Treatment of Bacterial Vaginosis With Oral Tinidazole

A Phase III Randomized, Multi-center, Double-blind, Double-dummy, Placebo-controlled Treatment Trial of Bacterial Vaginosis With Tinidazole Oral Tablets.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00229216

Enrollment

200

Registered

2005-09-29

Start date

2005-01-31

Completion date

2007-06-30

Last updated

2017-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis

Brief summary

The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.

Detailed description

Tinidazole is a second-generation nitroimidazole i.e. an updated form of the standard drug used to treat bacterial vaginosis (metronidazole). Two dosing regimens are being compared to placebo to treat bacterial vaginosis, one of the most common vaginal infections.

Interventions

DRUGTinidazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Clinical and microbiological diagnosis of bacterial vaginosis -

Exclusion criteria

Other sexually transmitted disease \-

Design outcomes

Primary

Measure	Time frame
Therapeutic efficacy	—
Safety	—

Secondary

Measure	Time frame
Clinical efficacy	—
Microbiological efficacy	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026