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Protocol summary
This study is a non-randomized, non-placebo-controlled clinical trial and a comparative study on the therapeutic effect of sertraline therapy every 12 hours and 4 hours before coitus in the treatment of premature ejaculation and dose reduction and therapeutic treatment in patients. One hundred twenty patients (each group of sixty) will be surveyed from July 2017 to July 2018.
This study is a randomized, non-placebo-controlled clinical trial and a comparative study on the therapeutic effect of sertraline therapy every 12 hours and 4 hours before coitus in the treatment of premature ejaculation and dose reduction and therapeutic treatment in patients. One hundred twenty patients (each group of sixty) will be surveyed from July 2017 to July 2018.
This study is a non-randomized, non-placebo-controlled clinical trial and a comparative study on the therapeutic effect of sertraline therapy every 12 hours and 4 hours before coitus in the treatment of premature ejaculation and dose reduction and therapeutic treatment in patients. One hundred twenty patients (each group of sixty) will be surveyed from July 2017 to July 2018.
این مطالعه یک مطالعه کارآزمایی بالینی غیرتصادفی بدون گروه دارونما و مقایسه ای از نظر اثر درمانی دو روش درمانی سرترالین هر دوازده ساعت و چهار ساعت قبل از نزدیکی در درمان انزال زودرس و کاهش دوز و روش درمانی در بیماران می باشد. یک صد و بیست نفر (هرگروه شصت نفر) از تیرماه 1397 تا تیر ماه 1398در این مطالعه مورد بررسی قرار خواهند گرفت
این مطالعه یک مطالعه کارآزمایی بالینی تصادفی بدون گروه دارونما و مقایسه ای از نظر اثر درمانی دو روش درمانی سرترالین هر دوازده ساعت و چهار ساعت قبل از نزدیکی در درمان انزال زودرس و کاهش دوز و روش درمانی در بیماران می باشد. یک صد و بیست نفر (هرگروه شصت نفر) از تیرماه 1397 تا تیر ماه 1398در این مطالعه مورد بررسی قرار خواهند گرفت
این مطالعه یک مطالعه کارآزمایی بالینی غیرتصادفیتصادفی بدون گروه دارونما و مقایسه ای از نظر اثر درمانی دو روش درمانی سرترالین هر دوازده ساعت و چهار ساعت قبل از نزدیکی در درمان انزال زودرس و کاهش دوز و روش درمانی در بیماران می باشد. یک صد و بیست نفر (هرگروه شصت نفر) از تیرماه 1397 تا تیر ماه 1398در این مطالعه مورد بررسی قرار خواهند گرفت
General information
Not randomized
Randomized
nrandrand
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Randomization method in this research is Simple Randomization. Randomization unit was individual and patients randomization method is computerized random numbers. The starting point is completely random ( selecting a number on the table with closed eyes) and the direction of movement in the table is selected to the bottom. The patients are randomly assigned to one of the two study groups using the random numbers table and receive the relevant intervention.
Randomization method in this research is Simple Randomization. Randomization unit was individual and patients randomization method is computerized random numbers. The starting point is completely random ( selecting a number on the table with closed eyes) and the direction of movement in the table is selected to the bottom. The patients are randomly assigned to one of the two study groups using the random numbers table and receive the relevant intervention.
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روش تصادفی سازی در این تحقیق تصادفی سازی ساده میباشد. واحد تصادفی سازی, فردی بوده و ابزار تصادفی سازی بیماران جدول اعداد تصادفی با استفاده از کامپیوتر می باشد.نقطه شروع کاملا تصادفی (انتخاب یک عدد روی جدول با چشم بسته ) و انتخاب جهت حرکت در جدول در جهت پایین انتخاب شد. بیماران به صورت تصادفی با کمک جدول اعداد تصادفی در یکی از دو گروه مطالعه قرار می گیرند و مداخله مربوطه را دریافت می کنند.
روش تصادفی سازی در این تحقیق تصادفی سازی ساده میباشد. واحد تصادفی سازی, فردی بوده و ابزار تصادفی سازی بیماران جدول اعداد تصادفی با استفاده از کامپیوتر می باشد.نقطه شروع کاملا تصادفی (انتخاب یک عدد روی جدول با چشم بسته ) و انتخاب جهت حرکت در جدول در جهت پایین انتخاب شد. بیماران به صورت تصادفی با کمک جدول اعداد تصادفی در یکی از دو گروه مطالعه قرار می گیرند و مداخله مربوطه را دریافت می کنند.
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Protocol summary
Study aim
Comprative study of therapeutic effect of two medicinal procedures of Sertraline 4 hours before coitus and each 12 hours in premature ejaculation , and declining symptoms of drug in patients through decreasing dosage and therapeutic procedure in patients
Design
This study is a randomized, non-placebo-controlled clinical trial and a comparative study on the therapeutic effect of sertraline therapy every 12 hours and 4 hours before coitus in the treatment of premature ejaculation and dose reduction and therapeutic treatment in patients. One hundred twenty patients (each group of sixty) will be surveyed from July 2017 to July 2018.
Settings and conduct
The location of the study is in the Imam Reza hospital of Tehran affiliated to the Army University of Medical Science. patients are evaluated by an urologist and, if approved, have an early ejaculation according to the definition of DMS-4 enrollred In this study,after obtaining consent Written
Participants/Inclusion and exclusion criteria
Inclusion Criteria : Male with Premature Ejaculation؛ Possible at least Once Coitus on Week and Age between 20 to 65 years
Exclusion Criteria : Norologic Disorder؛ Psycologic Disorder؛ Age Less than 20 and Over 65 Years؛ Urinary and Genital Infection and History of Pelvic Surgery
Intervention groups
In the first group, it is prescribed 50 mg of sertraline each 12 hours daily and the second group is prescribed 50 mg four hours before coitus. Finally, the time the ejaculation before treatment (mean time in at least three coitus) and at the end of the fourth and eighth weeks after treatment are accurately measured and recorded by the patient's wife with a stopwatch . Patients are advised to record time from vaginal entrance to ejaculation
Main outcome variables
Time of Ejaculation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180401039167N1
Registration date:2018-06-10, 1397/03/20
Registration timing:prospective
Last update:2019-01-29, 1397/11/09
Update count:1
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Bijan Rezakhaniha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 6431
Email address
reza.bijan1345@ajaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprative Study of Therapeutic Effect of Two Medicinal Procedures of Sertraline in Premature Ejaculation
Public title
Study of Therapeutic Effect of Sertraline in Premature Ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male with Premature Ejaculation
Possible at least Once Coitus a Week
Age between 20 to 65 years
Exclusion criteria:
Norologic Disorder
Psycologic Disorder
Age Less than 20 and Over 65 Years
Urinary and Genital Infection
History of Pelvic Surgery
Age
From 20 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method in this research is Simple Randomization. Randomization unit was individual and patients randomization method is computerized random numbers. The starting point is completely random ( selecting a number on the table with closed eyes) and the direction of movement in the table is selected to the bottom. The patients are randomly assigned to one of the two study groups using the random numbers table and receive the relevant intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Aja University of Medical Sciences
Street address
Emam Reza Hospital, Sarhang etemadzadeh ve, Fatemi Ave
City
Tehran
Province
Tehran
Postal code
IR.26.110791
Approval date
2018-02-25, 1396/12/06
Ethics committee reference number
IR.AJAUMS.REC.1396.111
Health conditions studied
1
Description of health condition studied
Premature Ejaculation
ICD-10 code
F52.4
ICD-10 code description
Premature ejaculation
Primary outcomes
1
Description
Time of Ejaculation ( From Vaginal Entrance to Ejaculation )
Timepoint
The Time of Ejaculation at the Beginning of the Study ( Before the Intervention) and 4 and 8 weeks after the start of Sertraline
Method of measurement
Measure the time in seconds by the stopwatch by the patient's wife
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Sertraline will receive 50 mg every 12 hours from Abidi-Tehran Pharmaceutical Company for 8 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Sertraline will receive 50 mg 4 hours before coitus from Abidebi-Tehran Pharmaceutical Company for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Bijan Rezakhaniha
Street address
Emam Reza hospital,Sarhang Etemadzadeh Ave, Fatemi St
City
Tehran
Province
Tehran
Postal code
IR.26.110791
Phone
+98 21 2274 6600
Email
reza.bijan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Arsia Taghva
Street address
Aja University of Medical Sciences, Sarhang Etemadzadeh Ave, Fatemi St
City
Tehran
Province
Tehran
Postal code
IR26.110791
Phone
+98 21 8609 5072
Email
reza.bijan1345@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bijan Rezakhaniha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Sarhang Etemadzadeh st, Fatemi st
City
Tehran
Province
Tehran
Postal code
IR26.110791
Phone
+98 21 2264 6431
Fax
Email
reza.bijan1345@ajaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bijan Rezakhaniha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Sarhang Etemadzadeh st, Fatemi st
City
Tehran
Province
Tehran
Postal code
IR26.110791
Phone
+98 21 2264 6431
Fax
Email
reza.bijan1345@ajaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Bijan Rezakhaniha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Reza Hospital, Sarhang Etemadzadeh st, Fatemi st
City
Tehran
Province
Tehran
Postal code
IR26.110791
Phone
+98 21 2264 6431
Fax
Email
reza.bijan1345@ajaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available