Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists (EPIPARA)
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|ClinicalTrials.gov Identifier: NCT01743209|
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : September 8, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||213 participants|
|Official Title:||A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743209
|University Hospital of Rouen|
|Rouen, France, 76000|
|Principal Investigator:||Florence THIBAUT, MD/PhD||University Hospital, Rouen|
|Study Chair:||Heloise Delavenne, MD||University Hospital, Rouen|
|Study Chair:||Sandrine LAMY, MD||University Hospital, Rouen|