Effectiveness and Safety of Firmagon®

NCT ID: NCT00930319

Last Updated: 2023-11-09

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

676 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Androgen Ablative Therapy of Advanced Hormone-dependent Prostate Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

Firmagon given by prescription according to SPC

Intervention Type OTHER

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

Interventions

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Firmagon given by prescription according to SPC

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* therapeutic need according to SPC
* written informed consent

Exclusion Criteria

\- contraindications according to SPC
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Arzneimittel GmbH

INDUSTRY

Sponsor Role collaborator

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Investigational Site, Heinrich-Rieger-Str. 15

Aalen, , Germany

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Investigational Site, Weidenfelder Straße 1

Aalen, , Germany

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Abensberg, , Germany

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Ahaus, , Germany

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Ahrensburg, , Germany

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Alsdorf, , Germany

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Alsfeld, , Germany

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Altenburg, , Germany

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Andernach, , Germany

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Investigational Site, Endresstraße 12

Ansbach, , Germany

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Investigational Site, Platenstraße 15

Ansbach, , Germany

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Investigational Site, Frölichstraße 13

Augsburg, , Germany

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Investigational Site, Prinzregentenstraße 4

Augsburg, , Germany

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Bad Bergzaben, , Germany

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Bad Godesberg, , Germany

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Bad Marienberg, , Germany

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Bad Oldesloe, , Germany

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Bad Salzuflen, , Germany

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Bad Schönborn, , Germany

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Bad Wildungen, , Germany

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Bautzen, , Germany

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Investigational Site, Albert-Einstein-Straße 2

Berlin, , Germany

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Investigational Site, Allee der Kosmonauten 47

Berlin, , Germany

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Investigational Site, Hohenzollerndamm 47a

Berlin, , Germany

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Investigational Site, Lipschitzallee 20

Berlin, , Germany

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Investigational Site, Mehrower Allee 22

Berlin, , Germany

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Investigational Site, Pasteurstraße 8

Berlin, , Germany

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Investigational Site, Rudolff-Seifert-Straße 11

Berlin, , Germany

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Investigational Site, Wisbyer Straße 16

Berlin, , Germany

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Investigational Site, Zeppelinring 7

Biberach, , Germany

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Biedenkopf, , Germany

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Investigational Site, Elbeallee 83

Bielefeld, , Germany

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Investigational Site, Friedrich-Verleger Straße 5

Bielefeld, , Germany

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Investigational Site, Johannisstraße 43

Bielefeld, , Germany

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Investigational Site, Treppenstraße 3

Bielefeld, , Germany

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Bitterfeld-Wolfen, , Germany

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Bocholt, , Germany

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Investigational Site, St. Augustiner-Straße 21

Bonn, , Germany

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Investigational Site, Trierer Straße 70 - 72

Bonn, , Germany

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Borken, , Germany

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Bramsche, , Germany

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Braunschweig, , Germany

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Bremen, , Germany

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Investigational Site, Dr.-Franz-Mertens-Straße 8

Bremerhaven, , Germany

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Investigational Site, Georgstraße 44

Bremerhaven, , Germany

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Bruchköbel, , Germany

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Buchholz, , Germany

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Burg, , Germany

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Bünde, , Germany

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Celle, , Germany

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Investigational Site, Carl-von-Ossietzky-Str. 151

Chemnitz, , Germany

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Investigational Site, Clausstraße 44

Chemnitz, , Germany

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Investigational Site, Flemmingstraße 1b

Chemnitz, , Germany

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Investigational Site, Unritzstraße 21 c

Chemnitz, , Germany

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Coburg, , Germany

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Investigational Site, Custodistraße 3-17

Cologne, , Germany

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Investigational Site, Wilhelm-Ewald-Weg 1

Cologne, , Germany

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Investigational Site, Zeppelinstraße 1

Cologne, , Germany

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Cottbus, , Germany

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Investigational Site, Karlstraße 30

Crailsheim, , Germany

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Crailsheim, , Germany

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Delitzsch, , Germany

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Dessau, , Germany

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Dillenburg, , Germany

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Dinslaken, , Germany

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Dortmund, , Germany

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Dossenheim, , Germany

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Dresden, , Germany

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Duisburg, , Germany

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Duisburg, , Germany

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Dülmen, , Germany

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Düsseldorf, , Germany

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Eisenhüttenstadt, , Germany

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Erfurt, , Germany

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Erfurt, , Germany

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Essen, , Germany

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Finsterwalde, , Germany

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Investigational Site, Eschersheimer Landstr. 544

Frankfurt, , Germany

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Investigational Site, Im Steinbügel 13

Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Freital, , Germany

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Friedberg, , Germany

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Friedrichshafen, , Germany

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Investigational Site, Arminstraße 24

Gelsenkirchen, , Germany

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Gelsenkirchen, , Germany

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Gelsenkirchen, , Germany

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Gera, , Germany

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Giessen, , Germany

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Gotha, , Germany

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Gotha, , Germany

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Grimma, , Germany

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Investigational Site, Niemeyerstraße 23

Halle, , Germany

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Investigational Site, Reilstraße 129 a

Halle, , Germany

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Investigational Site, Steinweg 27

Halle, , Germany

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Investigational Site, Alte Holstenstraße 16

Hamburg, , Germany

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Investigational Site, Fuhlsbüttler Straße 182

Hamburg, , Germany

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Investigational Site, Grindelberg 3

Hamburg, , Germany

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Hamburg, , Germany

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Investigational Site, Tangstedter Landstraße 77

Hamburg, , Germany

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Hattersheim, , Germany

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Heidelberg, , Germany

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Heilbronn, , Germany

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Heinsberg, , Germany

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Herford, , Germany

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Hof, , Germany

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Hof, , Germany

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Isenburg, , Germany

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Jena, , Germany

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Jülich, , Germany

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Kaiserslautern, , Germany

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Kamenz, , Germany

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Kamp-Lintfort, , Germany

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Karlsruhe, , Germany

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Kempten, , Germany

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Kiel, , Germany

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Kiel, , Germany

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Kiel, , Germany

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Kleinblittersdorf, , Germany

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Köthen, , Germany

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Köthen, , Germany

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Krefeld, , Germany

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Kulmbach, , Germany

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Lampertheim, , Germany

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Langenau, , Germany

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Lebach, , Germany

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Leutkirch, , Germany

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Lichtenfels, , Germany

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Limbach-Oberfrohna, , Germany

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Lubnjow, , Germany

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Ludwigshafen, , Germany

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Lübeck, , Germany

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Lünen, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Mannheim, , Germany

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Marburg, , Germany

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Marl, , Germany

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Mechernich, , Germany

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Merseburg, , Germany

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Merzig, , Germany

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Michelstadt, , Germany

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Miltenberg, , Germany

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Moers, , Germany

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Mölln, , Germany

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Mörlenbach, , Germany

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Mühlacker, , Germany

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Mühlhausen, , Germany

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Mühlheim, , Germany

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Münster, , Germany

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Münster, , Germany

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Naumburg, , Germany

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Neu-Ulm, , Germany

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Neunkirchen, , Germany

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Neuss, , Germany

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Nienburg, , Germany

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Norderstedt, , Germany

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Nordhausen, , Germany

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Nordhausen, , Germany

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Nordhorn, , Germany

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Nordhorn, , Germany

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Nuremberg, , Germany

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Investigational Site, Hefnersplatz 1

Nuremberg, , Germany

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Nuremberg, , Germany

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Obernburg, , Germany

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Ochsenfurt, , Germany

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Offenbach, , Germany

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Osnabrück, , Germany

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Paderborn, , Germany

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Pasewalk, , Germany

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Pirna-Copitz, , Germany

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Prüm, , Germany

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Pulheim, , Germany

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Investigational Site, Hindenburgstraße 10 A

Rastatt, , Germany

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Investigational Site, Kaiserstraße 7

Rastatt, , Germany

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Investigational Site, Gartenstraße 22

Ravensburg, , Germany

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Ravensburg, , Germany

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Regensburg, , Germany

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Remscheid, , Germany

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Ribnitz-Damgarten, , Germany

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Rostock, , Germany

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Rostock, , Germany

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Rostock, , Germany

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Rottweil, , Germany

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Röthenbach an der Pegnitz, , Germany

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Investigational Site, Mainzer Straße 105

Saarbrücken, , Germany

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Saarbrücken, , Germany

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Saarlouis, , Germany

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Salzmünde, , Germany

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Schönebeck, , Germany

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Schwandorf in Bayern, , Germany

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Schwäbisch Gmünd, , Germany

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Schwerin, , Germany

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Schwerte, , Germany

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Senden, , Germany

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Sindelfingen, , Germany

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Sömmerda, , Germany

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Investigational Site, Kirchplatz 6a

Spremberg, , Germany

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Spremberg, , Germany

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Stockelsdorf, , Germany

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Stolberg, , Germany

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Stuttgart, , Germany

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Sulzbach-Rosenberg, , Germany

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Tettnang, , Germany

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Tostedt, , Germany

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Trier, , Germany

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Troisdorf, , Germany

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Investigational Site, Hirschstraße 22

Ulm, , Germany

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Investigational Site, Olgastraße 103

Ulm, , Germany

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Investigational Site, Olgastraße 139

Ulm, , Germany

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Überlingen, , Germany

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Velbert, , Germany

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Völklingen, , Germany

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VS-Villingen, , Germany

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Wangen, , Germany

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Investigational Site, Moosbürger Str. 13

Weiden, , Germany

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Investigational Site, Postgasse 1

Weiden, , Germany

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Weißenfels, , Germany

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Werl, , Germany

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Werningerode, , Germany

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Wesel, , Germany

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Wiesbaden, , Germany

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Wilhelmshaven, , Germany

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Investigational Site, Heinrich-Nordhoff-Straße 49

Wolfsburg, , Germany

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Investigational Site, Porschestraße 100

Wolfsburg, , Germany

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Würselen, , Germany

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Xanten, , Germany

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Zerbst, , Germany

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Countries

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Germany

Other Identifiers

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FE200486 CS41

Identifier Type: -

Identifier Source: org_study_id

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