- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00947323
Simvastatin for Treating Erectile Dysfunction (STED)
September 24, 2010 updated by: Santa Casa de Porto Alegre
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: placebo
|
|
EXPERIMENTAL: Simvastatin
Treatment arm.
|
simvastatin 20 daily for six months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Penile erection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (ACTUAL)
July 1, 2008
Study Completion (ACTUAL)
December 1, 2008
Study Registration Dates
First Submitted
July 27, 2009
First Submitted That Met QC Criteria
July 27, 2009
First Posted (ESTIMATE)
July 28, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 27, 2010
Last Update Submitted That Met QC Criteria
September 24, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Sexual Dysfunctions, Psychological
- Sexual Dysfunction, Physiological
- Vascular Diseases
- Erectile Dysfunction
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
Other Study ID Numbers
- STED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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