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
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
- 10 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.