Comparison of Two Pharmacological Treatments of Pedophilia - Full Text View

Comparison of Two Pharmacological Treatments of Pedophilia (PCNET)

This study is currently recruiting participants.
Verified by Institut National de la Santé Et de la Recherche Médicale, France, December 2007

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
Information provided by:	Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:	NCT00601276

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 III

Drug Information available for:

Leuprolide acetate Leuprolide Gonadorelin Gonadorelin hydrochloride LH-RH Cyproterone acetate Cyproterone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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 ] [ 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
Estimated Study Completion Date:	December 2010

Arms	Assigned Interventions
1: Experimental	Drug: leuprorelin Subcutaneous injection, 3.75 mg every 4 weeks
2: Active Comparator	Drug: Cyproterone acetate 2.0 mg/kg/day, tablet, per os

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

Contacts


Contact: Serge G Stoleru, MD	0033144272624	serge.stoleru@snv.jussieu.fr

Locations


France
	Service de Psychiatrie, Hopital Foch	Recruiting
	Suresnes, France, 92150
	SMPR, Hopital Paul Guiraud	Not yet recruiting
	Villejuif, France, 94800
	Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse	Not yet recruiting
	Paris, France, 75017
	Federation d'Endocrinologie, Hopital NeuroCardiologique	Not yet recruiting
	Bron, France, 69500

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

Responsible Party:	Inserm ( Dr Stoleru )
Study ID Numbers:	RBM-0315
First Received:	December 3, 2007
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00601276
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:

pedophilia

antiandrogens

gonadotropin releasing hormone agonists

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological

Leuprolide

Mental Disorders

Cyproterone Acetate

Cyproterone

Pedophilia

Diane

Paraphilias

Additional relevant MeSH terms:

Androgen Antagonists

Contraceptive Agents

Antineoplastic Agents

Therapeutic Uses

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Reproductive Control Agents

Contraceptive Agents, Male

Sexual and Gender Disorders

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 28, 2008