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

Paraphilia Clinical Trial

— EPIPARA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743209
• Other study ID #: 2012/057/HP
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: September 5, 2014
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis of paraphilia based on DSM-IV-TR

• antecedent of sexual offence

Exclusion Criteria:

• no diagnostic of paraphilia

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Paraphilia

Locations

Country	Name	City	State
France	University Hospital of Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	current deviant sexual activity assessed with the frequency of deviant sexual activity per month	The primary outcome measure concerns the patient current deviant sexual activity. These data are reported routinely by the patient during his medical consultation and consigned in the medical record.	first visit (day 1)	No