A Phase 3b, Non-randomized, Open-label, Multi-Centre, Follow-on Safety Trial of Monthly Doses of Degarelix in Patients with Prostate Cancer - FE200486 CS34
- Conditions
- Prostate CancerMedDRA version: 9.1Level: PTClassification code 10060862
- Registration Number
- EUCTR2008-006827-29-IT
- Lead Sponsor
- FERRING SPA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 345
Inclusion Criteria
1. Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient.
2. Has completed one of the following degarelix studies:
? FE 200486 CS27
? FE 200486 CS28
? FE 200486 CS30
? FE 200486 CS31
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
1. Has been withdrawn/discontinued from the original study in which they were participating.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the long-term safety of the dose regimen of degarelix proposed for marketing in patients with prostate cancer.;Secondary Objective: Investigate if there are changes in serum levels of PSA and Testosterone after treatment with degarelix 1-month dosing regimen in prostate cancer.;Primary end point(s): . Changes in clinical safety parameters (AEs, physical examinations, vital signs, and ECGs) <br>. Clinically significant changes in safety laboratory parameters (clinical chemistry, haematology, and urinalysis)
- Secondary Outcome Measures
Name Time Method