Protocol summary

Study aim
Comparison of the efficacy of Sertraline and Clomipramin in the treatment of pre ejaculation
Design
This study included two intervention groups that were randomly assigned to treatment groups by blocking permutation method. The trial phase is 2-3. In each group, 30 patients will be treated.
Settings and conduct
This clinical trial is double-blind. That is, the evaluator and the patient are not aware of the type of medication they receive. This study will be conducted in the Golestan Hospital Psychiatry Department.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age between 16-60 years, Possibility to have sex twice in a week. Exclusion criteria: Presence of genital ulcer infection, systemic and neurological disorders, presence of severe psychiatric disorders, presence of narcotics and use of drugs.
Intervention groups
Intervention group 1: In the intervention group1, patients will be treated with sertraline 50 mg daily for three months. Then, the time of the LELT of all people (the average time at least three turns) at the start of the study (LELT0), as well as at 4, 9 and 12 weeks after the start of drug use by a person's partner and with a stopwatch, will be carefully measured and recorded. Intervention group 2: In the intervention group2, patients will be treated with Clomipramin 50 mg daily for three months. Then, the time of the LELT of all people (the average time at least three turns) at the start of the study (LELT0), as well as at 4, 9 and 12 weeks after the start of drug use by a person's partner and with a stopwatch, will be carefully measured and recorded.
Main outcome variables
Duration from moment of insertion to the moment of ejaculation,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181117041682N3
Registration date: 2019-04-27, 1398/02/07
Registration timing: registered_while_recruiting

Last update: 2019-04-27, 1398/02/07
Update count: 0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Ahmad Fakhri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3622 4558
Email address
ahmad_fakhri@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of sertraline and columipramine on premature ejaculation
Public title
Comparison the effect of sertraline and columipramine on premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-60 years Possibility to have sex
Exclusion criteria:
The presence of genital ulcer infection Systemic and neurological disorders Severe psychiatric disorders Use of drugs
Age
From 18 years old to 60 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the method of the permutation blocks of size 4, individuals are randomly divided into two groups. Samples will be divided into two experimental and control groups based on permutation blocks (blocks of size 4). It will be listed according to six possible ways (AABB, ABAB, ...) randomly and the arrangement of receiving intervention will be determined accordingly.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medication will be prescribed by the assistants and given to the patients by the nurses at a psychiatric ward. The project executor is not aware of the prescriptions in each group. Also, patients are unaware of their treatment
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی جندی شاپور اهواز
Street address
Golestan Blvd, Ahvaz, Khoozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-22, 1397/09/01
Ethics committee reference number
IR.AJUMS.REC.1397.901

Health conditions studied

1

Description of health condition studied
Premature ejaculatuon
ICD-10 code
F52.4
ICD-10 code description
Premature ejaculation

Primary outcomes

1

Description
Duration from moment of insertion to the moment of ejaculation,
Timepoint
at the start of treatment, 4,9,12 weeks after treatment
Method of measurement
Stopwatch

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group1, patients will be treated with sertraline 50 mg daily for three months. Then, the time of the LELT of all people (the average time at least three turns) at the start of the study (LELT0), as well as at 4, 9 and 12 weeks after the start of drug use by a person's partner and with a stopwatch, will be carefully measured and recorded
Category
Treatment - Drugs

2

Description
Intervention group: In the intervention group2, patients will be treated with Clomipramin 50 mg daily for three months. Then, the time of the LELT of all people (the average time at least three turns) at the start of the study (LELT0), as well as at 4, 9 and 12 weeks after the start of drug use by a person's partner and with a stopwatch, will be carefully measured and recorded
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Psychiatry Clinic, Golestan Hospital
Full name of responsible person
Ahmad Fakhri
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
ahmad_fakhri@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz Junishapur University of Medical Science,Farvardin Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
badavi.m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Ahmad Fakhri
Position
Associate professorدانشیار
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Dr.fakhri@gmil.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Emraee
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Reza.emraee@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Reza Emraee
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3374 3038
Email
Reza.emraee@yahoo.com

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
Not applicable
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
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