Treatment of Bacterial Vaginosis (BV) With Tinidazole
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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 4 |
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 |
- Cure of Bacterial Vaginosis [ Time Frame: one month ] [ Designated as safety issue: No ]
- 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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
United States, Alabama | |
Jefferson County Department of Health STD Clinic | |
Birmingham, Alabama, United States, 35294 |
Principal Investigator: | Jane Schwebke, MD | University of Alabama at Birmingham |
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 October 16, 2012