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

NCT ID: NCT00811876

Last Updated: 2010-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Data Collection on Depo-Eligard exposure

Retrospective, Non-interventional

Intervention Type OTHER

Other Intervention Names

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leuproreline acetate exposure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma Europe BV

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Europe B.V.

Locations

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Antwerp, , Belgium

Site Status

Berlaar, , Belgium

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Bornem, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Charleroi, , Belgium

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Ghent, , Belgium

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Jemeppe, , Belgium

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Kortrijk, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Lommel, , Belgium

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Merksem, , Belgium

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Mons, , Belgium

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Mortsel, , Belgium

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Ragnies, , Belgium

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Tienen, , Belgium

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Tongeren, , Belgium

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Turnhout, , Belgium

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Waregem, , Belgium

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Willebroek, , Belgium

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Yvoir, , Belgium

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Countries

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Belgium

Other Identifiers

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BE-08-EGD-02

Identifier Type: -

Identifier Source: org_study_id

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