Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03879746
Study type Interventional
Source Assiut University
Contact Asmaa Farrag
Phone 201128359948
Email asmaafarrag14@gmail.com
Status Not yet recruiting
Phase Phase 3
Start date April 2019
Completion date May 2020

See also
  Status Clinical Trial Phase
Completed NCT02232425 - IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE) Phase 2
Completed NCT01439984 - Trial of PED-1 in Male Patients With Premature Ejaculation Phase 3
Completed NCT01184105 - A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation Phase 1
Completed NCT01203202 - Phase 2 Trial of PED-1 and PED-2 in Male Patients With Premature Ejaculation Phase 2
Completed NCT03942367 - Evaluation of the Safety and Effectiveness of the vPatch Device N/A
Recruiting NCT06425211 - Effectiveness of Pelvic Floor Therapy for the Management of Erectile Dysfunction and Premature Ejaculation. N/A
Completed NCT02939495 - The Efficacy and Safety of Dapoxetine/Sildenafil Combination Therapy Phase 4
Completed NCT02572037 - Research and Clinical Value of New Classification for Premature Ejaculation: Multi-Center Research
Recruiting NCT02581826 - Safety and Efficacy of Silodosin in the Treatment of Premature Ejaculation Phase 2
Terminated NCT00983736 - Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation Phase 3
Completed NCT00556478 - Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation Phase 2/Phase 3
Completed NCT00549211 - A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296. Phase 1
Not yet recruiting NCT05556083 - Sildenafil Added Effect in Dapoxetine Non-responding Mono-symptomatic Premature Ejaculation (PE) Phase 2
Completed NCT03304808 - Efficacy of a New Behavioral Treatment for Premature Ejaculation Using a Masturbation Aid Device: Star-Stop 3.0 N/A
Completed NCT00861484 - Proof of Mechanism in ELT Phase 1
Completed NCT02984592 - Effect of Exercise on Premature Ejaculation N/A
Recruiting NCT02571101 - A Phase 2 Study of On-demand Therapy With Clomipramine and Sildenafil Combination in Premature Ejaculation Phase 2
Completed NCT03174470 - Safety Demonstration of Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle N/A
Completed NCT02794454 - A Study to Evaluate Efficacy of Investigational Product HeezOn Ultra -1/ HeezOn Ultra-2 on Male Sexual Health N/A
Completed NCT02297152 - A New Treatment for Premature Ejaculation? N/A