Phase 4
N=593
Treatment of Bacterial Vaginosis (BV) With Tinidazole
Bacterial Vaginosis
Bottom Line
View on ClinicalTrials.gov: NCT00334633 ↗Enrolled (actual)
593
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Cure of Bacterial Vaginosis — 75; 73; 77 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- tinidazole, metronidazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure of Bacterial Vaginosis |
75; 73; 77 | — |
| SECONDARY Recurrence of BV |
42; 45; 37 | — |
Summary
We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than treatment with metronidazole
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00334633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.