG

Boric acid

Boric acid = 600 mg boric acid compounded in emollient cream (1 gram total) to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.

DRUG

Metronidazole

Metronidazole = 10 % intravaginal cream (Sanofi-Aventis Canada Inc Product DIN 01926861) (for a total of 37.5 mg metronidazole) to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Konia Trouton, MD · University of British Columbia

  • Melinda Zeron Mullins, MD, Ph.D · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-11-30
Completion
2016-02-29

Countries

  • Canada

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799214 on ClinicalTrials.gov