Retrospective, Non-interventional Study of Depo-Eligard®. (OCT)

January 21, 2010 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium, 2060
      • Berlaar, Belgium, 2590
      • Bornem, Belgium, 2880
      • Brussels, Belgium, 1090
      • Brussels, Belgium, 1070
      • Brussels, Belgium, 1020
      • Charleroi, Belgium, 6000
      • Gent, Belgium, 9000
      • Jemeppe, Belgium, 4101
      • Kortrijk, Belgium, 8500
      • Leuven, Belgium, 3000
      • Liege, Belgium, 4000
      • Lommel, Belgium, 3290
      • Merksem, Belgium, 2170
      • Mons, Belgium, 7000
      • Mortsel, Belgium, 2640
      • Ragnies, Belgium, 6532
      • Tienen, Belgium, 3300
      • Tongeren, Belgium, 3700
      • Turnhout, Belgium, 2300
      • Waregem, Belgium, 8790
      • Willebroek, Belgium, 2830
      • Yvoir, Belgium, 5530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
After at least 6 months treatment with Depo-Eligard

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of PSA and testosterone levels if available
Time Frame: After at least 6 months treatment with Depo-Eligard
After at least 6 months treatment with Depo-Eligard
Overall evaluation of efficacy
Time Frame: After a least 6 months treatment with Depo-Eligard
After a least 6 months treatment with Depo-Eligard
Overall patient assessment of treatment benefit
Time Frame: After at least 6 months treatment with Depo-Eligard
After at least 6 months treatment with Depo-Eligard

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (Estimate)

December 19, 2008

Study Record Updates

Last Update Posted (Estimate)

January 22, 2010

Last Update Submitted That Met QC Criteria

January 21, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE-08-EGD-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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