Effects of Testosterone in the treatment of erectile dysfunction in patients with type 2 diabetes mellitus
Design
Clinical trial, Superiority, Single blind, Two-arm parallel group, Per-portocol
Settings and conduct
Type 2 diabetes mellitus Patients with erectile dysfunction who referred to urology clinic of Ghaem or Emam Reza hospitals, affiliated to Mashhad university of medical sciences, were enrolled in this study. The baseline level of testosterone was normal in all participants.
Before the study commencement laboratory parameters including liver function tests, CBC, PSA, and lipid profile were measured for all participants. Patients were excluded if they had any contraindication for testosterone or Tadalafil consumption.
We used closed pockets for allocation concealment.
IIEF-5 questionnaire was completed by blind evaluators at baseline, 3-month and 6-month follow-up. After 3-month the laboratory tests were measured again.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Completing the written informed consent
Presence of Erectile dysfunction
Presence of Type 2 Diabetes Mellitus
Normal Serum Testosterone level
IIEF=<16
Exclusion criteria:
Contraindication for Tadalafil consumption including Heart disease, Hypertension, and Nitrocontin consumption
Contraindication for Tadalafil consumption including liver disorder and prostate cancer
Intervention groups
Intervention group: Administration of 250mg Testosterone at study commencement and the first and second month of the study+standard treatment using 20mg Tadalafil 2-hour before intercourse.
Control group: standard treatment using 20mg Tadalafil 2-hour before intercourse
Main outcome variables
IIEF-5 score
Lipid profile
CBC
PSA
Liver Function test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181106041575N1
Registration date:2019-05-17, 1398/02/27
Registration timing:retrospective
Last update:2019-05-17, 1398/02/27
Update count:0
Registration date
2019-05-17, 1398/02/27
Registrant information
Name
Esmail Tootoonchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 2857
Email address
totonchie951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-04-04, 1398/01/15
Actual recruitment start date
2018-10-23, 1397/08/01
Actual recruitment end date
2019-04-04, 1398/01/15
Trial completion date
2019-04-14, 1398/01/25
Scientific title
Effects of Testosterone Therapy on Erectile Dysfunction in Type 2 Diabetes Mellitus Patients with normal level of Testosterone
Public title
Testosterone Therapy in Type 2 Diabetes Mellitus Patients with Erectile Dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of Erectile dysfunction
Presence of Type 2 Diabetes Mellitus
Normal Serum Testosterone level
IIEF=<16
Exclusion criteria:
Contraindication for Tadalafil consumption including: Heart disease, Hypertension and Nitrocontin consumption
Contraindication for Tadalafil consumption including: liver disorder and prostate cancer
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
66
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
Randomization description
This study used simple randomization. Randomization units consisted of individuals. We used closed pockets for randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
Study participants: patients will be divided into intervention and control groups. control and the intervention group won`t notice the treatment protocols in other group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No. 18, Daneshgah Ave, Mashhad, Iran.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-10-16, 1397/07/24
Ethics committee reference number
ir.mums.medical.rec.1397.352
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
F52.21
ICD-10 code description
Male erectile disorder
Primary outcomes
1
Description
erectile dysfunction according to The International Index of Erectile Function (IIEF-5).
Timepoint
International Index of Erectile Function (IIEF-5) was completed before, 3-month, and 6-month after the intervention
Method of measurement
erectile dysfunction according to The International Index of Erectile Function (IIEF-5).
Secondary outcomes
1
Description
the side-effects of the intervention
Timepoint
before and 3-month after the intervention
Method of measurement
the side-effects of the intervention was measured using laboratory findings including liver function test, complete blood count (CBC), liver function test (LFT), fasting blood sugar and Prostate-specific antigen (PSA).
Intervention groups
1
Description
Intervention group: intramuscular injection of 250 mg testosterone each month for 3 consecutive months in addition of 20mg Tadalafil, 2-hour before each intercourse.
Category
Treatment - Drugs
2
Description
Control group: oral consumption of 20mg Tadalafil, 2-hour before each intercourse.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology clinic of Ghaem hospital
Full name of responsible person
Salman Soltani
Street address
Parastar Ave, Ahmad Abad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91766-99199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac.ir
2
Recruitment center
Name of recruitment center
Urology clinic of Emam Reza hospital
Full name of responsible person
Salman Soltani
Street address
Emam Reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
emamreza@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and technology deputy of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi building, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 2081
Email
TafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and technology deputy of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Esmaeil Totonchi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Parastar Ave, Ahmad Abad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
TOTONCHIE951@MUMS.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Salman Soltani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Emam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
SoltaniS@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Esmaeil Totonchi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Parastar Ave, Ahmad Abad blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
TOTONCHIE951@MUMS.AC.IR
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
these files will be presented upon request: Patients` data after removing their identity, Research protocol, statistical methods used in this study and written informed consent.
When the data will become available and for how long
data will be available 3 months after the article has been published
To whom data/document is available
Any researcher who needs our data to accomplish his research
Under which criteria data/document could be used
The researcher should use these data only in their related research and should mention the reference
From where data/document is obtainable
Researchers should send their request to Dr. Salman Soltani via email. Email:SoltaniS@mums.ac.ir
What processes are involved for a request to access data/document
Researchers should send their request for data that includes their reasons for using the data and their study protocols and aims. The request will be answered during 14 business days