A Phase 3, Multi-center, Randomized, Open-label, Parallel-group, Comparative Study of TAP-144-SR (3M) to Evaluate Hormone Dynamics, Pharmacokinetics, Safety and Efficacy of TAP-144-SR (6M) 22.5 mg Subcutaneous Injection for 48 Weeks in Prostate Cancer Patients Previously Treated With Hormonal Therapy

Trial Profile

A Phase 3, Multi-center, Randomized, Open-label, Parallel-group, Comparative Study of TAP-144-SR (3M) to Evaluate Hormone Dynamics, Pharmacokinetics, Safety and Efficacy of TAP-144-SR (6M) 22.5 mg Subcutaneous Injection for 48 Weeks in Prostate Cancer Patients Previously Treated With Hormonal Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 23 May 2016

At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 28 Sep 2015 According to a media release, Takeda has obtained a New Drug Application approval of Leuplin PRO for injection kit 22.5 mg, based on the results from this and another phase II trial.
    • 14 Oct 2014 Status changed from recruiting to completed according ClinicalTrials.gov record.
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