PCNET: Comparison of Two Pharmacological Treatments of Pedophilia

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Terminated

CT.gov ID

NCT00601276

Collaborator

Assistance Publique - Hôpitaux de Paris (Other), Ministry of Health, France (Other), Ministry of Higher Education and Research, France (Other)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pedophilia	Drug: leuprorelin Drug: Cyproterone acetate	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

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

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: leuprorelin Subcutaneous injection, 3.75 mg every 4 weeks Other Names: Enantone
Active Comparator: 2	Drug: Cyproterone acetate 2.0 mg/kg/day, tablet, per os Other Names: Androcur

Arm

Intervention/Treatment

Experimental: 1

Drug: leuprorelin

Subcutaneous injection, 3.75 mg every 4 weeks

Other Names:

Enantone

Active Comparator: 2

Drug: Cyproterone acetate

2.0 mg/kg/day, tablet, per os

Other Names:

Androcur

Outcome Measures

Primary Outcome Measures

Questionnaire on sexual behavior [prospective]

Secondary Outcome Measures

Recidivism [Prospective]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Federation d'Endocrinologie, Hopital NeuroCardiologique	Bron	France	69500
2	Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse	Paris	France	75017
3	Service de Psychiatrie, Hopital Foch	Suresnes	France	92150
4	SMPR, Hopital Paul Guiraud	Villejuif	France	94800