Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00003988

Trial Description

start of 1:1-Block title

Title

Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

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).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00003988
  •   2012/06/18
  •   2006/09/27
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2006-000284-28 
  •   NCT00382161  (ClinicalTrials.gov)
  •   48/05  (University Hospital, Saarland)
  •   EudraCT-No.:2006-000284-28 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Impotence
  •   N48.4 -  Impotence of organic origin
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Fluvastatin-sodium
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   [---]*
  •   [---]*
  •   Treatment
  •   Crossover
  •   III
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- 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.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2006/10/31
  •   20
  •   [---]*
  •   [---]*
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • University Hospital, Saarland
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • University Hospital of the Saarland
    • Magnus Baumhäkel, MD 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • University Hospital of the Saarland
    • Magnus Baumhäkel, MD 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting withdrawn before recruiting started
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   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.; 2857264
  •   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.; 8254833
  •   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.; 11416833
  •   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.; 7977280
  •   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.; 11135626
  •   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.; 12941781
  •   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.; 12478139
  •   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.; 12699447
  •   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.; 9039073
  •   Büyükaf┼čar 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.; 12871759
  •   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.; 14697473
  •   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.; 10637462
  •   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.; 11728362
  •   Impotence. NIH Consens Statement. 1992 Dec 7-9;10(4):1-33. Review.; 1307265
  •   Kinsey AC, Pomeroy W, Martin CE. Sexual behavior in the human man. 1948:218-262
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   6
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.