An Open-Label, Multi-Centre, Extension Study, evaluating the Long-Term Safety and Tolerability of Different Three-Month Degarelix Dosing Regimens, 240 mg (40 mg/mL), 240 mg (60 mg/mL), in Patients with Prostate Cancer. -

Active, not recruiting

• Conditions: Prostate cancer patient; MedDRA version: 7.0Level: pr tClassification code 10060862

• Registration Number: EUCTR2005-004943-72-NL
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-20
• Last Update Posted: 2012-04-03

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 425

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

Has been withdrawn from the FE200486 CS15 study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of different dosing regimens;Secondary Objective: To evaluate the proportion of patients with testosterone =0.5 ng/mL of different dosing regimens. <br>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.<br>;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)<br>Clinically significant changes in laboratory safety parameters (biochemistry and haematology) <br>