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Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

Primary Purpose

Premature Ejaculation

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tamsulosin
Paroxetine Hydrochloride
placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Ejaculation

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    tamsulosin group

    paroxetine group

    combined group

    placrbo group

    Arm Description

    the first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg

    the second group will include 40 patients treated with daily administration of paroxetine 20 mg

    the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg

    the fourth group will include 40 patients will be given placebo

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    March 8, 2019
    Last Updated
    March 14, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03879746
    Brief Title
    Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride
    Official Title
    Effect of Tamsulosin on Premature Ejaculation Compared With Paroxetine Hydrochloride
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2019 (Anticipated)
    Primary Completion Date
    April 2020 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Premature Ejaculation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tamsulosin group
    Arm Type
    Active Comparator
    Arm Description
    the first group will include 40 patients treated with daily administration of tamsulosin 0.4 mg
    Arm Title
    paroxetine group
    Arm Type
    Active Comparator
    Arm Description
    the second group will include 40 patients treated with daily administration of paroxetine 20 mg
    Arm Title
    combined group
    Arm Type
    Active Comparator
    Arm Description
    the third group will include 40 patients treated with daily administration of tamsulosin 0.4 mg and paroxetine 20 mg
    Arm Title
    placrbo group
    Arm Type
    Placebo Comparator
    Arm Description
    the fourth group will include 40 patients will be given placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Tamsulosin
    Intervention Description
    drug will be used in treatment of premature ejaculation
    Intervention Type
    Drug
    Intervention Name(s)
    Paroxetine Hydrochloride
    Intervention Description
    drug will be used in treatment of premature ejaculation
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    tablets without active substance will be given to patients suffering from premature ejaculation
    Primary Outcome Measure Information:
    Title
    Premature Ejaculation Diagnostic Tool
    Description
    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
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Intravaginal Ejaculatory Latency Time
    Description
    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
    Time Frame
    3 months

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asmaa Farrag
    Phone
    201128359948
    Ext
    00+20
    Email
    asmaafarrag14@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Effect of Tamsulosin on PE Compared With Paroxetine Hydrochloride

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