Prostate cancer patient MedDRA version: 7.0 Level: pr t Classification code 10060862
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Has completed the CS15 study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Has been withdrawn from the FE200486 CS15 study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of different dosing regimens;Primary end point(s): Changes in clinical safety parameters (adverse events including death from any cause, local tolerability, physical examination, vital signs, ECG and body weight) Clinically significant changes in laboratory safety parameters (biochemistry and haematology) ;Secondary Objective: To evaluate the proportion of patients with testosterone =0.5 ng/mL of different dosing regimens. To evaluate the proportion of patients with disease progression (PSA progression, death from any cause, introduction of additional therapy-related to the prostate cancer) of different dosing regimens. | — |
Countries
Belgium, Finland, Germany, Netherlands, United Kingdom
Outcome results
None listed