Comparison of Two Pharmacological Treatments of Pedophilia | NCT00601276

Studies
Comparison of Two Pharmacological Treatments of Pedophilia

NCT00601276

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Status

Terminated

Last Update Posted

Jul 13, 2009Estimated

Enrollment

48Estimated

Phase

Phase 3

Conditions

Pedophilia

Interventions

leuprorelin
Cyproterone acetate

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Dec 3, 2007

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2009

Last Update Posted Date

Jul 13, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Institut National de la Santé Et de la Recherche Médicale, FranceOTHER_GOV

Collaborators

Name	Class
Assistance Publique - Hôpitaux de Paris	OTHER
Ministry of Health, France	OTHER_GOV
Ministry of Higher Education and Research, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: leuprorelin
2	Active Comparator		Drug: Cyproterone acetate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
leuprorelin	Drug	Subcutaneous injection, 3.75 mg every 4 weeks	1	Enantone

Measure	Description	Time Frame
Questionnaire on sexual behavior		prospective

Measure	Description	Time Frame
Recidivism		Prospective

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Serge Stoleru, MD, PHD	Institut National de la Santé Et de la Recherche Médicale, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federation d'Endocrinologie, Hopital NeuroCardiologique		Bron		69500	France
Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21518701	Derived	Moulier V, Fonteille V, Pelegrini-Issac M, Cordier B, Baron-Laforet S, Boriasse E, Durand E, Stoleru S. A pilot study of the effects of gonadotropin-releasing hormone agonist therapy on brain activation pattern in a man with pedophilia. Int J Offender Ther Comp Criminol. 2012 Feb;56(1):50-60. doi: 10.1177/0306624X10392191. Epub 2011 Apr 24.

ID	Term
D010262	Paraphilic Disorders
D001523	Mental Disorders

ID	Term
D016729	Leuprolide
D017373	Cyproterone Acetate

ID	Term
D007987	Gonadotropin-Releasing Hormone
D010906	Pituitary Hormone-Releasing Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones