NCT00947323

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2006

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

2.5 years

First QC Date

July 27, 2009

Last Update Submit

September 24, 2010

Conditions

Erectile DysfunctionVascular Disease DetectedC Reactive Protein

Keywords

simvastatinendothelial dysfunctionerectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • Penile erection

Study Arms (2)

placebo

PLACEBO COMPARATOR
Drug: Placebo

Simvastatin

EXPERIMENTAL

Treatment arm.

Drug: Simvastatin

Interventions

SimvastatinDRUG

simvastatin 20 daily for six months.

Simvastatin
PlaceboDRUG
placebo

Eligibility Criteria

Age35 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Erectile dysfunction
  • Elevated C reactive protein
  • Able to adhere the protocol

You may not qualify if:

  • Diabetes mellitus
  • Cardiac disease
  • Cerebral vascular disease
  • Hypogonadism
  • Any contraindication to simvastatin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 27, 2009

First Posted

July 28, 2009

Study Start

January 1, 2006

Primary Completion

July 1, 2008

Study Completion

December 1, 2008

Last Updated

September 27, 2010

Record last verified: 2010-09