跳至主要内容
临床试验/EUCTR2018-001049-15-SE
EUCTR2018-001049-15-SE进行中(未招募)1 期

Pharmacological treatment of hypersexual disorder; an open pilot study to evaluate the feasibility and effectiveness of treatment with Naltrexone - HD-Trex

ANOVA (Andrologi, Sexualmedicin, Transmedicin) Karolinska Universitetssjukhuset och Umeå Universitet0 个研究点目标入组 20 人开始时间: 2018年6月20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
20

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
All

入选标准

  • A diagnosis of hypersexual disorder (as described in the protocol).
  • 18- 65 years old
  • Signed informed consent
  • Able to understand the Swedish language orally and in written, write in Swedish and able to use the internet including having succeeded in filling out online questionnaires.
  • Willing to participate to all study visits including giving blood and urine samples.
  • 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 20
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Elevated liver enzymes (greater than three times the upper limit of normal for ALAT and/or ASAT).
  • Ongoing opioid or benzodiazepine medication.
  • Illicit self-reported use of drugs in the past month or positive drug verification analysis.
  • Risk consumption of alcohol in the past month or alcohol dependence (14 units of alcohol per week for men and 9 units per week for women will be considered risk consumption).
  • Severe psychiatric disorder such as current psychotic illness or severe depression requiring immediate treatment.
  • History of liver or kidney failure.
  • Serious physical illness.
  • Change of medication or dosage in the last 3 months regarding antidepressants, ADHD-medication, mood stabilizers, anti-psychotics, cortisone, testosterone or precursor of Dopamine such as L-Dopa.
  • Pregnancy and/or breast-feeding.
  • Ongoing psycho-therapeutic treatment.
  • History of allergic reaction to Naltrexone or its metabolites.
  • Other factors that are clinical significant and could jeopardize study results or its intention, as judged by study psychiatrist or psychologist.

研究者

发起方
ANOVA (Andrologi, Sexualmedicin, Transmedicin) Karolinska Universitetssjukhuset och Umeå Universitet

相似试验