Simvastatin for Treating Erectile Dysfunction (STED)

This study has been completed.

Sponsor:

Information provided by:

Santa Casa de Porto Alegre

ClinicalTrials.gov Identifier:

NCT00947323

First received: July 27, 2009

Last updated: September 24, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 27, 2009
Last Updated Date	September 24, 2010
Start Date ^ICMJE	January 2006
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 27, 2009)	Penile erection [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00947323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Simvastatin for Treating Erectile Dysfunction
Official Title ^ICMJE	The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial
Brief Summary	This is a randomized clinical trial, double-blind, placebo controlled, to verify if simvastatin can improve erectile dysfunction in men with endothelial dysfunction, without any cardiac disease.It is hypothesized that the simvastatin can improve the endothelial function, improving the nitric oxide liberation in corpora cavernosa of the penis, resulting in improvement of erection.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Erectile Dysfunction Vascular Disease Detected C Reactive Protein
Intervention ^ICMJE	Drug: Simvastatin simvastatin 20 daily for six months. Drug: Placebo
Study Arm (s)	Placebo Comparator: placebo Intervention: Drug: Placebo Experimental: Simvastatin Treatment arm. Intervention: Drug: Simvastatin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	41
Completion Date	December 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Erectile dysfunction Elevated C reactive protein Able to adhere the protocol Exclusion Criteria: Diabetes mellitus Cardiac disease Cerebral vascular disease Hypogonadism Any contraindication to simvastatin
Gender	Male
Ages	35 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00947323
Other Study ID Numbers ^ICMJE	STED
Has Data Monitoring Committee	Yes
Responsible Party	Eduardo Touguinha Mastalir, Santa Casa de Porto Alegre
Study Sponsor ^ICMJE	Santa Casa de Porto Alegre
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Santa Casa de Porto Alegre
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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