A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Trial Profile

A Phase 3, Randomized, Active-controlled, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU) in Hypogonadal Men

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Jun 2017

At a glance

  • Drugs Testosterone undecanoate (Primary)
  • Indications Hypogonadism
  • Focus Therapeutic Use
  • Acronyms inTUne
  • Sponsors Clarus Therapeutics
  • Most Recent Events

    • 26 Jun 2017 According to an Clarus Therapeutics media release, based on the data from this trial the company has re-submitted the New Drug Application (NDA) for JATENZO for the treatment of low testosterone in hypogonadal men, to the U.S. Food and Drug Administration (FDA). The new submission addresses all points raised by the FDA in the Complete Response Letter (CRL) issued to Clarus.
    • 26 Jun 2017 Results published in a Clarus Therapeutics media release.
    • 30 Jan 2017 Status changed from active, no longer recruiting to completed.
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