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临床试验/NCT01743209
NCT01743209已完成不适用

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

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2012年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
213
试验地点
1
主要终点
current deviant sexual activity assessed with the frequency of deviant sexual activity per month

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
Male
接受健康志愿者

入选标准

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

排除标准

  • no diagnostic of paraphilia

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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