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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jul 2013

At a glance

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

    • 07 Jun 2017 Biomarkers information updated
    • 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.
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