Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT00382161
Status:
WITHDRAWN
Last Update Posted:
2009-02-13
First Post:
2006-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Erectile Dysfunction by Fluvastatin in Patients With Cardiovascular Risk Factors
Sponsor:
University Hospital, Saarland
Organization:
Study Overview
Official Title:
Influence of Treatment With the HMG-CoA-Reductase Inhibitor Fluvastatin on Erectile Function in Patients With Cardiovascular Risk-Factors and Erectile Dysfunction
Status:
WITHDRAWN
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
not enough patients meeting inclusion criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EudraCT-No.:2006-000284-28 | None | None | View |