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

This study has been withdrawn prior to enrollment.
(not enough patients meeting inclusion criteria)
Sponsor:
Collaborator:
Novartis
Information provided by:
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00382161
First received: September 27, 2006
Last updated: February 12, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention Phase
Impotence
Drug: Fluvastatin-sodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction

Resource links provided by NLM:


Further study details as provided by University Hospital, Saarland:

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.

Estimated Enrollment: 20
Study Start Date: October 2006
Estimated Study Completion Date: December 2007
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382161

Locations
Germany
University Hospital of the Saarland
Homburg, Saarland, Germany, 66421
Sponsors and Collaborators
University Hospital, Saarland
Novartis
Investigators
Principal Investigator: Magnus Baumhäkel, MD University Hospital of the Saarland
Principal Investigator: Michael Böhm, MD University Hospital of the Saarland
Principal Investigator: Martin Gerber, MD University Hospital of the Saarland
Principal Investigator: Michael Stöckle, MD University Hospital of the Saarland
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00382161     History of Changes
Other Study ID Numbers: 48/05, EudraCT-No.:2006-000284-28
Study First Received: September 27, 2006
Last Updated: February 12, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:
impotence
erectile dysfunction
cardiovascular risk factor
statin

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

ClinicalTrials.gov processed this record on July 22, 2014