Treatment of Bacterial Vaginosis (BV) With Tinidazole

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

Detailed Description
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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.

Official Title
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Tinidazole for the Treatment of Bacterial Vaginosis

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Drug: tinidazole, metronidazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>metronidazole 500 BID for 7 days | Drug: tinidazole, metronidazole<br>* Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid<br>* Other names: Tindamax, Flagyl;|
| Active Comparator: tinidazole 500<br>tinidazole 500 BID for 7 days | Drug: tinidazole, metronidazole<br>* Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid<br>* Other names: Tindamax, Flagyl;|
| Active Comparator: tinidazole 1 gm<br>tinidazole 1 gm BID for 7 days | Drug: tinidazole, metronidazole<br>* Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid<br>* Other names: Tindamax, Flagyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure of Bacterial Vaginosis | resolution of Amsel criteria for bacterial vaginosis | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of BV |  | baseline to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial vaginosis, tinidazole