Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation A Double-Blind, Placebo-Controlled, Fixed-Dose,Randomized Controlled Study
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- change in geometric mean IELT from baseline to four weeks.
研究概览
简要总结
Escitalopram has been claimed to have the highest selectivity for the human serotonin transporter relative to the noradrenaline or dopamine transporters. This might be associated with greater clinical efficacy. Most adverse events reported by escitalopram-treated patients are mild and transient.
In this study, we compare escitalopram with placebo in the treatment of PE.
详细描述
Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized controlled Study
Introduction
From an epidemiological perspective, premature ejaculation (PE) has been reported as the most common male sexual dysfunction with overall prevalence rates estimated at around 30% .(Laumann et al., 1999).
PE is defined by the Diagnostic and Statistical Manual of Mental Disorders(revision IV) (DSM-IV-TR) as 'the persistent or recurrent ejaculation with minimal stimulation before, on, or shortly after penetration and before the person wishes it'. (American Psychiatric Association, 1994).
ISSM Definition of Premature Ejaculation is a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy (www.issm.info).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •One hundred married patients seek medical help for what they consider premature ejaculation with possible sexual intercourse equal or greater than 1 per week.
排除标准
- •Erectile dysfunction accounting to Arabic version of IIEF(International Index of Erectile Dysfunction)
- •Chronic psychiatric or physical illness.
- •Alcohol or substance abuse.
- •Use of psychotropic and antidepressant medication.
- •Patient with prostatitis
- •Organic illness causing limitation of SSRI use.
结局指标
主要结局
change in geometric mean IELT from baseline to four weeks.
时间窗: 4 week
次要结局
- changes in the intercourse satisfaction domain values of IIEF(Arabic version). Assessment of possible side effects(4 week)