Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00631969

12093

2008-000536-40 (EudraCT Number)

Details and patient eligibility

About

This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.

Enrollment: 362 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males 18 years-of-age or older
• Stable, heterosexual relationship for at least 6 months
• A history of erectile dysfunction (ED) for at least 6 months

Exclusion criteria

• Any underlying cardiovascular condition, including unstable angina pectoris
• History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
• Uncontrolled atrial fibrillation / flutter at screening
• History of surgical prostatectomy for prostate cancer
• Hereditary degenerative retinal disorders
• History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
• Presence of penile anatomical abnormalities
• Subjects who have been confirmed with phenylketonuria (PKU)
• Spinal cord injury
• Resting or postural hypotension or hypertension
• Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
• Use of any treatment for ED within 7 days of Visit 1
• History of congenital QT prolongation
• History of syncope within the last 6 months prior to entry into the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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362 participants in 2 patient groups, including a placebo group

Vardenafil ODT (STAXYN, BAY38-9456)

Experimental group

Description:

Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

Treatment:

Drug: Vardenafil ODT (STAXYN, BAY38-9456)

Placebo

Placebo Comparator group

Description:

Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

Treatment:

Drug: Placebo