Retrospective, Non-Interventional Study of Depo-Eligard®. - Tabular View

Tracking Information

First Received Date ^ICMJE

December 17, 2008

Last Updated Date

May 19, 2009

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard® [ Time Frame: After at least 6 months treatment with Depo-Eligard ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00811876 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Measurement of PSA and testosterone levels if available [ Time Frame: After at least 6 months treatment with Depo-Eligard ] [ Designated as safety issue: No ]
Overall evaluation of efficacy [ Time Frame: After a least 6 months treatment with Depo-Eligard ] [ Designated as safety issue: No ]
Overall patient assessment of treatment benefit [ Time Frame: After at least 6 months treatment with Depo-Eligard ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Retrospective, Non-Interventional Study of Depo-Eligard®.

Official Title ^ICMJE

Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-Interventional Clinical Trial

Brief Summary

Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment

Detailed Description

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Retrospective

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Other: Data Collection on Depo-Eligard exposure

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

350

Estimated Completion Date

September 2009

Estimated Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Astellas Pharma Belgium Medical Department

+32 2 558 0739

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00811876

Responsible Party

Disclosure Office Europe, Astellas Pharma Europe BV

Study ID Numbers ^ICMJE

BE-08-EGD-02

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use Central Contact

Astellas Pharma Europe BV

Information Provided By

Astellas Pharma Inc

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP