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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: March 21, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


Further study details as provided by Mission Pharmacal:

Primary Outcome Measures:
  • Therapeutic efficacy
  • Safety

Secondary Outcome Measures:
  • Clinical efficacy
  • Microbiological efficacy

Enrollment: 200
Study Start Date: January 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: March 21, 2017

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

ClinicalTrials.gov processed this record on September 21, 2017