Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Vaginosis
Intervention: tinidazole (Drug); Placebo (Drug)
Phase: Phase 0
Status: Completed
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Richard Beigi, MD, MSc., Principal Investigator, Affiliation: Magee-Womens Hospital of UPMC
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.
Clinical Details
Official title: Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Differences in the proportion of women clinically cured at each visit between the two therapy arms will be evaluated using Fisher's-exact test.
Secondary outcome: Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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.
Locations and Contacts
Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania 15213, United States
Additional Information
Starting date: October 2007
Last updated: February 16, 2011
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