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
Price :
$35
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At a glance
- Drugs Triptorelin (Primary)
- Indications Prostate cancer
- Focus Pharmacokinetics; Registrational; Therapeutic Use
- Sponsors Debiopharm
- 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.