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A Multicenter, Open, Non-Comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-Month Formulation in Patients With Advanced Prostate Cancer

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Trial Profile

A Multicenter, Open, Non-Comparative, Phase III Study on the Efficacy, Pharmacokinetics and Safety of Two Injections of Triptorelin Embonate 22.5 mg 6-Month Formulation in Patients With Advanced Prostate Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Triptorelin (Primary)
  • Indications Prostate cancer
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Debiopharm

    • Most Recent Events

    • 11 Mar 2010 The US FDA has approved the 6-month triptorelin formulation, according to a Watson pharmaceuticals media release. The approval is based on results from this trial.
    • 13 Oct 2009 Ipsen and Debiopharm announced that the 6-month triptorelin formulation has sucessfully completed the European decentralised registration procedure involving 9 European countries.
    • 25 Sep 2008 Debiopharm Group filing an MAA with the EMEA based on data from this trial, according to Debiopharm media release.

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