Treatment of Bacterial Vaginosis (BV) With Tinidazole - Full Text View

Sponsor:	University of Alabama at Birmingham
Collaborator:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00334633

Purpose

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

Condition	Intervention	Phase
Bacterial Vaginosis	Drug: tinidazole, metronidazole	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Tinidazole for the Treatment of Bacterial Vaginosis

Resource links provided by NLM:

Drug Information available for: Tinidazole Metronidazole hydrochloride Metronidazole phosphate Metronidazole

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Cure of Bacterial Vaginosis [ Time Frame: one month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Enrollment:	593
Study Start Date:	November 2004
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: control metronidazole 500 BID for 7 days	Drug: tinidazole, metronidazole Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid Other Name: Tindamax, Flagyl
Active Comparator: tinidazole 500 tinidazole 500 BID for 7 days	Drug: tinidazole, metronidazole Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid Other Name: Tindamax, Flagyl
Active Comparator: tinidazole 1 gm tinidazole 1 gm BID for 7 days	Drug: tinidazole, metronidazole Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid Other Name: Tindamax, Flagyl

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334633

Locations

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

Sponsors and Collaborators

University of Alabama at Birmingham

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Jane Schwebke, MD

University of Alabama at Birmingham

More Information

No publications provided

Responsible Party:	Jane Schwebke , MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00334633 History of Changes
Other Study ID Numbers:	F040329003, R01AI058033
Study First Received:	June 7, 2006
Results First Received:	March 3, 2011
Last Updated:	May 24, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Alabama at Birmingham:

bacterial vaginosis
tinidazole

Additional relevant MeSH terms:

Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Metronidazole
Tinidazole
Radiation-Sensitizing Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antitrichomonal Agents

ClinicalTrials.gov processed this record on February 09, 2012