Treatment of Bacterial Vaginosis (BV) With Tinidazole

Phase 4

Completed

Conditions: Bacterial Vaginosis

Interventions: Drug: tinidazole, metronidazole

Registration Number: NCT00334633

Lead Sponsor: University of Alabama at Birmingham

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 593

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	tinidazole, metronidazole	metronidazole 500 BID for 7 days
tinidazole 500	tinidazole, metronidazole	tinidazole 500 BID for 7 days
tinidazole 1 gm	tinidazole, metronidazole	tinidazole 1 gm BID for 7 days

Primary Outcome Measures