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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 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: July 21, 2015
Last verified: July 2015
  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.

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%.


Condition Intervention Phase
Bacterial Vaginosis
Drug: Placebo
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:
  • 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 [ Time Frame: day 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: day 17 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: day 40 ] [ Designated as safety issue: No ]
  • Safety consideration including intolerable adverse effects requiring patient discontinuation of the 10 day treatment [ Time Frame: day 1-10 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: April 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
1 gram emollient cream to be inserted intravaginally qhs (once before bed) for 10 days or less if intolerable side effects occur.
Drug: Placebo
1 gram emollient cream 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 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
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.
Active Comparator: 3
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
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.

  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: Melinda Zeron Mullins, MD, Ph.D 250-818-5059 melindazeron@hotmail.com
Contact: Konia Trouton, MD 250-480-7338 ktrouton@yahoo.com

Locations
Canada, British Columbia
Multicentered, family practice offices Recruiting
Province-wide, British Columbia, Canada
Contact: Melinda Zeron Mullins, MD, Ph.D    250-818-5059    melindazeron@hotmail.com   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Konia Trouton, MD University of British Columbia
Principal Investigator: Melinda Zeron Mullins, MD, Ph.D University of British Columbia
  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: July 21, 2015
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginitis
Emollients
Metronidazole
Tetrahydrozoline
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Autonomic Agents
Cardiovascular Agents
Dermatologic 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 July 28, 2015