Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders and Receiving Androgen Antagonists (EPIPARA)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||A Retrospective Non-interventional Descriptive Epidemiology Study for Patients With Paraphilia Sex Offenders Receiving Androgen Antagonists Treatment|
- current deviant sexual activity assessed with the frequency of deviant sexual activity per month [ Time Frame: first visit (day 1) ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743209
|Contact: Florence THIBAUT, MD/PhDemail@example.com|
|Contact: Heloise DELAVENNE, MDfirstname.lastname@example.org|
|University Hospital of Rouen||Recruiting|
|Rouen, France, 76000|
|Contact: Florence THIBAUT, MD/PhD 00332884442 email@example.com|
|Principal Investigator: Heloise DELAVENNE, MD|
|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|