Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors
NCT ID: NCT00382161
Last Updated: 2009-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
20 participants
INTERVENTIONAL
2006-10-31
2007-12-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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Fluvastatin-sodium
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Novartis
INDUSTRY
University Hospital, Saarland
OTHER
Principal Investigators
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Magnus Baumhäkel, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of the Saarland
Michael Böhm, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of the Saarland
Martin Gerber, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of the Saarland
Michael Stöckle, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of the Saarland
Locations
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University Hospital of the Saarland
Homburg, Saarland, Germany
Countries
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References
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Diagnosis and treatment of early melanoma. NIH Consensus Development Conference. January 27-29, 1992. Consens Statement. 1992 Jan 27-29;10(1):1-25.
Kinsey AC, Pomeroy WR, Martin CE. Sexual behavior in the human male. 1948. Am J Public Health. 2003 Jun;93(6):894-8. doi: 10.2105/ajph.93.6.894. No abstract available.
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. doi: 10.1016/s0140-6736(85)92023-9.
Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
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. doi: 10.1038/sj.ijir.3900622.
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. doi: 10.1161/01.hyp.29.1.8.
Wei M, Macera CA, Davis DR, Hornung CA, Nankin HR, Blair SN. Total cholesterol and high density lipoprotein cholesterol as important predictors of erectile dysfunction. Am J Epidemiol. 1994 Nov 15;140(10):930-7. doi: 10.1093/oxfordjournals.aje.a117181.
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. doi: 10.1038/83258.
Buyukafsar 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. doi: 10.1016/s0014-2999(03)01905-8.
Wassmann S, Ribaudo N, Faul A, Laufs U, Bohm 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. doi: 10.1016/j.amjcard.2003.09.018.
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. doi: 10.2337/diabetes.52.9.2396.
Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena 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. doi: 10.1038/sj.ijir.3900472.
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. doi: 10.1016/S0022-5347(05)64071-2.
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. doi: 10.1046/j.1365-2265.2003.01764.x.
Laufs U, Wassmann S, Hilgers S, Ribaudo N, Bohm 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. doi: 10.1016/s0002-9149(01)02095-1. No abstract available.
Other Identifiers
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EudraCT-No.:2006-000284-28
Identifier Type: -
Identifier Source: secondary_id
48/05
Identifier Type: -
Identifier Source: org_study_id
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