Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Bacterial Vaginosis With Oral Tinidazole

This study has been completed.
Information provided by:
Mission Pharmacal Identifier:
First received: September 27, 2005
Last updated: June 18, 2007
Last verified: June 2007

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:

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.


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

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 identifier: NCT00229216

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 Identifier (NCT Number): 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
Genital Diseases, Female
Vaginal Diseases
Alkylating Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Antitrichomonal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on February 25, 2015