Determining and Comparing the Satisfaction and Effectiveness of Dapoxitin in Patients Before and After Dapoxitin administration
Design
Patients with premature ejaculation referred to the office in a semi-experimental manner in 2019 to 2020 with a sample number of 100 people.
Settings and conduct
This study was performed on patients with premature ejaculation who referred to the office of the urology professors of the faculty of the Islamic Azad University, Shahroudeh Branch.
The semi-experimental form (before and after taking the drug) will be performed in 2019 to 2020
Participants/Inclusion and exclusion criteria
People with the following conditions will enter the study:
1. Have ejaculatory ejaculation
2. Be at least 20 to 40 years old
3. Tendency to take medications regularly and continuously until the end of the treatment period
4. Have a desire to participate and cooperate in this research
5. Have at least once a week close
and in case of the following conditions, they will be excluded from the study:
1. Do not have any contraindications to the use of drugs
2. Have no history of drug and alcohol use continuously
3_ .Disorder of erection, genital urinary tract infection, systemic or neurological disorder, do not have severe mental disorder
4. Do not have a history of IHD, DM, HTN, HLP and severe vascular disorders as proven
Intervention groups
Patients studied for 30 mg dopoxitin tablets are given two hours before intercourse, one-month treatment period and are asked to complete the questionnaires
Main outcome variables
Premature ejaculation time; satisfaction with treatment; side effects of treatment; effectiveness of treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200624047912N1
Registration date:2020-07-07, 1399/04/17
Registration timing:registered_while_recruiting
Last update:2020-07-07, 1399/04/17
Update count:0
Registration date
2020-07-07, 1399/04/17
Registrant information
Name
Saeed Tavakoli nezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 0745
Email address
Saeedtin.tavakolii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of patients' satisfaction with the effectiveness of dopoxetin in premature ejaculation and its complications
Public title
Evaluation of patients' satisfaction with the effectiveness of dopoxetin in premature ejaculation and its complications
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have ejaculatory ejaculation
Be at least 20 to 40 years old
Tendency to take medications regularly and continuously until the end of the treatment period
Have a desire to participate and cooperate in this research 5. Have at least once a week close
Exclusion criteria:
Do not have any contraindications to the use of drugs (sensitivity to SSRI_ alcohol consumption_ calculation of lactose_ history of heart problem_depression) You have become _strength of safety_consumption of tramadol_ _MAOI
Have no history of drug and alcohol use continuously
Disorder of erection, genital urinary tract infection, systemic or neurological disorder, do not have severe mental disorder
Do not have a history of IHD, DM, HTN, HLP and severe vascular disorders as proven
Age
From 20 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University Shahrood Branch
Street address
Central Building, Islamic Azad University, next to the gas station
City
Shahrood
Province
Semnan
Postal code
4318936199
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1397.044
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
Ejaculation time
Timepoint
Before treatment - 10 days after treatment - one month later
Method of measurement
Questionnaires 1, 2 and 3whith Using a timer to minute
2
Description
Drug side effects
Timepoint
10 days after treatment - one month later
Method of measurement
Questionnaires 2 and 3 mention the specified options
3
Description
Satisfaction with treatment
Timepoint
10 days after treatment - one month later
Method of measurement
Questionnaires 2 and 3 mention excellent, good, medium, poor
Secondary outcomes
1
Description
Ejaculation time score
Timepoint
Before treatment - 10 days after treatment - one month later
Method of measurement
Questionnaires 1, 2 and 3 with the option marked to the time score
Intervention groups
1
Description
This study will be performed on patients with premature ejaculation in a semi-experimental manner. Dapoxetine 30 mg oral tablets are given by Kosar Pharmaceutical Company and Complete the questionnaires 10 days later and one month before treatment. Dapoxitin pharmacology is a selective inhibitor of short-term serotonin reuptake inhibitors.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam alanbia hospital
Full name of responsible person
Seyed Vahid Sadr Bolorian
Street address
Khatam Alanbia Hospital, Daneshgah blvd.
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3239 2661
Fax
+98 23 3233 1876
Email
khatam-shahrood.ac@email.com
Web page address
http://khatam.iau-shahrood.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behroz Yahyaei
Street address
Khatam Alanbia Hospital, Daneshgah blvd.
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3236 3433
Fax
+98 23 3233 1876
Email
khatam-shahrood.ac@email.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
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
Seyed Vahid Sadr Bolorian
Position
PHD
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Khatam Alanbia Hospital, Daneshgah blvd.
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3236 3433
Email
saeedtin.tavakolii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Vahid Sadr Bolorian
Position
PHD
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Khatam Alanbia Hospital, Daneshgah blvd.
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 23 3236 3433
Email
saeedtin.tavakolii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Tavakoli Nezhad
Position
intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Khatam Alanbia Hospital, Daneshgah blvd.
City
Shahrood
Province
Semnan
Postal code
3614871151
Phone
+98 935 731 9771
Email
saeedtin.tavakolii@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
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available