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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00799214
First received: November 10, 2008
Last updated: September 8, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Effectiveness of treatment of intravaginal boric acid and metronidazole at 1 week and 30 days post-treatment will be measured as absence of symptoms or negative vaginal swab (Nugent score less than 7) if symptoms are present for BV. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • If during the 10 days of treatment of intravaginal boric acid and metronidazole the patient discontinues the treatment because of side effects or complained of intolerable side effects this will be considered a treatment failure for safety. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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.
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.
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.
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.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799214

Contacts
Contact: Teresa Wood, MD 250-388-2180 onmybicycle@yahoo.com
Contact: Melinda Zeron Mullins 250 818 5059 melindazeron@hotmail.com

Locations
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   
Sponsors and Collaborators
University of British Columbia
Investigators
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

No publications provided

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: September 8, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
bacterial vaginosis
intravaginal
boric acid
metronidazole
placebo controlled
double-blind
randomized
multicenter

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginal Diseases
Vaginitis
Metronidazole
Tetrahydrozoline
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Autonomic Agents
Cardiovascular Agents
Nasal Decongestants
Ophthalmic Solutions
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 30, 2014