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Comparison of Two Pharmacological Treatments of Pedophilia (PCNET)

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ClinicalTrials.gov Identifier: NCT00601276
Recruitment Status : Terminated
First Posted : January 28, 2008
Last Update Posted : July 13, 2009
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Ministry of Higher Education and Research, France
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date  ICMJE December 3, 2007
First Posted Date  ICMJE January 28, 2008
Last Update Posted Date July 13, 2009
Study Start Date  ICMJE December 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Questionnaire on sexual behavior [ Time Frame: prospective ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2008)
Recidivism [ Time Frame: Prospective ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Pharmacological Treatments of Pedophilia
Official Title  ICMJE Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia
Brief Summary

Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims.

Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pedophilia
Intervention  ICMJE
  • Drug: leuprorelin
    Subcutaneous injection, 3.75 mg every 4 weeks
    Other Name: Enantone
  • Drug: Cyproterone acetate
    2.0 mg/kg/day, tablet, per os
    Other Name: Androcur
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: leuprorelin
  • Active Comparator: 2
    Intervention: Drug: Cyproterone acetate
Publications * Moulier V, Fonteille V, Pélégrini-Issac M, Cordier B, Baron-Laforêt S, Boriasse E, Durand E, Stoléru S. A pilot study of the effects of gonadotropin-releasing hormone agonist therapy on brain activation pattern in a man with pedophilia. Int J Offender Ther Comp Criminol. 2012 Feb;56(1):50-60. doi: 10.1177/0306624X10392191. Epub 2011 Apr 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: January 15, 2008)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical diagnosis of pedophilia
  • high frequency of sexual urges and deviant behavior as demonstrated by a score equal to 8 on the scale of Rösler & Witztum (Rösler & Witztum, 1998) ;
  • age: 18-60 years
  • informed consent

Exclusion Criteria:

  • IQ<70
  • schizophrenia, schizoaffective disorder, or delusional disorder
  • already receiving one of the tested drugs
  • contraindication for one of the tested drugs
  • no current or planned incarceration
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00601276
Other Study ID Numbers  ICMJE RBM-0315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Stoleru, Inserm
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE
  • Assistance Publique - Hôpitaux de Paris
  • Ministry of Health, France
  • Ministry of Higher Education and Research, France
Investigators  ICMJE
Study Director: Serge Stoleru, MD, PHD Institut National de la Santé Et de la Recherche Médicale, France
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP