An Open-Label, Multi-Centre, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One-Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation Therapy
Phase 1
- Conditions
- Patients with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.MedDRA version: 14.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2006-006913-34-GB
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 568
Inclusion Criteria
1.Has given written informed consent before 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
2.Has completed the one-year main study, FE 200486 CS21
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1.Has been withdrawn/discontinued from the FE 200486 CS21 study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 dosing regimen in prostate cancer patients;<br> Secondary Objective: •To evaluate testosterone response during long-term treatment with degarelix one-month dosing regimen<br> •To evaluate PSA response during long-term treatment with degarelix one-month dosing regimen<br> •To evaluate testosterone, PSA, LH, and FSH responses from the time of switch from LUPRON DEPOT® to degarelix<br> ;<br> Primary end point(s): •Changes in clinical safety parameters (adverse events including death from any cause, physical examination, vital signs, ECGs, and body weight)<br> •Clinically significant changes in laboratory safety parameters (clinical chemistry, haematology, and urinalysis)<br>
- Secondary Outcome Measures
Name Time Method