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临床试验/EUCTR2014-000647-32-SE
EUCTR2014-000647-32-SE进行中(未招募)1 期

Investigation of the efficacy of degarelix as an acute treatment for patients with pedophilic disorder to reduce the risk for sexual child molestation: a prospective, randomized, double blind, and placebo controlled study.

Karolinska University Hospital0 个研究点目标入组 60 人开始时间: 2014年4月8日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • Male >= 18 -65 years
  • Diagnos pedophilia 302.2 according to DSM-5
  • Signed informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 60
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Diagnose of osteporosis
  • Extended QT/QTc ration on ECG (>450 ms)
  • Symptoms or riskfactors known to increase the risk for QT extension (e.g. a history or (family heridity) of cardiac events that indicate a prolongation of QT interval e.g. freqent attacs of syncopé, or propensity to ventricular tachyarrhythmias).
  • On current medical treatment with pharmaceutical substances that could increase QT interval.
  • Known liver disease/function
  • Known kidney disease/function
  • Severe asthma
  • Known allery to IMP and/or IMP excipients
  • Ongoing drugabuse, measured in AUDIT/DUDIT
  • Any indications that MRI measurement are contraindiciated (i.e. metal clips brain etc.)
  • Any other condition that could jepordize the trial scientificly or patients health, as judged by the investigator
  • Particiaption in another clincial trial

研究者

发起方
Karolinska University Hospital

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