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. -
- Conditions
- Prostate cancer patientMedDRA 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
Recruitment & Eligibility
- Status
- ot 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Has been withdrawn from the FE200486 CS15 study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>
- Secondary Outcome Measures
Name Time Method