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

Gen-Probe, Incorporated14 sites in 1 country1,336 target enrollmentJanuary 2013

ConditionsChlamydia Infections Gonorrhea Trichomonas Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chlamydia Infections
Sponsor: Gen-Probe, Incorporated
Enrollment: 1336
Locations: 14
Primary Endpoint: Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease
Status: Terminated
Last Updated: 8 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, cervical and endocervical swabs for testing with multiple APTIMA Assays on the Gen-Probe PANTHER® and TIGRIS® Systems.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

July 2014

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Gen-Probe, Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Qualitative detection of ribosomal RNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) to aid in the diagnosis of chlamydial and/or gonococcal and/or trichomonal urogenital disease

Time Frame: approximately one year