Status:
COMPLETED
Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis
Lead Sponsor:
University of Pittsburgh
Conditions:
Bacterial Vaginosis
Vulvovaginal Candidiasis
Eligibility:
FEMALE
18+ years
Brief Summary
Vaginitis is the most common condition encountered in the gynecologist's office and is most commonly caused by bacerial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV). E...
Detailed Description
Several commercial nucleic acid amplification tests (NAAT) are available to identify causative organisms. One of these commercial tests has undergone validation published in a scientific journal, only...
Eligibility Criteria
Inclusion
- Female participants aged 18 and older
- Based on symptoms:
- Symptomatic patients: with symptoms of vaginitis that include abnormal discharge, malodor, itching, irritation and / or discomfort
- Asymptomatic controls: no vulvovaginal symptoms
- Willing to provide written informed consent for participation in this study
Exclusion
- Use of oral antibiotics in the past 14 days
- Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24 hour
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02203942
Start Date
July 1 2014
End Date
June 1 2015
Last Update
January 27 2016
Active Locations (1)
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1
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213