Prospective Collection of Female First-catch Urine, Vaginal Swab, Endocervical Swab, and Cervical Specimens for Testing With the APTIMA Trichomonas Vaginalis Assay

Gen-Probe, Incorporated7 sites in 1 country532 target enrollmentAugust 2012

ConditionsTrichomonas Vaginalis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Trichomonas Vaginalis
Sponsor: Gen-Probe, Incorporated
Enrollment: 532
Locations: 7
Primary Endpoint: Negative Percent Agreement Using the TIGRIS Instrument as a Reference.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

December 2013

Last Updated

12 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Gen-Probe, Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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