Comparative Performance of a Vaginal Yeast Test

Recruiting Observational Study
Vulvovaginal Candidiasis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
1,200 (estimated)
Sponsor
Uniformed Services University of the Health Sciences · Federal
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About This Trial
The purpose of this study is to establish lay user performance criteria for the SavvyCheck Vaginal Yeast Test in comparison to standard vaginal yeast culture and identification method for Candida (the Reference Method). Polymerase chain reaction (PCR) and sequencing of fungi will be used as an aid to explain the nature of the discrepancy in the case of discordant results between the lay user-perfo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Symptomatic Women Symptomatic women include those women who present with a complaint consistent with symptoms of vaginitis (e.g., increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urinatio…
Contacts

Elizabeth A Kostas-Polston, PhD

301.295.1531

elizabeth.kostas-polston@usuhs.edu

CONTACT

Mary B Engler, PhD

301.295.3427

mary.engler@usuhs.edu

CONTACT