Simvastatin for Treating Erectile Dysfunction

Erectile Dysfunction Clinical Trial

— STED  

Official title:

The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947323
• Other study ID #: STED
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2009
• Last updated: September 24, 2010
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: September 2010
• Source: Santa Casa de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• C Reactive Protein
• Erectile Dysfunction
• Vascular Disease Detected
• Vascular Diseases

Intervention

Drug:
• Simvastatin
simvastatin 20 daily for six months.
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santa Casa de Porto Alegre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Penile erection			No