Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

Inclusion criteria

• Age 18-45 at time of enrollment.
• 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
• Non-pregnant, non-lactating.
• Premenopausal.
• 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
• Willingness to undergo randomization to a possible placebo arm (for suppressive therapy).
• Ability to undergo informed consent.
• Willingness to refrain from use of any intravaginal products (including douching, contraceptive spermicides, creams, gels, foams).
• 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).
• 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

• Known active sexually transmitted infection at the time of enrollment with C. trachomatis, N. gonorrhoeae, T. vaginalis, or active (symptomatic) vulvovaginal candidiasis.
• Current use of anticoagulants/blood thinners (i.e. warfarin, coumadin, heparin).
• 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).
• Use of Antabuse (disulfiram) currently or within the past 2 weeks.
• Allergy to metronidazole or tinidazole (related drugs with likely cross-over allergy potential).
• Use of any antibiotics (oral or vaginal) in the past 7 days.
• Current use of an IUD, Nuva Ring.
• 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].
• Participation in an investigational drug study within the past 30 days.
• 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.