Comparison of Two Pharmacological Treatments of Pedophilia

Phase 3TerminatedNCT00601276

Institut National de la Santé Et de la Recherche Médicale, France48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pedophilia

Interventions

leuprorelinDRUG

Subcutaneous injection, 3.75 mg every 4 weeks

Cyproterone acetateDRUG

2.0 mg/kg/day, tablet, per os

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (4)

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, France

Outcomes

Primary Outcomes

Questionnaire on sexual behavior

Time frame: prospective

Secondary Outcomes

Recidivism

Time frame: Prospective

Data from ClinicalTrials.gov

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