Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

NCT00510614 | Completed Early Phase 1 DMC

• 1 other identifier: PRO07030019
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Keywords

Bacterial Vaginosis; Recurrent Bacterial Vaginosis

Outcome Measures

Primary Outcomes (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.

  at each study visit

Secondary Outcomes (1)

• Kaplan-Meier product-limit estimation will be used to obtain estimates of the median time to BV recurrence.

  at each study visit

Study Arms (2)

A

ACTIVE COMPARATOR

1 gram tinidazole twice weekly for 12 weeks

Drug: tinidazole

B

PLACEBO COMPARATOR

Placebo twice weekly for 12 weeks

Drug: Placebo

Interventions

tinidazole DRUG

1 gram twice weekly for 12 weeks

Also known as: Tindamax

A

Placebo DRUG

one pill twice weekly for 12 weeks

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 at time of enrollment.
• Recurrent BV as defined by:
• previously documented diagnoses of BV in the past 6 months or
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Mission Pharmacal: collaborator

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Tinidazole

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Richard Beigi, MD, MSc.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 18, 2011

Record last verified: 2011-02

Locations

US (1)