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

August 1, 2007
February 16, 2011
October 2007
September 2009   (final data collection date for primary outcome measure)
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 ]
Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test.
Complete list of historical versions of study NCT00510614 on ClinicalTrials.gov Archive Site
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 ]
Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence.
Not Provided
Not Provided
 
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

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.

Not Provided
Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Bacterial Vaginosis
  • Drug: tinidazole
    1 gram twice weekly for 12 weeks
    Other Name: Tindamax
  • Drug: Placebo
    one pill twice weekly for 12 weeks
  • Active Comparator: A
    1 gram tinidazole twice weekly for 12 weeks
    Intervention: Drug: tinidazole
  • Placebo Comparator: B
    Placebo twice weekly for 12 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510614
PRO07030019
Yes
Richard H Beigi, MD, University of Pittsburgh
University of Pittsburgh
Mission Pharmacal
Principal Investigator: Richard Beigi, MD, MSc. Magee-Womens Hospital of UPMC
University of Pittsburgh
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP