NCT00682851|CompletedResults
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Sponsor study identifier
observational
519
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Actual (reported)Study Completion
April 2009
Actual (reported)This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 16, 2008
Actual (reported)May 22, 2008
Actual (reported)July 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 2009
Actual (reported)April 2009
Actual (reported)August 8, 2011
Actual (reported)Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.
Visit 1
Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women
Visit 1
Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.
Visit 1
Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.
Visit 1
Rapid test run using vaginal discharge collected via a cotton swab
Rapid test run using vaginal discharge collected using a cotton swab
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Non-pregnant women between the ages of 18 and 60, with or without symptoms of vaginitis, were recruited for this study from Magee-Womens Hospital of University of Pittsburgh Medical Center and Allegheny County Health Department.
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
A major limitation of this study was that in the first 122 women, 24% of the cohort, the vaginal swabs used for the diagnostic tests were collected in random order, which resulted in decreased sensitivity of the OSOM Rapid and BVBLue tests.
Sharon L Hillier, PhD
University of Pittsburgh
519 participants (actual enrollment reported by the registry).
First Submitted
May 16, 2008
First Posted
May 22, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis
Contact the study team to confirm eligibility.
Primary Completion
April 2009
Actual (reported)Study Completion
April 2009
Actual (reported)Last Updated
September 22, 2016
Results First Posted
August 8, 2011
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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