Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial
18 Years
N/A
Male
Prostate Cancer
Trial Information
Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial
The study will provide data on the tolerance, safety and acceptance of Depo-Eligard®
(leuproreline acetate) when used in routine clinical practice. Data on efficacy parameters
such as testosterone, PSA levels, symptoms and treatment failure, if available will be
collected.It will reflect the way Depo-Eligard® is used in routine clinical practice and how
PSA, testosterone levels, symptoms and treatment failure, are used as parameters in the
treatment for Prostate Cancer.
Patient data will be collected after a treatment period of six months.
Inclusion Criteria:
- Patients having been prescribed Depo-Eligard® in accordance with the terms of the
marketing authorization
- Patients on treatment with Depo-Eligard® for at least six months
- Written consent has been obtained
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®
Outcome Time Frame:
After at least 6 months treatment with Depo-Eligard
Safety Issue:
No
Principal Investigator
Use Central Contact
Investigator Role:
Study Director
Investigator Affiliation:
Astellas Pharma Europe BV
Authority:
Belgium: Institutional Review Board
Study ID:
BE-08-EGD-02
NCT ID:
NCT00811876
Start Date:
September 2008
Completion Date:
December 2009
Related Keywords:
- Prostate Cancer
- Prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|
