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

Bayer

Status and phase: Completed; Phase 4

Conditions: Erectile Dysfunction; Metabolic Syndrome

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00738400

13171

ED-METABOLIC (Other Identifier)

2008-002140-41 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 150 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Vardenafil (Levitra, BAY38-9456)

Experimental group

Description:

Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks

Treatment:

Drug: Vardenafil (Levitra, BAY38-9456)

Placebo

Placebo Comparator group

Description:

Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks

Treatment:

Drug: Placebo