NCT00601276终止3 期
Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia
Institut National de la Santé Et de la Recherche Médicale, France4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 48
- 试验地点
- 4
- 主要终点
- Questionnaire on sexual behavior
研究概览
简要总结
Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims.
Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of pedophilia
- •high frequency of sexual urges and deviant behavior as demonstrated by a score equal to 8 on the scale of Rösler & Witztum (Rösler & Witztum, 1998) ;
- •age: 18-60 years
- •informed consent
排除标准
- •schizophrenia, schizoaffective disorder, or delusional disorder
- •already receiving one of the tested drugs
- •contraindication for one of the tested drugs
- •no current or planned incarceration
研究组 & 干预措施
1
Experimental
干预措施: leuprorelin (Drug)
2
Active Comparator
干预措施: Cyproterone acetate (Drug)
结局指标
主要结局
Questionnaire on sexual behavior
时间窗: prospective
次要结局
- Recidivism(Prospective)
研究者
研究点 (4)
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