Pedophilia
Conditions
Keywords
pedophilia, antiandrogens, gonadotropin releasing hormone agonists
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.
Interventions
DRUGleuprorelin
Subcutaneous injection, 3.75 mg every 4 weeks
2.0 mg/kg/day, tablet, per os
Sponsors
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Ministry of Higher Education and Research, France
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaire on sexual behavior | prospective |
Secondary
| Measure | Time frame |
|---|---|
| Recidivism | Prospective |
Countries
France
Outcome results
None listed