Comparing NAAT Testing to Standard Methods for the Diagnosis of Vaginitis

Completed

Conditions studied: Bacterial Vaginosis, Vulvovaginal Candidiasis, Trichomoniasis

In brief

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). Establishing the correct etiology of symptomatic vaginitis can be challenging, and the evaluation of vaginitis by physicians is often substandard. The investigators will determine whether NAAT testing will improve the diagnosis of vaginal infections including bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).

Key facts

Study ID

NCT02203942

Run by

University of Pittsburgh

People needed

300

Starts

2014-07-01

Expected to finish

2015-06-01

Last updated by the study team

2016-01-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Use of oral antibiotics in the past 14 days
• Use of vaginal products or lubricant, vaginal intercourse, or douching in the last 24 hour

Where it is running

• Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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