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.
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