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Sponsors and Collaborators: |
University of Alabama at Birmingham National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00334633 |
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 |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Tinidazole for the Treatment of Bacterial Vaginosis |
Estimated Enrollment: | 500 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | June 2008 |
Arms | Assigned Interventions |
---|---|
control: Active Comparator
metronidazole 500 BID for 7 days
|
Drug: tinidazole
see above
|
tinidazole 500: Active Comparator
tinidazole 500 BID for 7 days
|
Drug: tinidazole
see above
|
tinidazole 1 gm: Active Comparator
tinidazole 1 gm BID for 7 days
|
Drug: tinidazole
see above
|
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:
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joy Lewis | 205-996-2780 | |
Contact: Jane Schwebke, MD | 205-975-5665 | schwebke@uab.edu |
United States, Alabama | |
Jefferson County Department of Health STD Clinic | Recruiting |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Jane Schwebke, MD | University of Alabama at Birmingham |
Responsible Party: | University of Alabama at Birmingham ( Jane Schwebke , MD ) |
Study ID Numbers: | F040329003, R01AI058033 |
Study First Received: | June 7, 2006 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00334633 History of Changes |
Health Authority: | United States: Federal Government |
bacterial vaginosis tinidazole |
Genital Diseases, Female Bacterial Infections Metronidazole Vaginosis, Bacterial |
Vaginitis Vaginal Diseases Alkylating Agents Tinidazole |
Bacterial Infections Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Vaginitis Vaginal Diseases Pharmacologic Actions |
Genital Diseases, Female Antiparasitic Agents Vaginosis, Bacterial Therapeutic Uses Antitrichomonal Agents Alkylating Agents Tinidazole |