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Treatment of Bacterial Vaginosis With Oral Tinidazole

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00229216
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : March 22, 2017
Sponsor:
Information provided by:
Mission Pharmacal

Tracking Information
First Submitted Date  ICMJE September 27, 2005
First Posted Date  ICMJE September 29, 2005
Last Update Posted Date March 22, 2017
Study Start Date  ICMJE January 2005
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
  • Therapeutic efficacy
  • Safety
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00229216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2005)
  • Clinical efficacy
  • Microbiological efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Bacterial Vaginosis With Oral Tinidazole
Official Title  ICMJE A Phase III Randomized, Multi-center, Double-blind, Double-dummy, Placebo-controlled Treatment Trial of Bacterial Vaginosis With Tinidazole Oral Tablets.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE Drug: Tinidazole
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2005)
200
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Clinical and microbiological diagnosis of bacterial vaginosis -

Exclusion Criteria:

Other sexually transmitted disease

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00229216
Other Study ID Numbers  ICMJE T-500
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Mission Pharmacal
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mission Pharmacal
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP