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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00811876
First received: December 17, 2008
Last updated: January 21, 2010
Last verified: January 2010
History of Changes
  Purpose

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


Condition Intervention
Prostate Cancer
 Other: Data Collection on Depo-Eligard exposure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Data Collection on Depo-Eligard exposure
    Retrospective, Non-interventional
    Other Name: leuproreline acetate exposure
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811876

Locations
Belgium
Antwerpen, Belgium, 2060
Berlaar, Belgium, 2590
Bornem, Belgium, 2880
Brussels, Belgium, 1090
Brussels, Belgium, 1020
Brussels, Belgium, 1070
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
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Director: Use Central Contact Astellas Pharma Europe BV
  More Information

No publications provided

Responsible Party: Disclosure Office Europe, Astellas Pharma Europe BV
ClinicalTrials.gov Identifier: NCT00811876     History of Changes
Other Study ID Numbers: BE-08-EGD-02
Study First Received: December 17, 2008
Last Updated: January 21, 2010
Health Authority: Belgium: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Leuprolide
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013