Comparison of paroxetine and dapoxetine in the treatment of premature ejaculation
Design
In this interventional study conducted as a clinical trial, 110 patients with premature ejaculation referring to Azad University hospitals in Tehran in the year 97 were selected and available. And their demographic information is recorded by the data collection form
Settings and conduct
. Then, in the absence of contraindication, patients will receive either one daily dose of 20 mg paroxetine or 30 mg of dapoxetine if necessary, and the therapeutic efficacy includes an increase in the duration of intravenous Ejaculatory Latency Time by 1.5 minutes in two The group is determined and compared, and the complications are studied and compared in patients.
Participants/Inclusion and exclusion criteria
inclusion
Occurrence of intravaginal ejaculatory latency time less than one minute
Not receiving other treatments in the past month
Male
Single sexual partner
Patient consent for the measurement of ejaculation time
No allergy to paroxetine and dapoxetine and other contraindications
Age 19-65
exclusion
Women
No precocious (premature) ejaculation
Azospermia
Men without external genitalia
Occurrence of cryptorchidism in men
Erection inability
Homosexual men
Use of Viagra
Men questioning their gender identity
Men having extramarital sex
Intervention groups
Intervention group 1: Patients receiving paroxetine
Intervention group 2: Patients receiving dapoxetine
Main outcome variables
increase Intravaginal Ejaculatory Latency Time up 1.5 min
General information
Reason for update
Acronym
PE = PREMATURE EJACULATION
IRCT registration information
IRCT registration number:IRCT20180512039618N1
Registration date:2019-04-01, 1398/01/12
Registration timing:prospective
Last update:2019-04-01, 1398/01/12
Update count:0
Registration date
2019-04-01, 1398/01/12
Registrant information
Name
zhra Madadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3660 4854
Email address
z-madadi@alumnus.tums.ac.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2639-12-14, 2018/09/23
Expected recruitment end date
2640-12-14, 2019/09/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Paroxetin Effectiveness Compared to Dupoxitin in Treatment of premature ejaculation Patients
Public title
بررسی ميزان اثربخشی پاروكسيتين در مقايسه با داپوكسيتين در درمان انزال زودرس در بيماران
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Occurrence of intravaginal ejaculatory latency time less than one minute
Not receiving other treatments in the past month
Male
Single sexual partner
Patient consent for the measurement of ejaculation time
No allergy to paroxetine and dapoxetine and other contraindications
Age 19-65
Exclusion criteria:
No precocious (premature) ejaculation
Azospermia
Men without external genitalia
Occurrence of cryptorchidism in men
Erection inability
Homosexual men
Use of Viagra
Men questioning their gender identity
Men having extramarital sex
Age
From 19 years old to 65 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Nothing mentioned
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی ازاد اسلامی
Street address
Shariati street
City
tehran
Province
Tehran
Postal code
1916893813
Approval date
2018-01-30, 1396/11/10
Ethics committee reference number
IR.IAU.TMU.REC.1397.201
Health conditions studied
1
Description of health condition studied
Premature ejaculation
ICD-10 code
F52.4
ICD-10 code description
F52.4
Primary outcomes
1
Description
improve Intravaginal Ejaculatory Latency Time up 1.5 min
Timepoint
Paroxetine: daily for 1 mouth , Dapoxetine: before sex activity
Method of measurement
stop watch
Secondary outcomes
1
Description
travaginal Ejaculatory Latency Time
Timepoint
1 month
Method of measurement
question
Intervention groups
1
Description
Intervention group: men 19-64 years old with premature ejaculation with paroxetine
Category
Treatment - Drugs
2
Description
Intervention group: men 19-64 years old with premature ejaculation with Dapoxetine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali hospital
Full name of responsible person
Hossein Keyhan
Street address
Damavand street
City
Tehran
Province
Tehran
Postal code
11111111111111
Phone
+98 21 3660 4854
Fax
+98 21 3660 4854
Email
sara.hajinajafi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Kyhan
Street address
Damavand street
City
Tehran
Province
Tehran
Postal code
111111111
Phone
+98 21 3660 4854
Fax
+98 21 3660 4854
Email
sara.hajinajafi@yahoo.com
Grant name
Noooooooooo
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
-
Proportion provided by this source
1
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Hoessin Keyhan
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Damavand street
City
Tehran
Province
Tehran
Postal code
1111111
Phone
+98 21 3660 4854
Fax
+98 21 3660 4854
Email
Sara.hajinajafi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Keyhan
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Damavand street
City
Tehran
Province
Tehran
Postal code
11111
Phone
+98 21 3660 4854
Fax
+98 21 3660 4854
Email
sara.hajinajafi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hossein Keyhan
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Damavand street
City
Tehran
Province
Tehran
Postal code
11111
Phone
+98 21 3660 4854
Fax
+98 21 3660 4854
Email
sara.hajinajafi@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
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