Erectile dysfunction is one the common problems of sexual function in men with more prevalence in diabetic men. In our study that is a randomized controlled clinical trial (RCT), 100 men aged 40 to 70 years with diabetes mellitus who suffered from moderate to severe erectile dysfunction were studied in two groups (A and B) with “random fixed block” method. In group A, patients were undergoing with 10 mg tadalafil every other day and 5 mg folic acid daily. In group B, as a control, cases were undergoing with 10 mg tadalafil every other day and placebo. The data were recorded before and after treatment with the IIEF questionnaire and then compared between 2 groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009054582N3
Registration date:2010-10-14, 1389/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-10-14, 1389/07/22
Registrant information
Name
Ali Hamidi Madani
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 5259
Email address
hamidimadani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center of Guilan University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of efficacy of folic acid plus tadalafil in treatment of erectile dysfunction in men with diabetes mellitus type II
Public title
Efficacy of folic acid in treatment of erectile dysfunction in men with diabetes mellitus type II
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- moderate to server Erectile Dysfunction at least 3 months (IIEF < 17). 2- Diabetes mellitus type II. 3- No history of folic acid in last 3 months. Exclusion criteria: 1- Erectile dysfunction with known psychological origin. 2- Cord injury. 3- Patients who are under treatment with folic acid. 4- Contraindication of consumption of 5-phosphodiestrase inhibitors for example history of anaphylactic reaction. 5- Hypertension. 6- Antihypertensive and antilibido drugs consumption. 7- Hyperthyroidism.
Age
From 40 years old to 70 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Assisstant of Guilan University of Medical Sciences
Street address
The Research Assisstant of Guilan University of Medical Sciences
City
Rasht
Postal code
Approval date
2010-08-07, 1389/05/16
Ethics committee reference number
3073
Health conditions studied
1
Description of health condition studied
Erectile Dysfunction
ICD-10 code
N40-N51
ICD-10 code description
Diseases of male genital organs
Primary outcomes
1
Description
Improvement of rectile function
Timepoint
3 months
Method of measurement
IIEF questionaire (International Index of Erectile Function)
Secondary outcomes
empty
Intervention groups
1
Description
Placebo tablet, once daily for 3 months
Category
Placebo
2
Description
Acid folic tablet (5 mg), once daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Clinic of Razi Hospital
Full name of responsible person
Dr. Ahmad Asadollahzadeh
Street address
Razi Hospital
City
Rasht
2
Recruitment center
Name of recruitment center
Dr. Ali Hamidi Madani's Clinic
Full name of responsible person
Dr. Ali Hamidi Madani
Street address
Dr. Ali Hamidi Madani's Clinic
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Siavash Falahatkar, Manager of Urology Research Center
Street address
Urology Research Center, Razi Hospital
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center
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
Urology Research Center
Full name of responsible person
Dr. Ahmad Asadollahzadeh
Position
Coworker/Resident of Urology
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
asad2418@yahoo.com ; urc1384@yahoo.com
Web page address
www.urc.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Ali Hamidi Madani
Position
Assisstant Prof.
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
a42hamidi2000@yahoo.com ; urc1384@yahoo.com
Web page address
www.urc.ir
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Urology Research Center secreter/ Bachlor
Other areas of specialty/work
Street address
Urology Research Cente, Razi Hospital
City
Rasht
Postal code
4144895655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
samaneh_815@yahoo.com ; urc1384@yahoo.com
Web page address
www.urc.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)