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Extract
Part A: preliminary investigation of the safety, pharmacodynamics and pharmacokinetics of a new leuprolide acetate depot 3-month formulation after i.m. or s.c. administration to patients with prostate cancer. Part B: investigation of the safety, pharmacodynamics and pharmacokinetics of a new leuprolide 3-month formulation in patients with prostate cancer after administration of a single dose of 22.5 mg leuprolide acetate by i.m. or s.c. injection (according to the results of study part A, see § 3.2).
Inclusion criteria
- Prostate cancer