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Comparison of Two Pharmacological Treatments of Pedophilia

NCT00601276 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2009-07-13

No results posted yet for this study

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.

Conditions

  • Pedophilia

Interventions

DRUG

leuprorelin

Subcutaneous injection, 3.75 mg every 4 weeks

DRUG

Cyproterone acetate

2.0 mg/kg/day, tablet, per os

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Ministry of Higher Education and Research, France

    collaborator OTHER_GOV

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

    lead OTHER_GOV

Principal Investigators

  • Serge Stoleru, MD, PHD · Institut National de la Santé Et de la Recherche Médicale, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00601276 on ClinicalTrials.gov