Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

Premature Ejaculation Clinical Trial

Official title:

Effect of Tamsulosin on Premature Ejaculation Compared With Paroxetine Hydrochloride

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03879746
• Other study ID #: premature ejaculation
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 2019
• Est. completion date: May 2020

Study information

• Verified date: March 2019
• Source: Assiut University
• Contact: Asmaa Farrag
• Phone: 201128359948
• Email: asmaafarrag14[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: May 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Ejaculation

Intervention

Drug:
• Tamsulosin
drug will be used in treatment of premature ejaculation
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Premature Ejaculation Diagnostic Tool	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	3 months
Secondary	Intravaginal Ejaculatory Latency Time	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	3 months