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Clinical Evaluation of Visby Medical Men's Sexual Health Test

NCT07659808 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 507

Last updated 2026-08-14

No results posted yet for this study

Summary

This is a multi-center study in which the performance of the Visby Medical Men's Sexual Health Test is evaluated when run by male subjects of 14 years of age and older on self-collected first catch urine samples using the audio-visual instructions provided by the Visby App and/or written instructions provided by the printed User Instructions.

Conditions

  • Sexually Transmitted Diseases

Interventions

DIAGNOSTIC_TEST

Visby Medical Men's STI PCR Test Kit

The Visby Medical Men's STI PCR Test is a single use (disposable), automated PCR (Polymerase Chain Reaction) in vitro diagnostic self-test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. This test is intended to be sold over the counter (OTC) for use by males suspected of sexually transmitted infection with Chlamydia trachomatis and Neisseria gonorrhoeae.

Sponsors & Collaborators

  • Visby Medical

    lead INDUSTRY

Eligibility

Min Age
14 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-05
Primary Completion
2026-07-21
Completion
2026-07-21

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07659808 on ClinicalTrials.gov