Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays

Stopped early

Conditions studied: Chlamydia Infections, Gonorrhea, Trichomonas Infections

In brief

The objective of this study is to obtain female first-catch urine, vaginal, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.

Key facts

Study ID

NCT01728103

Run by

Gen-Probe, Incorporated

People needed

1336

Starts

2013-01-01

Last updated by the study team

2017-08-16

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Infectious Diseases STD Program University of Alabama at Birmingham — Birmingham, Alabama, United States
• Medical Center for Clinical Research — San Diego, California, United States
• Healthcare Clinical Data — North Miami, Florida, United States
• Mount Vernon Clinical Research — Sandy Springs, Georgia, United States
• Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease — New Orleans, Louisiana, United States
• John Hopkins University — Baltimore, Maryland, 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
• Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology — Cincinnati, Ohio, United States
• Planned Parenthood Southeastern Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• The Jackson Clinic — Jackson, Tennessee, United States
• Planned Parenthood Gulf Coast — Houston, Texas, United States
• Tidewater Clinical Research — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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