Treatment of BV With Tinidazole
Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Vaginosis
Intervention: tinidazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s):
Jane Schwebke, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Overall contact:
Joy Lewis, Phone: 205-996-2780
Summary
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better
than treatment with metronidazole
Clinical Details
Official title: Tinidazole for the Treatment of Bacterial Vaginosis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
Primary outcome: cure of BV
Secondary outcome: recurrence of BV
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:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Joy Lewis, Phone: 205-996-2780
Jefferson County Department of Health STD Clinic, Birmingham, Alabama 35294, United States; Recruiting
Additional Information
Starting date: November 2004
Ending date: December 2009
Last updated: August 17, 2009
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