Female Urine, Vaginal & Endocervical Swab & Cervical Specimen Collections for APTIMA Trichomonas Vaginalis Assay Testing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

532 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 the APTIMA Trichomonas vaginalis (ATV) Assay.

These specimens will be used to demonstrate assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01728103

Chlamydia Infections Gonorrhea Trichomonas Infections

TERMINATED

Prospective Collection of Female and Male Specimens for PANTHER® System Testing

NCT01638637

Chlamydia Infections Gonorrhea

COMPLETED

Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System

NCT01358799

Chlamydia Trachomatis

WITHDRAWN

Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System

NCT01733069

Chlamydia Trachomatis Neisseria Gonorrhoeae Infection

COMPLETED

Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs

NCT01316120

Human Papillomavirus Infection

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Trichomonas Vaginalis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

APTIMA Trichomonas vaginalis (ATV) Assay

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes