The objective of this study is to assess the effect of Bupropion on Sexual Dysfunction and Quality Of Life In men with Chronic Kidney Disease. In this double-blind clinical trial study, 40 men with chronic kidney disease who suffering from sexual dysfunction refer to the Zanjan nephrology clinic are recruited. Patients will rule out for anatomical penile dysfunction, history of prostatectomy and history of priapism. also patients with history of seizure, head trauma and organic brain disease will be excluded. For all patients sexual dysfunction standard questionnaire and quality of life questionnaire (WHOQOL- BREF) will be completed. Personal demographics, anthropometric measurements, and drug history will be also taken. Then they are randomly assigned to two twenty-member groups. The first group will take 100 mg of bupropion tablet for 10 weeks, and the second group will take placebo. After 10 weeks, for all the participants the questionnaires will be completed again and results will analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011732012N1
Registration date:2017-02-01, 1395/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-01, 1395/11/13
Registrant information
Name
Leila Dashtaki
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4000
Email address
dashtaki_md@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Zanjan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation The Effect of Bupropion Tablet On Sexual Dysfunction And Quality Of Life In Men With Chronic Kidney Disease
Public title
Efficacy Of Bupropion Tablet On Sexual Dysfunction And Quality Of Life In Men With Chronic Kidney Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: male patients with chronic kidney disease, age between 25-60 years old who have sexual dysfunction from 6 months ago.
Exclusion Criteria: Age older than 60 years; Anatomical penile dysfunction; History of prostatectomy; History of priapism; History of seizure; Head trauma; Organic brain disease; Psychosis; History of alcohol use; Use Monoamino Oxidase inhibitor drugs
Age
From 25 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences Ethics Committee
Street address
Azadi Square
City
Zanjan
Postal code
4515613191
Approval date
2016-07-09, 1395/04/19
Ethics committee reference number
ZUMS.REC.1395.100
Health conditions studied
1
Description of health condition studied
Sexual Dysfunction
ICD-10 code
N52.9
ICD-10 code description
Male Erectile Dysfunction, Unspecified
Primary outcomes
1
Description
Erectile Dysfunction
Timepoint
First Day and 10 Weeks Later
Method of measurement
IIEF-5 Standard Questionnaire
2
Description
Quality Of Life
Timepoint
First Day and 10 Weeks Later
Method of measurement
Quality of Life Questionnaire (WHOQOL-BREF)
Secondary outcomes
empty
Intervention groups
1
Description
20 Patients: Tablet Bupropion 100mg For 10 Weeks
Category
Treatment - Drugs
2
Description
20 Patients: Placebo For 10 Weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology Clinic Of Valiasr Hospital
Full name of responsible person
Dr.Leila Dashtaki
Street address
Valiasr Square
City
Zanjan
2
Recruitment center
Name of recruitment center
Nephrology Clinic Of Shahid Beheshti Hospital
Full name of responsible person
Dr.Leila Dashtaki
Street address
Arq Square
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Zanjan University of Medical Sciences
Full name of responsible person
Dr.Alireza Shoghli
Street address
Azadi Square
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Bahare Hajsalimi
Position
Nephrologist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Square
City
Zanjan
Postal code
4513615788
Phone
+98 24 3342 0459
Fax
Email
bhajsalimi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Seyed Abolfazl Ghoreishi
Position
Associate Professor Of Psychiatry
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Arq Square
City
Zanjan
Postal code
4513815778
Phone
+98 24 3354 4000
Fax
Email
sabgho@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Leila Dashtaki
Position
Psychiatry Resident
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Arq Square
City
Zanjan
Postal code
4513815778
Phone
+98 24 3354 4000
Fax
Email
dashtaki_md@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)