Treatment of Bacterial Vaginosis (BV) With Tinidazole

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.

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