跳至主要内容
临床试验/NCT03583112
NCT03583112Unknown不适用

Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients

Xidian University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年7月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Resting-state brain function measured by Functional magnetic resonance imaging

研究概览

简要总结

Lifelong premature ejaculation (LPE) is a common male sexual dysfunction with a high prevalence in global. Up to now, the etiology of LPE remains unclear. In recent years, dapoxetine, a highly potent serotonin-transporter inhibitor, has been used for treating premature ejaculation. However, the underlying mechanism of dapoxetine was unknown. Recently, with widespread use of neuroimaging techniques, like positron emission tomography and magnetic resonance imaging (MRI) in basic science, researchers can acquire human data on cerebral base of human sexual behavior, not only in normal subjects but also in patients with sexual dysfunction. Therefore, in order to further understand the biological mechanism of LPE and the brain targets of dapoxetine, the present study would investigate the brain changes of LPE and the effect of dapoxetine on brain activation by using MRI technology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •right-handed male Chinese volunteers
  • •intravaginal ejaculatory latency time within 1 min
  • •premature ejaculation diagnostic tool score >11 for patients, but <5 for each control.
  • •patients who never received dapoxetine hydrochloride or other SSRI drugs

排除标准

  • •had medical,neurological or psychiatric disorders
  • •had alcohol, nicotine, or drug abuse
  • •received any treatment at least 2 weeks before the experiment

研究组 & 干预措施

Placebo

Placebo Comparator

In this group, patients received placebo tablet before MRI scan.

干预措施: Placebo Tablet (Drug)

Dapoxetine

Active Comparator

In this group, patients received one dapoxetine hydrochloride tablet before MRI scan.

干预措施: Dapoxetine Hydrochloride Tablet (Drug)

结局指标

主要结局

Resting-state brain function measured by Functional magnetic resonance imaging

时间窗: One day

We will use several indicators to assess the resting-state brain function based on fMRI analysis, including regional homogeneity,Amplitude of Low Frequency Fluctuations, and functional connectivity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验