Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

February 16, 2011 updated by: University of Pittsburgh

This research study is being done to evaluate the use of an oral (by mouth) medication called tinidazole to initially treat BV and then to see if additional treatment with tinidazole keeps women from getting this infection back within 3 months. Tinidazole is currently approved by the United States Food and Drug Administration (FDA) to treat bacterial vaginosis (BV).

This study will evaluate the use of tinidazole to treat a woman's current BV infection and then will look at using tinidazole as a suppressive treatment (taking medication regularly to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment phase will include using tinidazole twice a week compared to using placebo twice a week and then following women for recurrence of BV. The purpose of this study is to determine if tinidazole suppression will prevent BV from coming back within 3 months of treatment.

The investigators hypothesize that women with a history of recurrent bacterial vaginosis who are randomized to a suppressive regimen (a dose of medication given on a regular basis to attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared to those women randomized to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Magee-Womens Hospital of UPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age 18-45 at time of enrollment.

  2. Recurrent BV as defined by:

    • 2 previously documented diagnoses of BV in the past 6 months or
    • 3 previously documented diagnoses of BV in the past year
  3. Non-pregnant, non-lactating.
  4. Premenopausal.

  5. Presence of bacterial vaginosis at the enrollment visit using Amsel Criteria (at least 3 of 4):

    • Presence of homogenous vaginal discharge
    • pH of vaginal secretions of > 4.7
    • Presence of a positive "whiff" test of the vaginal secretions upon mixing with 10% KOH
    • Presence of > 20% clue cells on saline microscopy
  6. Willingness to undergo randomization to a possible placebo arm (for suppressive therapy).
  7. Ability to undergo informed consent.
  8. Willingness to refrain from use of any intravaginal products (including douching, contraceptive spermicides, creams, gels, foams).
  9. Currently using an acceptable method of birth control (such as a hormonal method including oral contraceptives, Depo Provera, Ortho Evra, abstinence x 60 days, consistent condom use, surgically sterile, lesbian orientation).
  10. Willing to refrain from alcohol consumption during use of study medication and three days following completion of medication (which includes the 10 day open label treatment and the entire 3 month suppressive phase of treatment).

Exclusion Criteria:

  1. Known active sexually transmitted infection at the time of enrollment with C. trachomatis, N. gonorrhoeae, T. vaginalis, or active (symptomatic) vulvovaginal candidiasis.
  2. Current use of anticoagulants/blood thinners (i.e. warfarin, coumadin, heparin).
  3. Current use of any of the following medications: lithium, fluorouracil, anticonvulsant/seizure medications, Questran (cholestyramine) or CYP3A4 inducer/inhibitors (i.e. phenobarbital, rifampin, phenytoin, fosphenytoin).
  4. Use of Antabuse (disulfiram) currently or within the past 2 weeks.
  5. Allergy to metronidazole or tinidazole (related drugs with likely cross-over allergy potential).
  6. Use of any antibiotics (oral or vaginal) in the past 7 days.
  7. Current use of an IUD, Nuva Ring.
  8. Known immunosuppressive condition (i.e. HIV, end-stage renal disease, currently-treated diabetes mellitus, etc.) or on immunosuppressive medications [i.e. steroids, cyclosporine, Protopic (tacrolimus), immunomodulators].
  9. Participation in an investigational drug study within the past 30 days.
  10. Any condition which in the opinion of the investigator would impose a health risk to the subject or interfere with the evaluation of the study medication or procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
1 gram tinidazole twice weekly for 12 weeks
Drug: tinidazole
1 gram twice weekly for 12 weeks
Other Names:
  • Tindamax
Placebo Comparator: B
Placebo twice weekly for 12 weeks
Drug: Placebo
one pill twice weekly for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test.
Time Frame: at each study visit
at each study visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence.
Time Frame: at each study visit
at each study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Mission Pharmacal

Investigators

  • Principal Investigator: Richard Beigi, MD, MSc., University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 1, 2007

First Submitted That Met QC Criteria

August 1, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

February 18, 2011

Last Update Submitted That Met QC Criteria

February 16, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO07030019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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