Effect of modafinil in the treatment of premature ejaculation
Design
Randomized, double blind, parallel, Clinical trials with control group
Settings and conduct
Patients with premature ejaculation are randomly divided into two groups using envelopes containing colored cards and are treated with 100 mg modafinil or placebo for 4 weeks, 4 to 6 hours before intercourse
Participants/Inclusion and exclusion criteria
Patients with premature ejaculation who signed written informed consent and Currently, are not under further treatments
Intervention groups
The intervention group received moadfinil tablet and the control group received placebo tablet
Main outcome variables
Premature ejaculation profile score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090304001743N15
Registration date:2020-05-01, 1399/02/12
Registration timing:prospective
Last update:2020-05-01, 1399/02/12
Update count:0
Registration date
2020-05-01, 1399/02/12
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 4184
Email address
haghighi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of modafinil in the treatment of premature ejaculation: a randomized, double-blind, placebo-controlled clinical trial
Public title
Influence of modafinil in the treatment of premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premature ejaculation, based on the criteria of the DSM – 5
Married and having at least 6 months continuous sexual intercourse with a sexual partner
Life long premature ejaculation
Signed written informed consent
Exclusion criteria:
Currently under further treatments for premature ejaculation
Erectile dysfunction or other sexual disorders
Other psychiatric disorders such as Major depressive disorder bipolar disorders, anxiety disorders, post-traumatic stress disorders, or personality disorders
Chronic diseases such as diabetes, hypertension, endocrine system disease
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
23 red cards and 23 blue cards are placed in a non-transparent packets, Each person picks up a packet, Each color is considered for a group
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, placebo, which is precisely in the form of a drug product, is administered randomly to the patients and explained to the patients that he or she may receive a drug or placebo. Therefore, the patient and the clinical caregiver are not aware of the type of product.The other person other than the investigator is responsible for the preparation of the drug and placebo boxes and the researcher is not aware of it. The investigator of the outcome is also unaware of the type of product.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmideh Bulvar.Mahdieh street
City
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2020-04-25, 1399/02/06
Ethics committee reference number
IR.UMSHA.REC.1399.081
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
Premature ejaculation profile score
Timepoint
Before the intervention, 4 weeks after the intervention
Method of measurement
Premature ejaculation profile Questionnaire
Secondary outcomes
1
Description
Intravaginal ejaculation latency time
Timepoint
Before the intervention,4 weeks s after intervention
Method of measurement
By a stopwatch
Intervention groups
1
Description
Intervention group: Modafinil tablets 100 mg 4 to 6 hours before intercourse
Category
Treatment - Drugs
2
Description
Control group: placebo tablets 4 to 6 hours before intercourse
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mohammad Haghighi
Street address
Dibaj Street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Ahmadpanah
Street address
fahmideh Bulvar, Mahdieh street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
m1ahmad2000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad haghighi
Position
Professor of Psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital,Dibaj street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
mohammad Haghighi
Position
Professor of psychiatry
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital,Dibaj street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
haghighi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
leila jahangard
Position
professor of psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian hospital,Dibaj Street
City
Hamadan
Province
Hamadan
Postal code
65175
Phone
+98 81 3827 1066
Email
jahangard@umsha.ac.ir
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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