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Completed

NCT Number: NCT00229216

Treatment of Bacterial Vaginosis With Oral Tinidazole

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

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duke University School of Medicine

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical and microbiological diagnosis of bacterial vaginosis -

Exclusion criteria

Other sexually transmitted disease

-

Treatment and study plan

Tinidazole

Drug

Primary outcomes

  1. Therapeutic efficacy

  2. Safety

Secondary outcomes

  1. Clinical efficacy

  2. Microbiological efficacy

Sponsors and collaborators

Lead sponsor

Mission Pharmacal

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 29, 2005
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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