An open-label, multi-centre, extension study evaluation the long-term safety and tolerability of Degarelix one-month depots in patients with prostate cancer

Conditions: Prostate Cancer
MedDRA version: 7.0Level: pr tClassification code 10060862

Registration Number: EUCTR2004-003814-40-DE

Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

•Has given written consent prior to any study-related activity is performed. A study-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
•Has completed the FE200486 CS12 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Has been withdrawn from the FE200486 CS12 study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 safety and tolerability during long-term treatment with degarelix one-month depots in prostate cancer patients.;Secondary Objective: •To evaluate the testosterone response during long-term treatment with degarelix one-month depots in prostate cancer patients. <br>•To evaluate the PSA response during long-term treatment with degarelix one-month depots in prostate cancer patients. <br>•To evaluate the time to disease progression (PSA progression, death from any cause, introduction of additional therapy related to the prostate cancer) during long-term treatment with degarelix one-month depots in prostate cancer patients. <br>;Primary end point(s): •Changes in clinical safety parameters (AEs, local tolerability, physical examination, vital signs, ECG and body weight).<br>•Clinically significant changes in laboratory safety parameters (biochemistry, haematology and urialysis).<br>

Secondary Outcome Measures