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A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Trial Profile

A Multiple-dose, 52-week Study to Evaluate the Efficacy and Safety of Testosterone Enanthate Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2018

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At a glance

  • Drugs Testosterone enanthate (Primary)
  • Indications Hypogonadism
  • Focus Registrational; Therapeutic Use
  • Acronyms STEADY
  • Sponsors Antares Pharma
  • Most Recent Events

    • 05 Oct 2018 Results published in the Journal of Urology
    • 01 Oct 2018 According to an Antares Pharma media release, XYOSTED injection (once-weekly, at-home self-administration with an easy-to-use, single dose, disposable QuickShot auto injector) has been approved by the U.S. Food and Drug Administration for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
    • 31 Aug 2018 Biomarkers information updated
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