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
  Purpose

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 Intervention Phase
Erectile Dysfunction
Vascular Disease Detected
C Reactive Protein
Drug: Simvastatin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Santa Casa de Porto Alegre:

Primary Outcome Measures:
  • Penile erection [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: January 2006
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: Placebo
Experimental: Simvastatin
Treatment arm.
Drug: Simvastatin
simvastatin 20 daily for six months.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Eduardo Touguinha Mastalir, Santa Casa de Porto Alegre
ClinicalTrials.gov Identifier: NCT00947323     History of Changes
Other Study ID Numbers: STED
Study First Received: July 27, 2009
Last Updated: September 24, 2010
Health Authority: Brazil: National Committee of Ethics in Research

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

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

ClinicalTrials.gov processed this record on October 20, 2014