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A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)

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Trial Profile

A 12-Month, Randomized, Active-controlled, Open-label Study of the Efficacy and Safety of Oral Testosterone Undecanoate in Hypogonadal Men (RE-TUne)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2024

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At a glance

  • Drugs Testosterone undecanoate (Primary) ; Testosterone
  • Indications Hypogonadism
  • Focus Registrational; Therapeutic Use
  • Acronyms RE-TUne
  • Sponsors Marius Pharmaceuticals; SOV Therapeutics

Most Recent Events

  • 30 Jul 2024 According to a Marius Pharmaceuticals media release, the company announce the submission of its New Drug Submission (NDS) for KYZATREX (testosterone undecanoate) CIII capsules to Health Canada for approval with an anticipated approval date in Q2 of 2025.
  • 23 Mar 2021 Results presented at the 103rd Annual Meeting of the Endocrine Society.
  • 05 Jan 2021 According to a Marius Pharmaceuticals media release, results will be published in leading medical journals and presented at national conferences during 2021.

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