Einfluss einer Behandlung mit dem HMG-CoA Reduktasehemmer Fluvastatin auf die Erektionsfähigkeit bei Patienten mit kardiovaskulären Risikofaktoren und erektiler Dysfunktion - FluvaED
- Conditions
- erectile dysfunction due to vascular impairment
- Registration Number
- EUCTR2006-000284-28-DE
- Lead Sponsor
- niversitätsklinikum des Saarlandes
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
erectile dysfunction due to vascular impairment (peak flow of penile artery <30cm/s)
two or more cardiovascular risk factors (even orally treated diabetes in patients with HbA1c <7%)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
impaired liver function
acute cardiovascular event
current treatment with a statin
insuline dependent diabetes mellitus or orally treated diabetes mellitus with HbA1c >=7%
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Improvement of penile blood flow and erectile function in patients treated with fluvastatin;Secondary Objective: ;Primary end point(s): penile blood flow<br>erectile function (questionnaire)
- Secondary Outcome Measures
Name Time Method