Impotence Clinical Trial
Official title:
Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction
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.
Status | Withdrawn |
Enrollment | 20 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of the Saarland | Homburg | Saarland |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Saarland | Novartis |
Germany,
Aversa A, Isidori AM, Spera G, Lenzi A, Fabbri A. Androgens improve cavernous vasodilation and response to sildenafil in patients with erectile dysfunction. Clin Endocrinol (Oxf). 2003 May;58(5):632-8. — View Citation
Braun M, Wassmer G, Klotz T, Reifenrath B, Mathers M, Engelmann U. Epidemiology of erectile dysfunction: results of the 'Cologne Male Survey'. Int J Impot Res. 2000 Dec;12(6):305-11. — View Citation
Büyükafsar K, Un I. Effects of the Rho-kinase inhibitors, Y-27632 and fasudil, on the corpus cavernosum from diabetic mice. Eur J Pharmacol. 2003 Jul 11;472(3):235-8. — View Citation
Chitaley K, Wingard CJ, Clinton Webb R, Branam H, Stopper VS, Lewis RW, Mills TM. Antagonism of Rho-kinase stimulates rat penile erection via a nitric oxide-independent pathway. Nat Med. 2001 Jan;7(1):119-22. — View Citation
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Grimm RH Jr, Grandits GA, Prineas RJ, McDonald RH, Lewis CE, Flack JM, Yunis C, Svendsen K, Liebson PR, Elmer PJ. Long-term effects on sexual function of five antihypertensive drugs and nutritional hygienic treatment in hypertensive men and women. Treatment of Mild Hypertension Study (TOMHS). Hypertension. 1997 Jan;29(1 Pt 1):8-14. — View Citation
Impotence. NIH Consens Statement. 1992 Dec 7-9;10(4):1-33. Review. — View Citation
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Laufs U, Wassmann S, Hilgers S, Ribaudo N, Böhm M, Nickenig G. Rapid effects on vascular function after initiation and withdrawal of atorvastatin in healthy, normocholesterolemic men. Am J Cardiol. 2001 Dec 1;88(11):1306-7. — View Citation
Nangle MR, Cotter MA, Cameron NE. Effects of rosuvastatin on nitric oxide-dependent function in aorta and corpus cavernosum of diabetic mice: relationship to cholesterol biosynthesis pathway inhibition and lipid lowering. Diabetes. 2003 Sep;52(9):2396-402. — View Citation
Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Peña BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. — View Citation
Speel TG, van Langen H, Wijkstra H, Meuleman EJ. Penile duplex pharmaco-ultrasonography revisited: revalidation of the parameters of the cavernous arterial response. J Urol. 2003 Jan;169(1):216-20. — View Citation
Virag R, Bouilly P, Frydman D. Is impotence an arterial disorder? A study of arterial risk factors in 440 impotent men. Lancet. 1985 Jan 26;1(8422):181-4. — View Citation
Wassmann S, Ribaudo N, Faul A, Laufs U, Böhm M, Nickenig G. Effect of atorvastatin 80 mg on endothelial cell function (forearm blood flow) in patients with pretreatment serum low-density lipoprotein cholesterol levels <130 mg/dl. Am J Cardiol. 2004 Jan 1;93(1):84-8. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment. | |||
Secondary | Erectile function assessed with the IIEF-5 score (international index of erectile function) after 8 weeks of treatment. | |||
Secondary | Erectile function assessed with the KEED score (cologne questionnaire of erectile function) after 8 weeks of treatment. |
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