Back to resultsTreatment of Bacterial Vaginosis With Oral Tinidazole
Primary Purpose
Bacterial Vaginosis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tinidazole
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis
Eligibility Criteria
Inclusion Criteria: Clinical and microbiological diagnosis of bacterial vaginosis - Exclusion Criteria: Other sexually transmitted disease -
Sites / Locations
- Duke University School of Medicine
Outcomes
Primary Outcome Measures
Therapeutic efficacy
Safety
Secondary Outcome Measures
Clinical efficacy
Microbiological efficacy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00229216
Brief Title
Treatment of Bacterial Vaginosis With Oral Tinidazole
Official Title
A Phase III Randomized, Multi-center, Double-blind, Double-dummy, Placebo-controlled Treatment Trial of Bacterial Vaginosis With Tinidazole Oral Tablets.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mission Pharmacal
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tinidazole
Primary Outcome Measure Information:
Title
Therapeutic efficacy
Title
Safety
Secondary Outcome Measure Information:
Title
Clinical efficacy
Title
Microbiological efficacy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical and microbiological diagnosis of bacterial vaginosis -
Exclusion Criteria:
Other sexually transmitted disease
-
Facility Information:
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17666604
Citation
Livengood CH 3rd, Ferris DG, Wiesenfeld HC, Hillier SL, Soper DE, Nyirjesy P, Marrazzo J, Chatwani A, Fine P, Sobel J, Taylor SN, Wood L, Kanalas JJ. Effectiveness of two tinidazole regimens in treatment of bacterial vaginosis: a randomized controlled trial. Obstet Gynecol. 2007 Aug;110(2 Pt 1):302-9. doi: 10.1097/01.AOG.0000275282.60506.3d.
Results Reference
derived
Learn more about this trial
Treatment of Bacterial Vaginosis With Oral Tinidazole
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