Study Stopped
Corporate decision to spend money on other development programs.
Prospective Collection of Female Specimens for Testing With Gen-Probe APTIMA (Registered Trademark) Assays
4 other identifiers
observational
1,336
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 16, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedAugust 16, 2017
August 1, 2017
1.5 years
November 12, 2012
August 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
approximately one year
Study Arms (1)
No Treatment
Interventions
Eligibility Criteria
Female subjects at least 16 years of age, with or without symptoms of sexually transmitted disease.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Infectious Diseases STD Program University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Medical Center for Clinical Research
San Diego, California, 92108, United States
Healthcare Clinical Data
North Miami, Florida, 33161, United States
Mount Vernon Clinical Research
Sandy Springs, Georgia, 30328, United States
Louisiana State University Health Sciences Center Dept. of Medicine, Infectious Disease
New Orleans, Louisiana, 70112, United States
John Hopkins University
Baltimore, Maryland, 21205, United States
New England Center for Clinical Research
Fall River, Massachusetts, 02720, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599-7030, United States
Cincinnati Children's Hospital Medical Center Division of Pediatric & Adolescent Gynecology
Cincinnati, Ohio, 45229-3039, United States
Planned Parenthood Southeastern Pennsylvania
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The Jackson Clinic
Jackson, Tennessee, 38305, United States
Planned Parenthood Gulf Coast
Houston, Texas, 77023, United States
Tidewater Clinical Research
Norfolk, Virginia, 23502, United States
Biospecimen
urine; endocervical and vaginal swabs
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Renee Wait
Gen-Probe, Incorporated
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 16, 2012
Study Start
January 1, 2013
Primary Completion
July 1, 2014
Last Updated
August 16, 2017
Record last verified: 2017-08