CClinicalTrials.gg
CompletedNCT00930319FASTUpdated Nov 9, 2023

Effectiveness and Safety of Firmagon®

An observational study in Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma, sponsored by Ferring Pharmaceuticals. Completed at 231 sites in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-09.

Sponsored by Ferring Pharmaceuticals · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
676
Ages
18 Years and older
Sex
Male
01

Study 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.

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Conditions studied

  • Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 676 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with Advanced Hormone-dependent Prostate Carcinoma

Inclusion criteria

  • therapeutic need according to SPC
  • written informed consent

Exclusion criteria

Exclusion Criteria:

  • contraindications according to SPC
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
676 participants (actual)

Groups and cohorts

  • 1

    Patients with Advanced Hormone-dependent Prostate Carcinoma treated with Firmagon according to SPC

    Other: Firmagon given by prescription according to SPC

Interventions

  • OtherFirmagon given by prescription according to SPC

    Non-interventional,observational Firmagon given by prescription according to SPC

06

What researchers measure

Primary outcomes

  1. duration of the PSA progression-free survival

    Time frame: open (until therapy end or stop)

Secondary outcomes

  1. 1. testosterone levels

    Time frame: open (until therapy end or stop)

  2. 2. number of ADRs and SUSARs

    Time frame: open (until therapy end or stop)

  3. 3. quality of life

    Time frame: open (until therapy end or stop)

07

Study locations

231 sites
  • Investigational Site, Heinrich-Rieger-Str. 15
    Aalen, Germany
  • Investigational Site, Weidenfelder Straße 1
    Aalen, Germany
  • Investigational Site
    Abensberg, Germany
  • Investigational Site
    Ahaus, Germany
  • Investigational Site
    Ahrensburg, Germany
  • Investigational Site
    Alsdorf, Germany
  • Investigational Site
    Alsfeld, Germany
  • Investigational Site
    Altenburg, Germany
  • Investigational Site
    Andernach, 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
    Bad Godesberg, Germany
  • Investigational Site
    Bad Marienberg, Germany
  • Investigational Site
    Bad Oldesloe, Germany
  • Investigational Site
    Bad Salzuflen, Germany
  • Investigational Site
    Bad Schönborn, Germany
  • Investigational Site
    Bad Wildungen, Germany
  • Investigational Site
    Bautzen, Germany
  • Investigational Site
    Bergzabern, Germany
  • Investigational Site, Albert-Einstein-Straße 2
    Berlin, Germany
  • Investigational Site, Allee der Kosmonauten 47
    Berlin, Germany
  • Investigational Site, Hohenzollerndamm 47a
    Berlin, Germany
  • Investigational Site, Lipschitzallee 20
    Berlin, Germany
  • Investigational Site, Mehrower Allee 22
    Berlin, Germany
  • Investigational Site, Pasteurstraße 8
    Berlin, Germany
  • Investigational Site, Rudolff-Seifert-Straße 11
    Berlin, Germany
  • Investigational Site, Wisbyer Straße 16
    Berlin, Germany
  • Investigational Site, Zeppelinring 7
    Biberach, Germany
  • Investigational Site
    Biedenkopf, Germany
  • Investigational Site, Elbeallee 83
    Bielefeld, Germany
  • Investigational Site, Friedrich-Verleger Straße 5
    Bielefeld, Germany
  • Investigational Site, Johannisstraße 43
    Bielefeld, Germany
  • Investigational Site, Treppenstraße 3
    Bielefeld, Germany
  • Investigational Site
    Bitterfeld, Germany
  • Investigational Site
    Bocholt, Germany
  • Investigational Site, St. Augustiner-Straße 21
    Bonn, Germany
  • Investigational Site, Trierer Straße 70 - 72
    Bonn, Germany
  • Investigational Site
    Borken, Germany
  • Investigational Site
    Bramsche, Germany
  • Investigational Site
    Braunschweig, Germany
  • Investigational Site
    Bremen, Germany
  • Investigational Site, Dr.-Franz-Mertens-Straße 8
    Bremerhaven, Germany
  • Investigational Site, Georgstraße 44
    Bremerhaven, Germany
  • Investigational Site
    Bruchköbel, Germany
  • Investigational Site
    Buchholz, Germany
  • Investigational Site
    Burg, Germany
  • Investigational Site
    Bünde, Germany
  • Investigational Site
    Celle, Germany
  • Investigational Site, Carl-von-Ossietzky-Str. 151
    Chemnitz, Germany
  • Investigational Site, Clausstraße 44
    Chemnitz, Germany
  • Investigational Site, Flemmingstraße 1b
    Chemnitz, Germany
  • Investigational Site, Unritzstraße 21 c
    Chemnitz, Germany
  • Investigational Site
    Coburg, Germany
  • Investigational Site
    Cottbus, Germany
  • Investigational Site, Karlstraße 30
    Crailsheim, Germany
  • Investigational Site, Postplatz 2
    Crailsheim, Germany
  • Investigational Site
    Delitzsch, Germany
  • Investigational Site
    Dessau-Roßlau, Germany
  • Investigational Site
    Dessau, Germany
  • Investigational Site
    Dillenburg, Germany
  • Investigational Site
    Dinslaken, Germany
  • Investigational Site
    Dortmund, Germany
  • Investigational Site
    Dossenheim, Germany
  • Investigational Site
    Dresden, Germany
  • Investigational Site, Kreuzstraße 3-5
    Duisburg, Germany
  • Investigational Site, Königstraße 49
    Duisburg, Germany
  • Investigational Site
    Dülmen, Germany
  • Investigational Site
    Düsseldorf, Germany
  • Investigational Site
    Eisenhüttenstadt, Germany
  • Investigational Site, Geschwister-Scholl-Str. 6
    Erfurt, Germany
  • Investigational Site, Juri-Gagarin-Ring 94
    Erfurt, Germany
  • Investigational Site
    Essen, Germany
  • Investigational Site
    Finsterwalde, Germany
  • Investigational Site, Eschersheimer Landstr. 544
    Frankfurt, Germany
  • Investigational Site, Im Steinbügel 13
    Frankfurt, Germany
  • Investigational Site
    Freiburg, Germany
  • Investigational Site
    Freital, Germany
  • Investigational Site
    Friedberg, Germany
  • Investigational Site
    Friedrichshafen, Germany
  • Investigational Site, Arminstraße 24
    Gelsenkirchen, Germany
  • Investigational Site, Feldmarkstraße 109
    Gelsenkirchen, Germany
  • Investigational Site, Zum Ehrenmal 21
    Gelsenkirchen, Germany
  • Investigational Site
    Gera, Germany
  • Investigational Site
    Gießen, Germany
  • Investigational Site, Helenenstraße 10-12
    Gotha, Germany
  • Investigational Site, Schützenberg 10
    Gotha, Germany
  • Investigational Site
    Grimma, Germany
  • Investigational Site, Steinweg 27
    Halle (Saale), Germany
  • Investigational Site, Niemeyerstraße 23
    Halle, Germany
  • Investigational Site, Reilstraße 129 a
    Halle, Germany
  • Investigational Site, Alte Holstenstraße 16
    Hamburg, Germany
  • Investigational Site, Fuhlsbüttler Straße 182
    Hamburg, Germany
  • Investigational Site, Grindelberg 3
    Hamburg, Germany
  • Investigational Site, Herthastraße 12
    Hamburg, Germany
  • Investigational Site, Tangstedter Landstraße 77
    Hamburg, Germany
  • Investigational Site
    Hattersheim, Germany
  • Investigational Site
    Heidelberg, Germany
  • Investigational Site
    Heilbronn, Germany

Showing the first 100 of 231 sites.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00930319
Lead sponsor
Ferring Pharmaceuticals
Collaborators
Ferring Arzneimittel GmbH
Responsible party
Sponsor
First posted
Jun 30, 2009
Start date
Jun 2009
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Nov 9, 2023

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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