A 6-Month Safety Study of QuickShot Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Trial Profile

A 6-Month Safety Study of QuickShot Testosterone Administered Subcutaneously Once Each Week to Adult Males With Hypogonadism

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

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

    • 27 Feb 2017 According to an Antares Pharma media release, New Drug Application (NDA) for QuickShot Testosterone (QST), been accepted for standard review by the U.S Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of October 20, 2017.
    • 16 Aug 2016 Status changed from active, no longer recruiting to completed.
    • 09 Aug 2016 According to an Antares Pharma media release, company plans to submit the NDA to the FDA by the end of the fourth quarter of 2016.
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