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Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

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ClinicalTrials.gov Identifier: NCT03879746
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa Farrag, 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.

Condition or disease Intervention/treatment Phase
Premature Ejaculation Drug: Tamsulosin Drug: Paroxetine Hydrochloride Other: placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Tamsulosin on Premature Ejaculation Compared With Paroxetine Hydrochloride
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Active Comparator: tamsulosin group
the first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg
Drug: Tamsulosin
drug will be used in treatment of premature ejaculation

Active Comparator: paroxetine group
the second group will include 40 patients treated with daily administration of paroxetine 20 mg
Drug: Paroxetine Hydrochloride
drug will be used in treatment of premature ejaculation

Active Comparator: combined group
the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg
Drug: Tamsulosin
drug will be used in treatment of premature ejaculation

Drug: Paroxetine Hydrochloride
drug will be used in treatment of premature ejaculation

Placebo Comparator: placrbo group
the fourth group will include 40 patients will be given placebo
Other: placebo
tablets without active substance will be given to patients suffering from premature ejaculation




Primary Outcome Measures :
  1. Premature Ejaculation Diagnostic Tool [ Time Frame: 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 :
  1. Intravaginal Ejaculatory Latency Time [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879746


Contacts
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Contact: Asmaa Farrag 201128359948 ext 00+20 asmaafarrag14@gmail.com

Sponsors and Collaborators
Assiut University

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Responsible Party: Asmaa Farrag, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03879746     History of Changes
Other Study ID Numbers: premature ejaculation
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Premature Ejaculation
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Paroxetine
Tamsulosin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Urological Agents