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Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Mission Pharmacal
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00510614
First received: August 1, 2007
Last updated: February 16, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Bacterial Vaginosis
 Drug: tinidazole
Drug: Placebo
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

Resource links provided by NLM:

Drug Information available for: Tinidazole
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence. [ Time Frame: at each study visit ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: October 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
1 gram tinidazole twice weekly for 12 weeks
 Drug: tinidazole
1 gram twice weekly for 12 weeks
Other Name: Tindamax
Placebo Comparator: B
Placebo twice weekly for 12 weeks
 Drug: Placebo
one pill twice weekly for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510614

Locations
United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Mission Pharmacal
Investigators
Principal Investigator: Richard Beigi, MD, MSc. Magee-Womens Hospital of UPMC
  More Information

No publications provided

Responsible Party: Richard H Beigi, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00510614     History of Changes
Other Study ID Numbers: PRO07030019
Study First Received: August 1, 2007
Last Updated: February 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Bacterial Vaginosis
Recurrent Bacterial Vaginosis

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Tinidazole
Alkylating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013