Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

Phase 3

• Conditions: Premature Ejaculation
• Interventions: Drug: Paroxetine Hydrochloride; Drug: Tamsulosin; Other: placebo

• Registration Number: NCT03879746
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-14
• Last Update Submitted: 2019-03-14
• Study First Posted: 2019-03-19
• Last Update Posted: 2019-03-19
• Study Start: 2019-04
• Primary Completion: 2020-04
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
paroxetine group	Paroxetine Hydrochloride	the second group will include 40 patients treated with daily administration of paroxetine 20 mg
combined group	Tamsulosin	the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg
combined group	Paroxetine Hydrochloride	the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg
placrbo group	placebo	the fourth group will include 40 patients will be given placebo
tamsulosin group	Tamsulosin	the first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg

Primary Outcome Measures

Name	Time	Method
Premature Ejaculation Diagnostic Tool	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

Secondary Outcome Measures

Name	Time	Method
Intravaginal Ejaculatory Latency Time	3 months	Patients will be asked to measure and record (IELT ) during 2 weeks before starting treatment . then they will be asked to measure and record ( IELT ) after each intercourse during and after period of treatment and will be compared with pretreatment measures