Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Condition(s) targeted: Erectile Dysfunction; Metabolic Syndrome

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: IIEF-EF Domain score at week 8 or LOCF compared with baseline

Secondary outcome:

Percentage of subjects achieving "back to normal" erectile function

All diary questions other than SEP 2 and 3 that concern erectile function that were assessed over the entire treatment period

Percentage of patients who can stay on the initially provided dosage of vardenafil (10 mg PRN)

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Male.

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

- 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

- 29 Additional Exclusion Criteria

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Berlin 12107, Germany; Not yet recruiting

Berlin 14197, Germany; Not yet recruiting

Hamburg 20354, Germany; Not yet recruiting

Regensburg, Bayern 93055, Germany; Recruiting

Cham, Bayern 93413, Germany; Not yet recruiting

Frankfurt, Hessen 60385, Germany; Not yet recruiting

Marburg, Hessen 35039, Germany; Recruiting

Stuhr, Niedersachsen 28816, Germany; Recruiting

Muelheim, Nordrhein-Westfalen 45468, Germany; Recruiting

Grevenbroich, Nordrhein-Westfalen 41515, Germany; Not yet recruiting

Wuppertal, Nordrhein-Westfalen 42103, Germany; Not yet recruiting

Leverkusen, Nordrhein-Westfalen 51373, Germany; Not yet recruiting

Trier, Rheinland-Pfalz 54290, Germany; Not yet recruiting

Koblenz, Rheinland-Pfalz 56068, Germany; Recruiting

Dierdorf, Rheinland-Pfalz 56269, Germany; Not yet recruiting

Homburg, Saarland 66424, Germany; Not yet recruiting

Leipzig, Sachsen 04109, Germany; Recruiting

Dresden, Sachsen 01307, Germany; Not yet recruiting

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Starting date: November 2008
Ending date: August 2009
Last updated: January 13, 2009