Overview

Comparison of Two Pharmacological Treatments of Pedophilia

Status:
Terminated
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborators:
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Ministry of Higher Education and Research, France
Treatments:
Cyproterone
Cyproterone Acetate
Leuprolide
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