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Treatment of Bacterial Vaginosis (BV) With Tinidazole

NCT ID: NCT00334633

Last Updated: 2017-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

593 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Bacterial Vaginosis

Keywords

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bacterial vaginosis tinidazole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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control

metronidazole 500 BID for 7 days

Group Type ACTIVE_COMPARATOR

tinidazole, metronidazole

Intervention Type DRUG

Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

tinidazole 500

tinidazole 500 BID for 7 days

Group Type ACTIVE_COMPARATOR

tinidazole, metronidazole

Intervention Type DRUG

Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

tinidazole 1 gm

tinidazole 1 gm BID for 7 days

Group Type ACTIVE_COMPARATOR

tinidazole, metronidazole

Intervention Type DRUG

Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

Interventions

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tinidazole, metronidazole

Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

Intervention Type DRUG

Other Intervention Names

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Tindamax, Flagyl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Jane Schwebke

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jane Schwebke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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Jefferson County Department of Health STD Clinic

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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R01AI058033

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F040329003

Identifier Type: -

Identifier Source: org_study_id