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Full eligibility criteria for NCT01728103
Ages eligible for Study
16 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
The subject is at least 16 years of age at the time of enrollment and is currently sexually active (has had penile/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 his/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:
The subject reports symptoms consistent with a suspected sexually transmissible infection (STI) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort
Subject is asymptomatic and known to be partners with, or a contact of, a person with a confirmed or suspected STI(s)
Subject is asymptomatic and undergoing screening evaluation for possible STIs
Subject is asymptomatic and undergoing a routine examination with a pelvic examination
The subject took antibiotic medications within the last 21 days
Subject already participated in this 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
All locations for NCT01728103
United States (14)
Infectious Diseases STD Program University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Medical Center for Clinical Research
San Diego, California, United States, 92108
Healthcare Clinical Data
North Miami, Florida, United States, 33161
Mount Vernon Clinical Research
Sandy Springs, Georgia, United States, 30328
Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
New Orleans, Louisiana, United States, 70112
John Hopkins University
Baltimore, Maryland, United States, 21205
New England Center for Clinical Research
Fall River, Massachusetts, United States, 02720
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7030
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, United States, 45229-3039
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
The Jackson Clinic
Jackson, Tennessee, United States, 38305
Planned Parenthood Gulf Coast
Houston, Texas, United States, 77023
Tidewater Clinical Research
Norfolk, Virginia, United States, 23502
View full eligibility
Tris trial is registered with FDA with number: NCT01728103. The sponsor of the trial is Gen-Probe, Incorporated and it is looking for 1336 volunteers for the current phase.
Official trial title: Prospective Collection of Female First-catch Urine, Vaginal Swab,Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays
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