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Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study

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Trial Profile

Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy ResponSE in Hypogonadal Men (TRAVERSE) Study

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 16 May 2025

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At a glance

  • Drugs Testosterone (Primary)
  • Indications Hypogonadism
  • Focus Adverse reactions
  • Acronyms TRAVERSE
  • Sponsors AbbVie

Most Recent Events

  • 12 Mar 2025 According to Lipocine media release, company announced that the U.S. Food and Drug Administration (FDA) has recently informed sponsors of approved testosterone products about class-wide labeling changes. This decision follows the Agency review of the findings from the TRAVERSE trial.
  • 03 Mar 2025 According to a Marius Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has implemented significant labeling changes for KYZATREX (testosterone undecanoate) CIII capsules. This decision follows the conclusion of the TRAVERSE trial and comprehensive blood pressure monitoring studies, marking a pivotal advancement in testosterone replacement therapy (TRT).
  • 18 Jan 2024 Results of a sub-trial assessing cardiovascular safety of testosterone treatment in middle-aged and older men with hypogonadism in a time-to-event analysis published in the New England Journal of Medicine

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