Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 27, 2009
September 24, 2010
January 2006
July 2008   (final data collection date for primary outcome measure)
Penile erection [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00947323 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Simvastatin for Treating Erectile Dysfunction
The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Erectile Dysfunction
  • Vascular Disease Detected
  • C Reactive Protein
  • Drug: Simvastatin
    simvastatin 20 daily for six months.
  • Drug: Placebo
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
  • Experimental: Simvastatin
    Treatment arm.
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
December 2008
July 2008   (final data collection date for primary outcome measure)

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
Male
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00947323
STED
Yes
Eduardo Touguinha Mastalir, Santa Casa de Porto Alegre
Santa Casa de Porto Alegre
Not Provided
Not Provided
Santa Casa de Porto Alegre
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP