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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

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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: 06 Nov 2021

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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.
  • 05 Apr 2018 According to an Antares Pharma media release, U.S. Food and Drug Administration acknowledged receipt of the company's March 29, 2018 resubmission to the Complete Response Letter in connection with the XYOSTED New Drug Application and considered it as complete. User fee goal date assigned as September 29, 2018.

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