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Comparison of Two Pharmacological Treatments of Pedophilia (PCNET)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00601276
First Posted: January 28, 2008
Last Update Posted: July 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
December 3, 2007
January 28, 2008
July 13, 2009
December 2007
June 2009   (Final data collection date for primary outcome measure)
Questionnaire on sexual behavior [ Time Frame: prospective ]
Same as current
Complete list of historical versions of study NCT00601276 on ClinicalTrials.gov Archive Site
Recidivism [ Time Frame: Prospective ]
Same as current
Not Provided
Not Provided
 
Comparison of Two Pharmacological Treatments of Pedophilia
Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pedophilia
  • 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
  • Experimental: 1
    Intervention: Drug: leuprorelin
  • Active Comparator: 2
    Intervention: Drug: Cyproterone acetate
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.
 
Terminated
48
June 2009
June 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00601276
RBM-0315
Yes
Not Provided
Not Provided
Dr Stoleru, Inserm
Institut National de la Santé Et de la Recherche Médicale, France
  • Assistance Publique - Hôpitaux de Paris
  • Ministry of Health, France
  • Ministry of Higher Education and Research, France
Study Director: Serge Stoleru, MD, PHD Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
December 2007

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