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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
  Purpose

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.


Condition Intervention Phase
Pedophilia Drug: leuprorelin Drug: Cyproterone acetate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Questionnaire on sexual behavior [ Time Frame: prospective ]

Secondary Outcome Measures:
  • Recidivism [ Time Frame: Prospective ]

Estimated Enrollment: 48
Study Start Date: December 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: leuprorelin
Subcutaneous injection, 3.75 mg every 4 weeks
Other Name: Enantone
Active Comparator: 2 Drug: Cyproterone acetate
2.0 mg/kg/day, tablet, per os
Other Name: Androcur

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601276


Locations
France
Federation d'Endocrinologie, Hopital NeuroCardiologique
Bron, France, 69500
Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse
Paris, France, 75017
Service de Psychiatrie, Hopital Foch
Suresnes, France, 92150
SMPR, Hopital Paul Guiraud
Villejuif, France, 94800
Sponsors and Collaborators
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
Investigators
Study Director: Serge Stoleru, MD, PHD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Stoleru, Inserm
ClinicalTrials.gov Identifier: NCT00601276     History of Changes
Other Study ID Numbers: RBM-0315
First Submitted: December 3, 2007
First Posted: January 28, 2008
Last Update Posted: July 13, 2009
Last Verified: December 2007

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
pedophilia
antiandrogens
gonadotropin releasing hormone agonists

Additional relevant MeSH terms:
Pedophilia
Paraphilic Disorders
Mental Disorders
Cyproterone
Cyproterone Acetate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents