Clinical Trials Directory

Trials / Completed

CompletedNCT01234350

A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist

Status
Completed
Phase
Study type
Observational
Enrollment
1,493 (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

Conditions

Timeline

Start date
2011-01-01
Primary completion
2018-03-27
Completion
2018-03-27
First posted
2010-11-04
Last updated
2019-06-25
Results posted
2019-05-20

Locations

160 sites across 15 countries: Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Slovakia, Switzerland, United Kingdom

Source: ClinicalTrials.gov record NCT01234350. Inclusion in this directory is not an endorsement.