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Comparison of Two Pharmacological Treatments of Pedophilia (PCNET)

This study has been terminated.
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
French Ministry of Research
Information provided by:
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT00601276
First received: December 3, 2007
Last updated: July 10, 2009
Last verified: December 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recidivism [ Time Frame: Prospective ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
French Ministry of Research
Investigators
Study Director: Serge Stoleru, MD, PHD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided by Institut National de la Santé Et de la Recherche Médicale, France

Additional 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
Study First Received: December 3, 2007
Last Updated: July 10, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Paraphilias
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Cyproterone
Cyproterone Acetate
Diane
Leuprolide
Androgen Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Fertility Agents, Female
Fertility Agents

ClinicalTrials.gov processed this record on May 23, 2013