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

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2018

At a glance

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

    • 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.
    • 27 Mar 2018 According to an Antares Pharma media release, official minutes from the Type A meeting with the U.S. FDA has been received. Based on the minutes, company expects to resubmit the re-analyses of existing data and expects to submit the complete response to FDA in the Q2 2018.
    • 16 Jan 2018 According to an Antares Pharma media release, type A meeting has been scheduled with the U.S. Food and Drug Administration (FDA) on February 21, 2018 for XYOSTED in response to the Complete Response Letter (CRL).
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