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Simvastatin for Treating Erectile Dysfunction (STED)

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ClinicalTrials.gov Identifier: NCT00947323
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : September 27, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Vascular Disease Detected C Reactive Protein Drug: Simvastatin Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial
Study Start Date : January 2006
Primary Completion Date : July 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: placebo Drug: Placebo
Experimental: Simvastatin
Treatment arm.
Drug: Simvastatin
simvastatin 20 daily for six months.


Outcome Measures

Primary Outcome Measures :
  1. Penile erection

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
More Information

Responsible Party: Eduardo Touguinha Mastalir, Santa Casa de Porto Alegre
ClinicalTrials.gov Identifier: NCT00947323     History of Changes
Other Study ID Numbers: STED
First Posted: July 28, 2009    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by Santa Casa de Porto Alegre:
simvastatin
endothelial dysfunction
erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Vascular Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Cardiovascular Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors