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

NCT00799214 | Completed Phase 2

• 1 other identifier: H07-02330
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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

Keywords

bacterial vaginosis; intravaginal; boric acid; metronidazole; placebo controlled; double-blind; randomized; multicenter; non-inferiority

Outcome Measures

Primary Outcomes (1)

• Non-inferiority, per protocol comparison of effectiveness of boric acid to metronidazole at day 17 as measured by Nugent score in 16-50 year olds with a z-based confidence interval for the difference of two proportions

  day 17

Secondary Outcomes (3)

• Non-inferiority, intent-to-treat comparison of effectiveness of boric acid to metronidazole at day 17 as measured by Nugent score in 16-50 year olds with a z-based confidence interval for the difference of two proportions

  day 17

• Non-inferiority, comparison of effectiveness of boric acid to metronidazole at day 40 as measured by Nugent score in 16-50 years old analyzed both per protocol and intent-to treat with a z-based confidence interval for the difference of two proportions

  day 40

• Safety consideration including intolerable adverse effects requiring patient discontinuation of the 10 day treatment

  day 1-10

Study Arms (3)

1

PLACEBO COMPARATOR

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

Drug: Placebo

2

EXPERIMENTAL

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: Boric acid

3

ACTIVE COMPARATOR

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

Drug: Metronidazole

Interventions

Placebo DRUG

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

1

Boric acid DRUG

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.

2

Metronidazole DRUG

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.

3

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Multicentered, family practice offices

Province-wide, British Columbia, Canada

Location

Related Publications (1)

• Zeron Mullins M, Trouton KM. BASIC study: is intravaginal boric acid non-inferior to metronidazole in symptomatic bacterial vaginosis? Study protocol for a randomized controlled trial. Trials. 2015 Jul 26;16:315. doi: 10.1186/s13063-015-0852-5.

  PMID: 26210791 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

boric acid; Metronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Konia Trouton, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Melinda Zeron Mullins, MD, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 27, 2008
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: February 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

CA (1)