Our goal is assessing the effect of Atorvastatin in responding to Sildenafil in those patients with erectile dysfunction and no previous good response to Sildenafil. Inclusion criteria include presence of erectile dysfunction without a proper response to the Sildenafil treatment. Exclusion criteria include Nitrate users; presence of high serum lipids, diabetes mellitus, thyroid disease, mental disorder, liver disease and Renal failure. We study patients who were visited at heart or urology clinics in Moddares Hospital for their erectile dysfunction. Our study is a randomized double-blind placebo controlled trial and we are going to study 152 patients with erectile dysfunction. We will divide patients into two intervention and control groups. Then, patients will be treated with Sildenafil 100mg and Atorvastatin 40 mg before every intercourse in intervention group and Sildenafil 100 mg and placebo in control group. Patients will be assessed by IIEF-5 and GEQ questionnaires, 6 and 12 weeks after the treatment and two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802301267N3
Registration date:2009-08-03, 1388/05/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-08-03, 1388/05/12
Registrant information
Name
Mojgan Borgheie
Name of organization / entity
Urology and Nephrology Research Center (UNRC), Shahid Beheshti University of Mediacal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 7222
Email address
research@unrc.ir
Recruitment status
Recruitment complete
Funding source
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.R. Iran
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the role of Atorvastatin to improve the response to Sildenafil in men with erectile dysfunction without response to Sildenafil alone
Public title
Evaluation of the role of Atorvastatin to improve the response to Sildenafil in men with erectile dysfunction without response to Sildenafil alone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of erectile dysfunction and without a proper response to the Sildenafil treatment,
Exclusion criteria: Receiving nitrate drugs, high serum lipids (LDL>130, Cholestrol >200), Receiving Statin drugs, Acute coronary accidents in the 6 month prior to study, severe and uncontrolled diabetes mellitus, active thyroid disease, mental disorder or depression diagnosed by a psychiatrist, prostate surgery history with the consequent ED, active liver disease, renal failure (cr>2)
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
152
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Urology and Nephrology Research Center ( UNRC), Shahid Beheshti University, M.C.( SBMU), Tehran, I.