Status:
COMPLETED
Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing
Lead Sponsor:
Gen-Probe, Incorporated
Conditions:
Trichomonas Vaginalis
Eligibility:
FEMALE
14+ years
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
532 Patients enrolled
Trial Details
Trial ID
NCT01427023
Start Date
August 1 2012
End Date
December 1 2013
Last Update
February 6 2014
Active Locations (7)
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1
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
2
Wishard Hospital - Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
3
Louisiana State University
New Orleans, Louisiana, United States, 70112
4
New England Center for Clinical Research
Fall River, Massachusetts, United States, 02720