Clinical Trials Directory

Trials / Completed

CompletedNCT01743209

Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists

A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment

Status
Completed
Phase
Study type
Observational
Enrollment
213 (actual)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
Male
Age
Healthy volunteers
Not accepted

Summary

The main objective of the study is to describe the french population of individuals with paraphilia who have committed a sexual offence in whom androgen antagonists was prescribed. The secondary objectives are the description of social demographic profiles, the personal and family histories,psychiatric co-morbidities, the side effects of androgen antagonists treatment. This study, the first of its kind in France, may allow to better understand the social demographic and clinical profile of sexual offenders with paraphilias treated with androgen antagonists. To be included, the subject must have committed a sexual offense and must present a diagnosis of paraphilia with an indication of treatment with androgen antagonists. Paraphilia is defined by the Diagnostic and Statistical Manual as a sexual behavior disorder characterized by "sexually arousing fantasies, needs or recurrent and intense sexual behaviors generally involving (1) of non-human objects, (2) the suffering or humiliation of oneself or partner, (3) children or other persons without their consent, occurring during a period of at least six months "(Criterion A). This disorder is responsible for sexual behavior which is "clinically significant disturbances in social, occupational or other important areas of functioning" (Criterion B). The inclusion of approximately 200 subjects is expected in this study. The inclusion period will last for 12 months. Data will be codified and only a few investigators will have access to these data. The statistical analyse will use the usual descriptive parameters: mean, standard deviation, median, interquartile range and range for quantitative variables, frequencies and cumulative frequencies (if applicable) for qualitative variables.

Conditions

Timeline

Start date
2012-12-01
Primary completion
2014-06-01
Completion
2014-06-01
First posted
2012-12-06
Last updated
2014-09-08

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01743209. Inclusion in this directory is not an endorsement.