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Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors

Primary Purpose

Impotence

Status
Withdrawn
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Fluvastatin-sodium
Sponsored by
University Hospital, Saarland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impotence focused on measuring impotence, erectile dysfunction, cardiovascular risk factor, statin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • male
  • age > 18 years
  • arteriogenic erectile dysfunction (penile blood flow - peak systolic velocity<30cm/s, diastolic velocity<5cm/s)
  • two or more cardiovascular risk factors (smoking, hypertension, hyperlipoproteinaemia, family history of atherosclerosis, oral treated diabetes mellitus with a HbA1c<7%)
  • stable course of disease without expected changes in medical treatment during the next 3 months
  • written informed consent
  • no statin-treatment so far

Exclusion Criteria:

  • known hypersensitivity or anaphylaxis against a statin
  • active liver disease or unclear increase of transaminases, cholestasis or myopathy
  • acute cardiovascular event (myocardial infarction, stroke, PTCA, vascular surgery) within 3 months before randomization
  • clinical signs of heart failure or reduced left ventricular function
  • current treatment with lipid lowering drugs
  • insulin dependent diabetes mellitus or orally treated diabetes mellitus with a HbA1c-value >6.9%
  • erectile dysfunction due to hormone disorders
  • known malignant tumor
  • known disposition to priapism
  • patients with morphological changes of the penis (i.e. deviation) or penis-prosthesis
  • current treatment with anticoagulants
  • current treatment with immunosuppressive drugs, phenytoin, erythromycin, gemfibrozil or nicotinic acid derivates
  • absence or inability of written informed consent

Sites / Locations

  • University Hospital of the Saarland

Outcomes

Primary Outcome Measures

Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment.

Secondary Outcome Measures

Erectile function assessed with the IIEF-5 score (international index of erectile function) after 8 weeks of treatment.
Erectile function assessed with the KEED score (cologne questionnaire of erectile function) after 8 weeks of treatment.

Full Information

First Posted
September 27, 2006
Last Updated
February 12, 2009
Sponsor
University Hospital, Saarland
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00382161
Brief Title
Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors
Official Title
Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Withdrawn
Why Stopped
not enough patients meeting inclusion criteria
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Saarland
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study is to determine the effect of fluvastatin on penile arterial blood flow and erectile function in patients with arteriogenic ED and cardiovascular risk factors.
Detailed Description
Physiology of erection is mainly dependent on endothelial NO-production with consecutive activation of guanylate-cyclase. Pleiotropic effects of statins are well known regarding the increase of endothelial function. Thus, activation of endothelial NO-synthase could raise the activation of guanylate-cyclase with a consecutive relaxation of smooth muscle cells in the penile arteries and the corpus cavernosum leading to an improvement of erectile function. Therefore, statins are supposed to be effective in the treatment of erectile dysfunction, especially in patients with cardiovascular risk-factors with underlying endothelial dysfunction. The effect of fluvastatin on penile blood-flow and erectile function in patients with arteriogenic erectile dysfunction and cardiovascular risk factors will be determined in a cross-over design. Patients were either treated with fluvastatin-sodium 80mg or placebo for 8 weeks. After a wash-out of 4 weeks, treatment will be switched (placebo / fluvastatin-sodium). Penile blood flow measurement and assessment of erectile function with the IIEF-5-score and the KEED-score will be performed at baseline, after 8 weeks of treatment, after 4 weeks wash-out and after cross-over treatment (8 weeks).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impotence
Keywords
impotence, erectile dysfunction, cardiovascular risk factor, statin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluvastatin-sodium
Primary Outcome Measure Information:
Title
Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment.
Secondary Outcome Measure Information:
Title
Erectile function assessed with the IIEF-5 score (international index of erectile function) after 8 weeks of treatment.
Title
Erectile function assessed with the KEED score (cologne questionnaire of erectile function) after 8 weeks of treatment.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male age > 18 years arteriogenic erectile dysfunction (penile blood flow - peak systolic velocity<30cm/s, diastolic velocity<5cm/s) two or more cardiovascular risk factors (smoking, hypertension, hyperlipoproteinaemia, family history of atherosclerosis, oral treated diabetes mellitus with a HbA1c<7%) stable course of disease without expected changes in medical treatment during the next 3 months written informed consent no statin-treatment so far Exclusion Criteria: known hypersensitivity or anaphylaxis against a statin active liver disease or unclear increase of transaminases, cholestasis or myopathy acute cardiovascular event (myocardial infarction, stroke, PTCA, vascular surgery) within 3 months before randomization clinical signs of heart failure or reduced left ventricular function current treatment with lipid lowering drugs insulin dependent diabetes mellitus or orally treated diabetes mellitus with a HbA1c-value >6.9% erectile dysfunction due to hormone disorders known malignant tumor known disposition to priapism patients with morphological changes of the penis (i.e. deviation) or penis-prosthesis current treatment with anticoagulants current treatment with immunosuppressive drugs, phenytoin, erythromycin, gemfibrozil or nicotinic acid derivates absence or inability of written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Baumhäkel, MD
Organizational Affiliation
University Hospital of the Saarland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Böhm, MD
Organizational Affiliation
University Hospital of the Saarland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Gerber, MD
Organizational Affiliation
University Hospital of the Saarland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Stöckle, MD
Organizational Affiliation
University Hospital of the Saarland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of the Saarland
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

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Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors

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