Placebo-Controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Condition(s) targeted: Erectile Dysfunction

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

Phase: Phase 4

Status: Completed

Sponsored by: Bayer

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

Study to investigate the efficacy and safety of Vardenafil

Official title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-Dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

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

Primary outcome:

Erectile Function domain of the International Index of Erectile Function

Sexual Encounter Profile Question 2

Sexual Encounter Profile Question 3

Secondary outcome:

Erectile Function domain scores > 26

Sexual Encounter Profile 2

Global Assessment Question

Reliability of insertion

Reliability of maintenance

Other subject diary based variables

Safety and tolerability

Detailed description: Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. This also called impotence is a significant issue for men and their partners with increasing prevalence and with more men seeking treatment. Non-response to sildenafil has been reported by men and presents a challenge to those seeking treatment. This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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

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Starting date: October 2002
Ending date: January 2004
Last updated: April 4, 2008