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Treatment of Bacterial Vaginosis With Oral Tinidazole

This study has been completed.
Sponsor:
Information provided by:
Mission Pharmacal
ClinicalTrials.gov Identifier:
NCT00229216
First received: September 27, 2005
Last updated: June 18, 2007
Last verified: June 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Bacterial Vaginosis
 Drug: Tinidazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Multi-Center, Double-Blind, Double-Dummy, Placebo-Controlled Treatment Trial of Bacterial Vaginosis With Tinidazole Oral Tablets.

Resource links provided by NLM:

Drug Information available for: Tinidazole
U.S. FDA Resources

Further study details as provided by Mission Pharmacal:

Primary Outcome Measures:
  • Therapeutic efficacy
  • Safety

Secondary Outcome Measures:
  • Clinical efficacy
  • Microbiological efficacy

Estimated Enrollment: 200
Study Start Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Clinical and microbiological diagnosis of bacterial vaginosis -

Exclusion Criteria:

Other sexually transmitted disease

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00229216

Locations
United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Mission Pharmacal
  More Information

No publications provided by Mission Pharmacal

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00229216     History of Changes
Other Study ID Numbers: T-500
Study First Received: September 27, 2005
Last Updated: June 18, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female
Tinidazole
Alkylating Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antitrichomonal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013