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ImpotencePhase 3NCT00382161

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

A Phase 3 study testing Fluvastatin-sodium in people with Impotence, run by University Hospital, Saarland at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Impotence
What is being tested?
Fluvastatin-sodium
How many people
20 participants
Where
1 siteGermany
Study dates
Oct 2006to Dec 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital of the Saarland

    Homburg, Saarland, 66421

Other trials in Germany

About this study

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.

Read the 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).

Conditions
Impotence
Being tested
Fluvastatin-sodium
Keywords
impotence, erectile dysfunction, cardiovascular risk factor, statin
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluvastatin-sodiumDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

  1. Erectile function assessed with the IIEF-5 score (international index of erectile function) after 8 weeks of treatment.

  2. Erectile function assessed with the KEED score (cologne questionnaire of erectile function) after 8 weeks of treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2006 (estimated)
  2. Study startOct 2006
  3. Study completionDec 2007 (estimated)

Why it stopped: not enough patients meeting inclusion criteria

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00382161
Sponsor's protocol ID
48/05
Other IDs
EudraCT-No.:2006-000284-28
Status last verified
Feb 2009
First submitted
27 Sep 2006
Last updated
13 Feb 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Diagnosis and treatment of early melanoma. NIH Consensus Development Conference. January 27-29, 1992. Consens Statement. 1992 Jan 27-29;10(1):1-25.

    PubMed 1515516

  • 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.

    PubMed 12773346

  • 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.

    PubMed 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. doi: 10.1016/s0022-5347(17)34871-1.

    PubMed 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. doi: 10.1038/sj.ijir.3900622.

    PubMed 11416833

  • 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.

    PubMed 9039073

  • 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.

    PubMed 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. doi: 10.1038/83258.

    PubMed 11135626

  • 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.

    PubMed 12871759

  • 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.

    PubMed 14697473

  • 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.

    PubMed 12941781

  • 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.

    PubMed 10637462

  • 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.

    PubMed 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. doi: 10.1046/j.1365-2265.2003.01764.x.

    PubMed 12699447

  • 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.

    PubMed 11728362

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fluvastatin-sodium in people with Impotence, run by University Hospital, Saarland at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Penile blood flow (peak systolic velocity, resistance index, pulsatility index) after 8 weeks of treatment.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00382161, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2009.

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