Treatment of BV With Tinidazole - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 7, 2006

Last Updated Date

December 20, 2007

Start Date ^†

November 2004

Current Primary Outcome Measures ^†

cure of BV [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00334633 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

recurrence of BV [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Treatment of BV With Tinidazole

Official Title ^†

Tinidazole for the Treatment of Bacterial Vaginosis

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:

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
To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV
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.

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study

Condition ^†

Bacterial Vaginosis

Intervention ^†

Drug: tinidazole

Study Arms / Comparison Groups

Active Comparator: metronidazole 500 BID for 7 days
Active Comparator: tinidazole 500 BID for 7 days
Active Comparator: tinidazole 1 gm BID for 7 days

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

500

Estimated Completion Date

June 2008

Primary Completion Date

Eligibility 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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Joy Lewis	205-996-2780
Contact: Jane Schwebke, MD	205-975-5665	schwebke@uab.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00334633

Responsible Party

Jane Schwebke , MD, University of Alabama at Birmingham

Secondary IDs ^††

R01AI058033

Study Sponsor ^†

University of Alabama at Birmingham

Collaborators ^††

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators ^†

Principal Investigator:

Jane Schwebke, MD

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.