NCT00601276

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 13, 2009

Status Verified

December 1, 2007

Enrollment Period

1.5 years

First QC Date

December 3, 2007

Last Update Submit

July 10, 2009

Conditions

Pedophilia

Keywords

pedophiliaantiandrogensgonadotropin releasing hormone agonists

Outcome Measures

Primary Outcomes (1)

  • Questionnaire on sexual behavior

    prospective

Secondary Outcomes (1)

  • Recidivism

    Prospective

Study Arms (2)

1

EXPERIMENTAL
Drug: leuprorelin

2

ACTIVE COMPARATOR
Drug: Cyproterone acetate

Interventions

leuprorelinDRUG

Subcutaneous injection, 3.75 mg every 4 weeks

Also known as: Enantone
1
Cyproterone acetateDRUG

2.0 mg/kg/day, tablet, per os

Also known as: Androcur
2

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Federation d'Endocrinologie, Hopital NeuroCardiologique

Bron, 69500, France

Location

Centre MédicoPsychologique CMPG21, EPS Perray Vaucluse

Paris, 75017, France

Location

Service de Psychiatrie, Hopital Foch

Suresnes, 92150, France

Location

SMPR, Hopital Paul Guiraud

Villejuif, 94800, France

Location

Related Publications (1)

  • 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.

    PMID: 21518701DERIVED

MeSH Terms

Conditions

Pedophilia

Interventions

LeuprolideCyproterone Acetate

Condition Hierarchy (Ancestors)

Paraphilic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsCyproteronePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Serge Stoleru, MD, PHD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 3, 2007

First Posted

January 28, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 13, 2009

Record last verified: 2007-12

Locations

FR(4)