跳至主要内容
临床试验/NCT03879746
NCT03879746Unknown3 期

Effect of Tamsulosin on Premature Ejaculation Compared With Paroxetine Hydrochloride

Assiut University0 个研究点目标入组 160 人开始时间: 2019年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
160
主要终点
Premature Ejaculation Diagnostic Tool

研究概览

简要总结

A study to compare the effect of tamsulosin versus the effect of paroxetine hydrochloride and the effect of combination of them on PE.

详细描述

Premature ejaculation is considered the most common male sexual disorder. affecting approximately 4-39 % of men in general community. In 2008, the International Society for Sexual Medicine defined premature ejaculation as a male sexual dysfunction that is characterized by ejaculation that always or nearly always occurs within or before 1 minute of vaginal penetration. Moreover it is associated with presence of distress, frustration, bother, negative personal consequences, depression and the avoidance of sexual intimacy.

Many etiological theories have been included in the pathogenesis of premature ejaculation: neurobiological, psychological, environmental and endocrine factors. So a lot of therapeutic modalities, such as behavioral therapy, selective serotonin reuptake inhibitors (SSRIs), adrenergic alpha 1 antagonists, local anesthetic creams, clomipramine, phosphodiesterase type 5 inhibitors and centrally acting analgesics have been used for the treatment of premature ejaculation.

Previous studies reported that tamsulosin which is alpha blocker agent used as primary therapeutic agent for BPH is effective in the improvement of sexual function. However studies on the effect of tamsulosin on ejaculation reported that tamsulosin had inhibitory effect in the emission phase of ejaculation including decreased ejaculatory volume. So inhibitory effect of tamsulosin on ejaculation may be beneficial to patients suffering from premature ejaculation.

Historically, PE was considered psychological problem and was treated by behavioral treatment and psychotherapy but there is pharmacological studies increase the evidence that PE may be related to decreased serotonergic neurotransmission. So selective serotonin reuptake inhibitors (SSRIs ) such as : paroxetine, fluoxetine, dapoxetine, and sertraline are among the recommended pharmacological treatments for treating PE. But there is no universal agreement on the type, the dose and administration protocol.

So a study is needed to compare the value of combination therapy of both tamsulosin and paroxetine with the value of single therapy of either of them and consider Intravaginal Ejaculatory Latency Time (IELT) and ejaculatory control ability of patients after using tamsulosin and paroxetine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Married, sexually active patients with PE will be included with ages ranging from 20 to 60 years.

排除标准

  • Patients suffering from erectile dysfunction, DM, HTN, neurological disorders and psychological disorders.

研究组 & 干预措施

tamsulosin group

Active Comparator

the first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg

干预措施: Tamsulosin (Drug)

paroxetine group

Active Comparator

the second group will include 40 patients treated with daily administration of paroxetine 20 mg

干预措施: Paroxetine Hydrochloride (Drug)

combined group

Active Comparator

the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg

干预措施: Tamsulosin (Drug)

combined group

Active Comparator

the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg

干预措施: Paroxetine Hydrochloride (Drug)

placrbo group

Placebo Comparator

the fourth group will include 40 patients will be given placebo

干预措施: placebo (Other)

结局指标

主要结局

Premature Ejaculation Diagnostic Tool

时间窗: 3 months

Patients will be asked to complete the PEDT ( Premature Ejaculation Diagnostic Tool ) Cases will be scored as follow : * Score of less than or equal 8 indicate no PE . * Score of 9 and 10 indicate probable PE . * Score of more than or equal 11 indicate PE After about 12 weeks the patients will be reevaluated also by ( PEDT ) and the results will be compared with the pretreatment ones

次要结局

  • Intravaginal Ejaculatory Latency Time(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Farrag

Principal Investigator

Assiut University

相似试验