Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

Bayer

Status and phase: Completed; Phase 3

Conditions: Erectile Dysfunction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00682019

100493

Details and patient eligibility

About

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Enrollment: 383 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
• History of unresponsiveness to sildenafil
• Stable sexual relationship for > 6 month.

Exclusion criteria

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
• Nitrate therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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383 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo