Treatment of Bacterial Vaginosis (BV) With Tinidazole

Bacterial Vaginosis Clinical Trial

Official title:

Tinidazole for the Treatment of Bacterial Vaginosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334633
• Other study ID #: F040329003
• Secondary ID: R01AI058033
• Status: Completed
• Phase: Phase 4
• First received: June 7, 2006
• Last updated: October 26, 2017
• Start date: November 2004
• Est. completion date: December 2009

Study information

• Verified date: October 2017
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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:

1. 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

2. To compare the side effect profiles of tinidazole versus metronidazole in the treatment of BV

3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Drug:
• tinidazole, metronidazole
Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid

Locations

Country	Name	City	State
United States	Jefferson County Department of Health STD Clinic	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure of Bacterial Vaginosis	resolution of Amsel criteria for bacterial vaginosis	one month
Secondary	Recurrence of BV		baseline to 4 weeks