Effectiveness and Safety of Firmagon®

Completed

• Conditions: Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma

• Registration Number: NCT00930319
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

Effectiveness and Safety of Firmagon® in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma. The period until Prostate Specific Antigen (PSA) progression during the Firmagon® therapy is to be documented and related to the testosterone values measured in the course of therapy (if available). Other clinical parameters, the patients' quality of life and the direct and indirect costs incurred by the medical care for the advanced hormone-dependent prostate carcinoma and its consequences will be evaluated. In this context the medical outcome and the life quality are defined as effectiveness and benefit value parameters. Both the effectiveness under daily life circumstances and economic variables of the therapy can thus be shown and compared within an analysis of costs vs. benefits or costs vs. effectiveness.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-03
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 676

Inclusion Criteria

• therapeutic need according to SPC
• written informed consent

Exclusion Criteria

• contraindications according to SPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
duration of the PSA progression-free survival	open (until therapy end or stop)

Secondary Outcome Measures

Name	Time	Method
3. quality of life	open (until therapy end or stop)
2. number of ADRs and SUSARs	open (until therapy end or stop)
1. testosterone levels	open (until therapy end or stop)

Trial Locations

Locations (88)

Investigational Site, Heinrich-Rieger-Str. 15; 🇩🇪 Aalen, Germany

Investigational Site, Weidenfelder Straße 1; 🇩🇪 Aalen, Germany

Investigational Site; 🇩🇪 Überlingen, Germany

Investigational Site, Endresstraße 12; 🇩🇪 Ansbach, Germany

Investigational Site, Platenstraße 15; 🇩🇪 Ansbach, Germany

Investigational Site, Frölichstraße 13; 🇩🇪 Augsburg, Germany

Investigational Site, Prinzregentenstraße 4; 🇩🇪 Augsburg, Germany

Investigational Site, Albert-Einstein-Straße 2; 🇩🇪 Berlin, Germany

Investigational Site, Allee der Kosmonauten 47; 🇩🇪 Berlin, Germany

Investigational Site, Hohenzollerndamm 47a; 🇩🇪 Berlin, Germany

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