Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a home urine test revolutionize STI screening for men?

NCT ID NCT07659808

Diagnosis Sponsor: Visby Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study evaluates a disposable, at-home PCR test that detects chlamydia and gonorrhea from a urine sample. Men aged 14 and older collect their own sample and use the test with app or written instructions. The goal is to see if the test works accurately outside a clinic, potentially making STI screening easier and more private.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Visby Medical Men's STI PCR Test Kit
What this could lead to
If accurate, this could make STI testing more private and convenient, helping more men get tested and treated sooner.
What could go wrong
The test is still being evaluated; it may not be as accurate as lab tests, and user error could affect results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

507 people

The number who actually took part.

Started

Feb 2026

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will consist of subjects with a penis ≥14 years of age who are symptomatic or asymptomatic for sexual transmitted infections (STIs). Subjects will be classified as symptomatic if they report unusual urethral discharge, painful urination, testicular or scrotal pain/swelling, increased urinary frequency, pain or bleeding during sex/intercourse within 7 days prior to enrollment. To better represent the end users of this product, subjects not actively seeking health care will be recruited into the study with the goal that \~30% of subjects would fall in this category.

Ages

14 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Willing and able to provide written informed consent and/or assent as required by the reviewing IRB or IEC. Experimental Bill of Rights will also be documented for all study subjects enrolled in applicable states. * ≥14 years of age at the time of enrollment. * Subject has a penis at the time of enrollment. * Able to read and understand instructions provided for the study. * Willing and able to follow all study procedures, including performing self-collection of one urine sample, running the sample on a Visby test, and using the Visby App to interpret the test results. Exclusion Criteria: * Have a medical condition, serious illness, or other circumstance that, in the investigator's judgment, could jeopardize the subject's safety, or could interfere with study procedures. * Have consumed oral or intramuscular or intravenous antibiotics, within 48 hours prior to enrollment. * The subject has urinated within the last one (1) hour prior to urine sample collection. * Have an in-dwelling catheter or practices intermittent catheterization for urinary drainage. * Have been previously enrolled in this study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Sexually transmitted diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

sexually transmitted disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sexually transmitted diseases

Contacts and locations

Locations

  • AHF Wellness Center - Broward

    Fort Lauderdale, Florida, 33316, United States

  • AHF Wellness Center - Peachtree

    Atlanta, Georgia, 30309, United States

  • CrescentCare Sexual Health Center

    New Orleans, Louisiana, 70119, United States

  • Healthcare Clinical Data Inc.

    Miami Lakes, Florida, 33016, United States

  • University of Washington, Virology Research Clinic

    Seattle, Washington, 98104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.