Comparison of Two Pharmacological Treatments of Pedophilia (PCNET)

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

Status and phase: Terminated; Phase 3

Conditions: Pedophilia

Treatments: Drug: Cyproterone acetate; Drug: leuprorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT00601276

RBM-0315

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: leuprorelin

2

Active Comparator group

Treatment:

Drug: Cyproterone acetate