Treatment of Bacterial Vaginosis (BV) With Tinidazole
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ClinicalTrials.gov Identifier: NCT00334633 |
Recruitment Status :
Completed
First Posted : June 8, 2006
Results First Posted : June 23, 2011
Last Update Posted : December 2, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bacterial Vaginosis | Drug: tinidazole, metronidazole | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 593 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Tinidazole for the Treatment of Bacterial Vaginosis |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
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 |
- Cure of Bacterial Vaginosis [ Time Frame: one month ]resolution of Amsel criteria for bacterial vaginosis
- Recurrence of BV [ Time Frame: baseline to 4 weeks ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334633
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 |
Responsible Party: | Jane Schwebke, Principal Investigator, University of Alabama at Birmingham |
ClinicalTrials.gov Identifier: | NCT00334633 |
Other Study ID Numbers: |
F040329003 R01AI058033 ( U.S. NIH Grant/Contract ) |
First Posted: | June 8, 2006 Key Record Dates |
Results First Posted: | June 23, 2011 |
Last Update Posted: | December 2, 2017 |
Last Verified: | October 2017 |
bacterial vaginosis tinidazole |
Vaginosis, Bacterial Vaginal Diseases Bacterial Infections Vaginitis Metronidazole Tinidazole Anti-Infective Agents |
Anti-Bacterial Agents Antiprotozoal Agents Antiparasitic Agents Alkylating Agents Molecular Mechanisms of Pharmacological Action Antitrichomonal Agents |