Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510614
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : February 18, 2011
Mission Pharmacal
Information provided by:
University of Pittsburgh

Brief Summary:

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 or disease Intervention/treatment Phase
Bacterial Vaginosis Drug: tinidazole Drug: Placebo Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
Study Start Date : October 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases
Drug Information available for: Tinidazole

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510614

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

Responsible Party: Richard H Beigi, MD, University of Pittsburgh Identifier: NCT00510614     History of Changes
Other Study ID Numbers: PRO07030019
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: February 18, 2011
Last Verified: February 2011

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

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