Conditions: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 109
Healthy volunteers: no

Brief summary:
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\] for serum testosterone in patients with advanced prostate cancer.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Intervention descriptions: intervention 1: Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85.

Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.

Protocol document: