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Treatment of Bacterial Vaginosis (BV) With Tinidazole

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Vaginosis

Intervention: tinidazole, metronidazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Jane Schwebke, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham

Summary

We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole

Clinical Details

Official title: Tinidazole for the Treatment of Bacterial Vaginosis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Cure of Bacterial Vaginosis

Secondary outcome: Recurrence of BV

Detailed description: Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the U. S. and has been associated with complications including preterm delivery of infants, pelvic inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of BV has been advocated as a means of decreasing the prevalence of these complications. However, the etiology of BV remains unknown and the current treatment regimens are inadequate in terms of initial cure and recurrence rates. Although not currently licensed in the U. S., tinidazole is an antimicrobial related to metronidazole which has shown promise for the treatment of BV in European studies and is widely used worldwide for the treatment of trichomoniasis including infections which are resistant to metronidazole. We hypothesize that qualities of tinidazole such as its longer half-life and its seemingly superior side effect profile as compared to oral metronidazole will result in its being a more efficacious drug for the treatment of BV than the currently available options. The specific aims of this project are: 1. To compare the efficacy of two different doses of tinidazole with oral metronidazole for the initial treatment of symptomatic BV as well as short-term recurrence rates 2. To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV 3. To compare drug levels of tinidazole and metronidazole in the vaginal secretions and correlate with microbiologic cure of BV as well as rates of recurrence.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women be at least 18 years of age

- Have symptoms of vaginal odor and or/discharge

- Meet the clinical (Amsel) criteria for BV

- Willing to participate in research

Exclusion Criteria:

- Presence of another vaginal infection or STD

- Allergy to metronidazole

- Pregnant or nursing

- Use of oral or intravaginal antibiotics within the past 2 weeks

- HIV or other chronic disease

- Inability to keep return appointments

Locations and Contacts

Jefferson County Department of Health STD Clinic, Birmingham, Alabama 35294, United States
Additional Information

Starting date: November 2004
Last updated: May 24, 2011

Page last updated: August 23, 2015

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