Comparison of the Effectiveness of Dapoxitine, Paroxetine, Combination therapy of Dapoxetine/Tadalafil and Combination therapy of Paraoxytine/Tadalafil in treatment of patients with premature ejaculation
Comparison of the Effectiveness of Dapoxetine, Paroxetine, Combination therapy of Dapoxetine/Tadalafil and Combination therapy of Paraoxytine/Tadalafil in treatment of patients with premature ejaculation
Design
controlled clinical trial, Factorial Groups, Not Blinded, Randomized
Settings and conduct
In This Study, Patients will be randomly assigned to study groups using color cards in four colors for each drug group. The study will Consist of 4 Groups and each Group Will Consist of 30 patients. This Study Will Take Place in Emam Reza Hospital Ardabil Branch.
Participants/Inclusion and exclusion criteria
Married men aged between 20 to 50 years old with at least one intercourse in week, less than 2 minutes IELT, without underlying disease, erectile dysfunction and not treated with any psychiatric medication
Intervention groups
First Group Paroxetine 20 mg Tablets (Tehran Shimi Company) Orally, One Tablet Daily for One Month
Second Group Dapoxetine 30 mg Tablet (Shafa Pharmaceutical Company) orally, One Tablet One hour before Sex for One Month
Third Group Paroxetine 20 mg Tablets (Tehran Shimi Company) Orally, One Tablet Daily for One Month along with Tadalafil 10 mg Tablets (Roozdaru Pharmaceutical Company) Orally One Hour Before Sex For One Month
Fourth Group Dapoxetine 30 mg Tablet (Shafa Pharmaceutical Company) orally, One Tablet One hour before Sex for One Month along with Tadalafil 10 mg Tablets (Roozdaru Pharmaceutical Company) Orally One Hour Before Sex For One Month
Main outcome variables
cured Premature Ejaculation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190528043747N1
Registration date:2019-11-08, 1398/08/17
Registration timing:registered_while_recruiting
Last update:2019-11-08, 1398/08/17
Update count:0
Registration date
2019-11-08, 1398/08/17
Registrant information
Name
Nima Soluki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 1698
Email address
nima.soluki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-29, 1398/06/07
Expected recruitment end date
2019-11-28, 1398/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Dapoxitine, Paroxetine, Combination therapy of Dapoxetine/Tadalafil and Combination therapy of Paraoxytine/Tadalafil in treatment of patients with premature ejaculation
Public title
Effect of Dapoxitine, Paroxetine, Combination therapy of Dapoxetine/Tadalafil and Combination therapy of Paraoxytine/Tadalafil in premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married men aged between 20 to 50 years
IELT less than 2 minutes
Having at least 1 sexual intercourse in a week
Exclusion criteria:
Having underlying disease including diabetes, hypertension, heart disease, thyroid disease, sexually transmitted disease, and psychiatric disease
Treated with any psychiatric medication
Erectile dysfunction
Age
From 20 years old to 50 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
In This Study, Patients will be randomly assigned to study groups using color cards in four colors for each drug group. The study will Consist of 4 Groups and each Group Will Consist of 30 patients.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Deputy of Research and Technology, North side of Ardebil University of Medical Sciences, Daneshgah Square
City
َArdabil
Province
Ardabil
Postal code
۵۶۱۸۹۸۵۹۹۱
Approval date
2019-08-29, 1398/06/07
Ethics committee reference number
IR.ARUMS.REC.1398.315
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
cured Premature Ejaculation
Timepoint
Evaluation of Premature Ejaculation, Two and Four Weeks after Treatment
Method of measurement
Improved or not Improved Intravaginal Ejaculation Latency Time (Two Minutes) measured by the individual
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Paroxetine 20 mg Tablets (Tehran Shimi Company) Orally, One Tablet Daily for One Month
Category
Treatment - Drugs
2
Description
Intervention group: Dapoxetine 30 mg Tablet (Shafa Pharmaceutical Company) orally, One Tablet One hour before Sex for One Month
Category
Treatment - Drugs
3
Description
Intervention group: Paroxetine 20 mg Tablets (Tehran Shimi Company) Orally, One Tablet Daily for One Month along with Tadalafil 10 mg Tablets (Roozdaru Pharmaceutical Company) Orally One Hour Before Sex For One Month
Category
Treatment - Drugs
4
Description
Intervention group: Dapoxetine 30 mg Tablet (Shafa Pharmaceutical Company) orally, One Tablet One hour before Sex for One Month along with Tadalafil 10 mg Tablets (Roozdaru Pharmaceutical Company) Orally One Hour Before Sex For One Month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Bahram Hafezifar
Street address
Next to Islamic Azad University, Basij Square
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3373 3081
Email
e-reza@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahab Bohlooli
Street address
Ardabil Univercity of Medical Science, Daneshgah Blvd
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3352 2391
Email
s.bohlooli@pharmacy.arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Ali Hosseinkhani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Next to Islamic Azad University, Basij Square
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3373 3081
Email
drhosseinkhani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Ali Hosseinkhani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Next to Islamic Azad University, Basij Square
City
Ardabil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3373 3081
Email
drhosseinkhani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Nima Soluki
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Urology
Street address
No. 5, Nastaran Building, Malek Ashtar Sreet
City
Ardebil
Province
Ardabil
Postal code
4155797315
Phone
+98 45 3352 1698
Fax
Email
nima.soluki@gmail.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