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A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days

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Trial Profile

A 90-Day, Randomized, Dose-Ranging Study, Including Potential Dose Titration, Evaluating the Efficacy and Safety of Intranasal TBS-1 in the Treatment of Male Hypogonadism With Sequential Safety Extension Periods of 90 and 180 Days

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Testosterone (Primary)
  • Indications Hypogonadism
  • Focus Registrational; Therapeutic Use
  • Sponsors Acerus Pharmaceuticals

    • Most Recent Events

    • 08 Jul 2019 Results presented in a Acerus Pharmceuticals Media Release.
    • 08 Jul 2019 According to an an Acerus Pharmceuticals media release, post-hoc analysis data from this study were published in the Journal of the Endocrine Society.
    • 20 Mar 2018 Results (n=306) assessing efficacy of different doses (22mg versus 33mg) of bioadhesive intranasal testosterone gel in men with hypogonadism, were presented at The 100th Annual Meeting of the Endocrine Society.
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