Comparison of Two Pharmacological Treatments of Pedophilia

Pedophilia Clinical Trial

— PCNET  

Official title:

Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00601276
• Other study ID #: RBM-0315
• Status: Terminated
• Phase: Phase 3
• First received: December 3, 2007
• Last updated: July 10, 2009
• Start date: December 2007
• Est. completion date: June 2009

Study information

• Verified date: December 2007
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pedophilia

Intervention

Drug:
• leuprorelin
Subcutaneous injection, 3.75 mg every 4 weeks
• Cyproterone acetate
2.0 mg/kg/day, tablet, per os

Locations

Country	Name	City	State
France	Federation d'Endocrinologie, Hopital NeuroCardiologique	Bron
France	Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse	Paris
France	Service de Psychiatrie, Hopital Foch	Suresnes
France	SMPR, Hopital Paul Guiraud	Villejuif

Sponsors (4)

Lead Sponsor	Collaborator
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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire on sexual behavior		prospective	No
Secondary	Recidivism		Prospective	No