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

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Oct 2017

At a glance

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

    • 20 Oct 2017 According to an Antares Pharma media release, the company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for XYOSTED (testosterone enanthate) injection. The CRL indicates that the FDA cannot approve the NDA in its present form because the FDA is concerned that XYOSTED could cause a clinically meaningful increase in blood pressure and raised a concern regarding the occurrence of depression and suicidality.
    • 08 Aug 2017 According to an Antares Pharma media release, data from this trial has been presented at a moderated poster session at the annual American Urological Association meeting 2017.
    • 16 May 2017 According to an Antares Pharma media release, data from the study will be presented at the American Urological Association Annual Meeting 2017.
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