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.
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00159848 -
Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra
|
Phase 4 | |
| Completed |
NCT00654082 -
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction
|
Phase 4 | |
| Completed |
NCT00882934 -
The Management of Erectile Dysfunction With Placebo Only
|
N/A | |
| Recruiting |
NCT00297544 -
Effect of Sildenafil on Endothelial Function
|
N/A | |
| Completed |
NCT00245596 -
Evaluation of the Index of Sexual Life Questionnaire
|
Phase 4 | |
| Completed |
NCT00249730 -
Titration Study to Evaluate Efficacy and Satisfaction of Viagra in Men With Erectile Function.
|
Phase 4 | |
| Completed |
NCT00547183 -
Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection
|
Phase 3 | |
| Completed |
NCT00422578 -
Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction
|
Phase 4 | |
| Completed |
NCT00547092 -
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection
|
Phase 4 | |
| Completed |
NCT00547508 -
To Determine How Different Doses of Tadalafil Work on Getting and Keeping an Erection 26 or 36 Hours After Taking
|
Phase 3 | |
| Completed |
NCT00422734 -
Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life
|
Phase 3 | |
| Completed |
NCT00245258 -
Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction
|
Phase 4 | |
| Completed |
NCT00301262 -
Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
|
Phase 4 | |
| Completed |
NCT00147628 -
Assessment Of Sildenafil On Erectile Function And Intercourse Satisfaction And To Validate A New Subject Questionnaire
|
Phase 4 | |
| Completed |
NCT00547287 -
Studying the Preference of Tadalafil to Sildenafil in Men With Problems Getting an Erection Across Nations
|
Phase 3 | |
| Completed |
NCT03830164 -
Pentoxifylline, Atorvastatin, and Vitamin E in Treating Patients With Erectile Dysfunction After Radiation Therapy for Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT00498680 -
Safety and Clinical Effectiveness of 2 Lower Dose Combined PDE5i's vs. Single Maximal Dose PDE5i
|
Phase 4 | |
| Completed |
NCT00150358 -
To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .
|
Phase 4 | |
| Completed |
NCT00547495 -
Study the Safety and Effectiveness of Tadalafil in Men With Problems Getting or Maintaining an Erection When Taken Prior to Desiring an Erection
|
Phase 3 | |
| Completed |
NCT00143221 -
Effectiveness and Safety of Viagra in Men With ED and LUTS Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 4 |