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Completed

NCT Number: NCT01743209

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

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.

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Key information

Sex eligibility

Male

Study type

Observational

Primary location

University Hospital of Rouen

Rouen, 76000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of paraphilia based on DSM-IV-TR
  • antecedent of sexual offence

Exclusion criteria

  • no diagnostic of paraphilia

Treatment and study plan

Primary outcomes

  1. current deviant sexual activity assessed with the frequency of deviant sexual activity per month

    Time frame: first visit (day 1)

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: EPIPARA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2012
Registry last updated
Sep 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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