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Simvastatin for Treating Erectile Dysfunction (STED)

Primary Purpose

Erectile Dysfunction, Vascular Disease Detected, C Reactive Protein

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Simvastatin
Placebo
Sponsored by
Santa Casa de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring simvastatin, endothelial dysfunction, erectile dysfunction

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    placebo

    Simvastatin

    Arm Description

    Treatment arm.

    Outcomes

    Primary Outcome Measures

    Penile erection

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2009
    Last Updated
    September 24, 2010
    Sponsor
    Santa Casa de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00947323
    Brief Title
    Simvastatin for Treating Erectile Dysfunction
    Acronym
    STED
    Official Title
    The Effect of Simvastatin in the Penile Erection: a Randomized, Double-blind Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    December 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Santa Casa de Porto Alegre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Erectile Dysfunction, Vascular Disease Detected, C Reactive Protein
    Keywords
    simvastatin, endothelial dysfunction, erectile dysfunction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Simvastatin
    Arm Type
    Experimental
    Arm Description
    Treatment arm.
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin
    Intervention Description
    simvastatin 20 daily for six months.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Penile erection

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Simvastatin for Treating Erectile Dysfunction

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