Retrospective, Non-interventional Study of Depo-Eligard®.
OCT
Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial
1 other identifier
observational
140
1 country
23
Brief Summary
Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2008
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 22, 2010
January 1, 2010
1.2 years
December 17, 2008
January 21, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®
After at least 6 months treatment with Depo-Eligard
Secondary Outcomes (3)
Measurement of PSA and testosterone levels if available
After at least 6 months treatment with Depo-Eligard
Overall evaluation of efficacy
After a least 6 months treatment with Depo-Eligard
Overall patient assessment of treatment benefit
After at least 6 months treatment with Depo-Eligard
Interventions
Retrospective, Non-interventional
Eligibility Criteria
Patients from Belgian participating investigator sites having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization, on treatment with Depo-Eligard® for at least six months.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Antwerp, 2060, Belgium
Unknown Facility
Berlaar, 2590, Belgium
Unknown Facility
Bornem, 2880, Belgium
Unknown Facility
Brussels, 1020, Belgium
Unknown Facility
Brussels, 1070, Belgium
Unknown Facility
Brussels, 1090, Belgium
Unknown Facility
Charleroi, 6000, Belgium
Unknown Facility
Ghent, 9000, Belgium
Unknown Facility
Jemeppe, 4101, Belgium
Unknown Facility
Kortrijk, 8500, Belgium
Unknown Facility
Leuven, 3000, Belgium
Unknown Facility
Liège, 4000, Belgium
Unknown Facility
Lommel, 3290, Belgium
Unknown Facility
Merksem, 2170, Belgium
Unknown Facility
Mons, 7000, Belgium
Unknown Facility
Mortsel, 2640, Belgium
Unknown Facility
Ragnies, 6532, Belgium
Unknown Facility
Tienen, 3300, Belgium
Unknown Facility
Tongeren, 3700, Belgium
Unknown Facility
Turnhout, 2300, Belgium
Unknown Facility
Waregem, 8790, Belgium
Unknown Facility
Willebroek, 2830, Belgium
Unknown Facility
Yvoir, 5530, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma Europe B.V.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 19, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
January 22, 2010
Record last verified: 2010-01