Clinical trial NCT00738400: Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
Official title: Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erectile Dysfunction
Metabolic Syndrome
Keywords: Vardenafil
Erectile Dysfunction
Double-blind study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-08-20
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)


Eligibility criteria: Inclusion Criteria:

* Stable heterosexual relationship
* History of erectile dysfunction for at least 6 months
* IIEF- EF Domain entry score (at Visit 2): \>21 points
* Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
* Subjects motivated for erectile dysfunction treatment
* Documented, dated, written informed consent

Exclusion Criteria:

* Any underlying cardiovascular condition
* History of myocardial infarction
* Uncontrolled atrial fibrillation
* Resting hypotension
* Postural hypotension within 6 months of Visit 1
* History of congenital QT prolongation
* Bleeding disorder
* History of prostatectomy because of prostate cancer
* Hereditary degenerative retinal disorders
* History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
* 29 Additional Exclusion Criteria

Primary outcomes:
measure: Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)
timeFrame: baseline and up to 8 weeks or LOCF
measure: Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8
timeFrame: Baseline and 8 weeks
measure: Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)
timeFrame: up to 8 weeks or LOCF
measure: Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8
timeFrame: Baseline and 8 weeks
measure: Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8
timeFrame: Baseline and 8 weeks
measure: Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))
timeFrame: week 4 and week 8
Other outcomes:
Locations:
city: Cham
country: Germany
state: Bayern
city: Regensburg
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Stuhr
country: Germany
state: Niedersachsen
city: Bonn
country: Germany
state: Nordrhein-Westfalen
city: Grevenbroich
country: Germany
state: Nordrhein-Westfalen
city: Leverkusen
country: Germany
state: Nordrhein-Westfalen
city: Mülheim
country: Germany
state: Nordrhein-Westfalen
city: Wuppertal
country: Germany
state: Nordrhein-Westfalen
city: Dierdorf
country: Germany
state: Rheinland-Pfalz
city: Koblenz
country: Germany
state: Rheinland-Pfalz
city: Trier
country: Germany
state: Rheinland-Pfalz
city: Homburg
country: Germany
state: Saarland
city: Dresden
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Schneider T, Gleissner J, Merfort F, Hermanns M, Beneke M, Ulbrich E. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. J Sex Med. 2011 Oct;8(10):2904-11. doi: 10.1111/j.1743-6109.2011.02383.x. Epub 2011 Jul 19.