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Effect of Testosterone on Pulmonary Function in Male with Chronic Obstructive Pulmonary Disease

Protocol summary

Study aim
Determine the Effect of Testosterone on Pulmonary Function and Hormonal Responses in Patients with Chronic Obstructive Pulmonary Disease
Design
clinical trial, Randomised, double blinded with a parallel group design of 80 patients
Settings and conduct
A Double Blind Study Will be Performed on All Patients Under 80 years Old with COPD in Amir Al-Momenin Hospital in Arak. Blind Study Includes Participants, Principal Researcher, Clinical Care and Statistical Analyst. Before Starting the Study, the Patients are Divided in to Three Groups: Mild, Moderate and Severe for BPH, Based on I-PSS Score of the American Urology Society.The Mild Group will be Included in the Study After a PSA Test and Ultrasound for Rule Out of prostate cancer. Subsequently, Testosterone and SHBG Test, PFT test, 6min-walk, O2saturation, CAT Score and BMI were be Performed in All Patients. Every 2 weeks, Testosterone Enanthate will be Injected for 16 Weeks to the Test Group and will be Given placebo to the Control Group and the Results will be Reviewed.
Participants/Inclusion and exclusion criteria
After Completing the Informed Consent Form, 80 men less than 80 Years old with COPD were Randomly Assigned into two Groups of 40 Testosterone and Placebo. Patients should not have Exacerbation Attacks at least 4 weeks Before Starting Treatment, Congestive Heart Disease, Severe Uncontrol Hypertension, Venous Thrombosis, History of Thromboembolism, History of Coagulation Disorders, Polycythemia and Prostate Cancer.
Intervention groups
The Intervention will be Performed with 100 mg Testosterone Enanthate Which will be Injected every 2 Weeks for 16 Weeks. For the Control Group, a Drug Solvent, Which is Generally a Basic Substance in all Drugs (Nacl) and Harmless, will be Used in the Same Vials for the Placebo.
Main outcome variables
Changes in hormonal tests, PFT, 6min-walk, Improvement in O2saturation, CAT score, and Changes in BMI

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180805040708N1
Registration date: 2018-08-28, 1397/06/06
Registration timing: registered_while_recruiting

Last update: 2018-08-28, 1397/06/06
Update count: 0
Registration date
2018-08-28, 1397/06/06
Registrant information
Name
Somayeh Mortazavi Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7687 1570
Email address
s.mortazavi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Testosterone on Pulmonary Function in Male with Chronic Obstructive Pulmonary Disease
Public title
Effect of Testosterone in COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Male Patients With Chronic Obstructive Pulmonary Disease
Exclusion criteria:
Exacerbation In the Last 4 Weeks Congestive Heart Disease Sever Uncontrol Hypertention Thromboembolic Disease Coagulation Disorders Polycythemia Prostate Cancer History
Age
To 80 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization With Website: Randomization.com
Blinding (investigator's opinion)
Double blinded
Blinding description
The Study is Double Blind , so that the Participants, Principal Researcher, Clinical Care, Data Analyzer are not Aware of Grouping Results.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Amir Al-Momenin Hospital, Sardasht square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.ARAKMU.REC.1396.245

Health conditions studied

1

Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease

Primary outcomes

1

Description
Pulmonary Function test
Timepoint
Performing a pulmonary function test at the beginning of the study before the start of the intervention and 16 weeks after receiving testosterone.
Method of measurement
Spirometery

Secondary outcomes

1

Description
Body mass index
Timepoint
Measurement of Body Mass Index at the beginning of the study before the intervention and 16 weeks after receiving testosterone
Method of measurement
Based on height and weight

2

Description
6 min-walk distance
Timepoint
Measurement of 6 min-walk distance at the beginning of the study before the intervention and 16 weeks after receiving testosteron
Method of measurement
Meter

3

Description
o2 saturation
Timepoint
Measurement of Pulse Oximetry at the Beginning of the Study Before the Intervention and 16 weeks after Receiving Testosteron
Method of measurement
Pulse Oximetry

Intervention groups

1

Description
Intervention group: Testosterone ٍٍEnanthate will be Injected 100 mg every 2 Weeks for 8 Courses
Category
Treatment - Drugs

2

Description
Control group: For the Control Group, a Drug Solvent, Which is Generally a Basic Substance in all Drugs (Nacl) and Harmless, will be Used in the Same Vials for the Placebo.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al Momenin Hospital
Full name of responsible person
Mortazavi Moghadam Somayeh
Street address
Amir Al Momenin Hospital, Sardasht square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
s.mortazavi@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Amir Al-Momenin Hospital, Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Somayeh Mortazavi Moghadam
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Amir Al-Momenin Hospital, Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 21 7687 1570
Fax
Email
s.mortazavi@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Somayeh Mortazavi Moghadam
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Amir Al-Momenin Hospital, Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 21 7687 1570
Fax
Email
s.mortazavi@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Somayeh Mortazavi Moghadam
Position
Internal medicine assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Amir Al-Momenin Hospital, Sardasht Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 21 7687 1570
Fax
Email
s.mortazavi@arakmu.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
.
When the data will become available and for how long
.
To whom data/document is available
.
Under which criteria data/document could be used
.
From where data/document is obtainable
.
What processes are involved for a request to access data/document
.
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