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A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Trial Profile

A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Testosterone undecanoate (Primary) ; Testosterone
  • Indications Hypogonadism
  • Focus Registrational; Therapeutic Use
  • Acronyms inTUne
  • Sponsors Clarus Therapeutics
  • Most Recent Events

    • 20 Mar 2021 According to a Clarus Therapeutics media release, data from this study were presented virtually at ENDO 2021, the Endocrine Societys annual meeting (2021).
    • 20 Mar 2021 Results presented in a Clarus Therapeutics media release.
    • 08 May 2020 Results evaluating efficacy, short term safety, and alignment of new oral TU formulation with current standards for T replacement therapy, published in the Journal of Clinical Endocrinology and Metabolism

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