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

NCT00382161 | Withdrawn Phase 3 DMC

• 2 other identifiers: 48/05EudraCT-No.:2006-000284-28
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Impotence

Keywords

impotence; erectile dysfunction; cardiovascular risk factor; statin

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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.

Interventions

Fluvastatin-sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Saarland: lead
• Novartis: collaborator

Study Sites (1)

University Hospital of the Saarland

Homburg, Saarland, 66421, Germany

Location

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MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Fluvastatin

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2006
• First Posted: September 28, 2006
• Study Start: October 1, 2006
• Study Completion: December 1, 2007
• Last Updated: February 13, 2009

Record last verified: 2009-02

Locations

DE (1)