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
About this trial
This is an interventional treatment trial for Premature Ejaculation
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.
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
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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