Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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
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Main outcome variables
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Time of Ejaculation
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-06-10, 1397/03/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-22, 1397/04/01
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Expected recruitment end date
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2019-06-22, 1398/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comprative Study of Therapeutic Effect of Two Medicinal Procedures of Sertraline in Premature Ejaculation
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Public title
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Study of Therapeutic Effect of Sertraline in Premature Ejaculation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 65 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-02-25, 1396/12/06
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Ethics committee reference number
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IR.AJAUMS.REC.1396.111
Health conditions studied
1
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Description of health condition studied
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Premature Ejaculation
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ICD-10 code
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F52.4
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ICD-10 code description
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Premature ejaculation
Primary outcomes
1
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Description
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Time of Ejaculation ( From Vaginal Entrance to Ejaculation )
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Timepoint
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The Time of Ejaculation at the Beginning of the Study ( Before the Intervention) and 4 and 8 weeks after the start of Sertraline
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Method of measurement
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Measure the time in seconds by the stopwatch by the patient's wife
Intervention groups
1
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Description
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Intervention group 1: Sertraline will receive 50 mg every 12 hours from Abidi-Tehran Pharmaceutical Company for 8 weeks.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Sertraline will receive 50 mg 4 hours before coitus from Abidebi-Tehran Pharmaceutical Company for 8 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Artesh University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available