Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing

Completed

Conditions studied: Trichomonas Vaginalis

In brief

The objective of this study is to obtain female first-catch urine, vaginal swab, endocervical swab, and cervical specimens collected in PreservCyt Solution ("PreservCyt Specimens") for testing with the APTIMA Trichomonas vaginalis (ATV) Assay. These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Key facts

Study ID: NCT01427023
Run by: Gen-Probe, Incorporated
People needed: 532
Starts: 2012-08-01
Expected to finish: 2013-12-01
Last updated by the study team: 2014-02-06

Who can join

Age: 14 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Subject must be female and attend a participating clinic
Subject must be at least 14 years of age at the time of enrollment and is currently sexually active (has had vaginal intercourse within the past 12 months)
The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of her parent or legal guardian, unless the site has an institutional review board (IRB)- approved waiver for parental consent for minors)
In addition, the subject must meet at least one of the following criteria:
Subject must demonstrate symptoms consistent with a suspected STD such as vaginal odor, vaginal discharge, vaginal/vulvar itching or irritation, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
Subject must be asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STD(s)
Subject must be asymptomatic and undergoing screening evaluation for possible STDs
Subject must be undergoing Pap screening

You may not qualify if…

Subject took antibiotic medications within the last 14 days
Subject already participated in the study
Subject has a history of illness that the principal investigator (PI) or designee considers could interfere with or affect the conduct, results, and/or completion of the clinical trial
Subject has a history of illness that the PI or designee considers could create an unacceptable risk to the subject if enrolled

Where it is running

University of Alabama, Birmingham — Birmingham, Alabama, United States
Wishard Hospital - Indiana University School of Medicine — Indianapolis, Indiana, United States
Louisiana State University — New Orleans, Louisiana, United States
New England Center for Clinical Research — Fall River, Massachusetts, United States
University of North Carolina, Chapel Hill — Chapel Hill, North Carolina, United States
Geneuity Clinical Research Services — Maryville, Tennessee, United States
Planned Parenthood Gulf Coast — Houston, Texas, United States

Full record on ClinicalTrials.gov

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