NCT03879746

Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

Effect of Tamsulosin on Premature Ejaculation Compared With Paroxetine Hydrochloride

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Male
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Premature Ejaculation

Interventions

Type	Name	Description
DRUG	Tamsulosin	drug will be used in treatment of premature ejaculation
DRUG	Paroxetine Hydrochloride	drug will be used in treatment of premature ejaculation
OTHER	placebo	tablets without active substance will be given to patients suffering from premature ejaculation

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-04-01
• Completion: 2020-05-01
• First posted: 2019-03-19
• Last updated: 2019-03-19