Influence of Lisdexamfetamine Mesilate (Vyas) in the treatment of premature ejaculation: A double-blind randomized clinical trial study
Design
A randomized clinical trial with parallel control group, double blind; Phase 2-3, on 46 patients; randomization is performed by using block randomization.
Settings and conduct
This study is performed in Farshchian Hospital in Hamadan. The intervention group is given a 30 mg capsule of Lisdexamfetamine Mesilate (Vyas) and the control group is given a placebo pill in the same form, and it is recommended that they take it at noon on a day when they are likely to be close to that day.Participants are asked to have intercourse at least twice a week for a month, and during the intervention do not use other methods such as topical creams or stop-motion techniques to increase ejaculation time and do not use condoms.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age older and equal to 18 years
Married and having at least 6 months of continuous sexual intercourse with a sexual partner
Clinical diagnosis of PE based on PEDT questionnaire
exclusion criteria: Taking drugs for sexual disorders during the study
Having depression or other major psychiatric disorders during the study
Intervention groups
Intervention group : Patients receiving of 30 mg capsule Lisdexamfetamine Mesilate (Vyas)
Control group: placebo group that is not distinguishable from the main drug.
Main outcome variables
increase Intra vaginal Ejaculatory Latency Time .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N10
Registration date:2021-02-08, 1399/11/20
Registration timing:prospective
Last update:2021-02-08, 1399/11/20
Update count:0
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-05-23, 1400/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of Lisdexamfetamine Mesilate (Vyas) in the treatment of premature ejaculation: A double-blind randomized clinical trial study
Public title
Influence of Lisdexamfetamine Mesilate (Vyas) in the treatment of premature ejaculation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age older and equal to 18 yearse
Married and having at least 6 months of continuous sexual intercourse with a sexual partner
Clinical diagnosis of premature ejaculation (PE) based on premature ejaculation diagnosis test( PEDT)
Exclusion criteria:
Taking drugs for sexual disorders during the study2
Having depression or other major psychiatric disorders during the study
Age
From 18 years old
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
More than 1 sample in each individual
Number of samples in each individual:
23
23 people are assigned to each group
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the examining physician will not be aware of the patient's type of drug treatment, so the study will be performed in a double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-01-16, 1399/10/27
Ethics committee reference number
IR.UMSHA.REC.1399.870
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
After every intercourse
Method of measurement
By the timer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 mg capsule of Lisdexamfetamine Mesilate (Vyas)
Category
Treatment - Drugs
2
Description
Control group: Placebo tablets
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mohammad Haghighi
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadam
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
haghighi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center for behavioral disorders and substance abuse, Hamadan university of medical sciences
Full name of responsible person
Dr.Mohammad Ahmadpanah
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
haghighi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research center for behavioral disorders and substance abuse, Hamadan 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
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
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 Haghigh
Position
Professor of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
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
Mohammad Haghighi
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
0098 81182851015
Email
haghighi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information"
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available