title: [Failure of a study in forensic psychiatric hospitals : Clinical trial to investigate the additive effect of triptorelin on the efficacy of psychotherapy].
abstract: BACKGROUND
  A testosterone-lowering medication is relatively commonly used as a form of treatment for sexual offenders with severe paraphilic disorders in German forensic psychiatric hospitals; however, a double-blind, controlled and randomized study, which investigates the efficacy of this medication, is still lacking.
  
  
  OBJECTIVE
  This article describes the process from the planning to the rejection of a clinical trial over the period from 2009 to 2015.
  
  
  RESULTS
  Despite the careful planning with an interdisciplinary team and giving special consideration to the complex legal situation, the Federal Institute for Drugs and Medical Devices (BfArM) rejected the proposed trial in a brief formal letter with reference to the German Drug Law (§ 40 para. 1 p. 3 nr. 4 AMG). The ethics committee of the Hamburg Medical Association considered that clinical research is basically not possible with patients detained in a forensic psychiatric hospital.
  
  
  CONCLUSIONS
  In the opinion of the authors, the described facts illustrate how legal regulations that should protect vulnerable groups in medical research, in a specific case can lead to the fact that a therapy form relevant to the corresponding patient group cannot be scientifically investigated.
authors.affiliation: Institut für Sexualforschung und Forensische Psychiatrie, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Deutschland. briken@uke.de.
authors.forename: Peer
authors.initials: P
authors.lastname: Briken
authors.affiliation: Asklepiosklinik für Forensische Psychiatrie Göttingen, Georg August Universität Göttingen, Rosdorfer Weg 70, 37081, Göttingen, Deutschland.
authors.forename: Jürgen L
authors.initials: JL
authors.lastname: Müller
authors.affiliation: Institut für Sexualforschung und Forensische Psychiatrie, Universitätsklinikum Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Deutschland.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Berner
authors.affiliation: Institut für Medizinische Informatik, Justus-Liebig-Universität Gießen, Rudolf-Buchheim-Str. 6, 35392, Gießen, Deutschland.
authors.forename: Rolf-Hasso
authors.initials: RH
authors.lastname: Bödeker
authors.affiliation: Medizinische Ethik und Geschichte der Medizin, Ruhr-Universität Bochum, Malakowturm -- Markstr. 258a, 44799, Bochum, Deutschland.
authors.forename: Jochen
authors.initials: J
authors.lastname: Vollmann
authors.affiliation: Innere Medizin I und Klinische Chemie, Medizinische Universitätsklinik Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Deutschland.
authors.forename: Christian
authors.initials: C
authors.lastname: Kasperk
authors.affiliation: Vorsitzender Richter am Landgericht, Landgericht Göttingen, Berliner Straße 8, 37073, Göttingen, Deutschland.
authors.forename: Matthias
authors.initials: M
authors.lastname: Koller
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D005555:Forensic Psychiatry / Q000941:ethics*; D005858:Germany; D006778:Hospitals, Psychiatric / Q000941:ethics*; D006801:Humans; D008297:Male; D010262:Paraphilic Disorders / Q000517:prevention & control* / Q000523:psychology; D011613:Psychotherapy / Q000941:ethics* / Q000379:methods; D017329:Triptorelin Pamoate / Q000008:administration & dosage*
chemical_list: D017329:Triptorelin Pamoate
keywords: Drug legislation; Ethics committee; Pedophilia; Sexual offenders; Testosterone