To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction

Condition(s) targeted: Erectile Dysfunction

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

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

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

A total of 173 subjects were randomized in 6 centers (vardenafil: 129 subjects; placebo: 44 subjects). All 173 randomized subjects were analyzed for safety. Of these, 162 subjects (94%) were included in the ITT sample (vardenafil: 123 subjects; placebo: 39 subjects) and 149 subjects (86%) were included in the PP sample (vardenafil: 115 subjects; placebo: 34 subjects). The PP sample was only used to analyze the primary efficacy variable (EF domain score).

Official title: A Randomized, Double Blind, Placebo Controlled, Multi-Center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction

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

Primary outcome: Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15

Secondary outcome:

Success in penetration and maintenance as recorded in subject diaries

Scores for questions 3 and 4 of the IIEF

Other IIEF domain scores

Global Assessment Question (GAQ) responses

Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use.

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Men 21 years or above

- ED for more than 6 months

- normal libido

- stable heterosexual relationship of at least 6 months

- having at least a 50% failure rate of sexual intercourse attempts during the run-in

phase

Exclusion Criteria:

- Subjects with penile abnormalities,

- hypogonadism

- history of unstable angina pectoris for 6 months or less

- myocardial infarction

- life threatening arrhythmia

- Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.

- Subjects could not be on androgens/anti-androgens or alpha blockers.

Bangalore, Karnataka 560010, India

Belgaum, Karnataka 590010, India

Bangalore, Karnataka 560054, India

Mumbai, Maharashtra 400007, India

Mumbai, Maharashtra 400022, India

Madurai, Tamilnadu 625107, India

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Starting date: May 2003
Ending date: February 2004
Last updated: April 17, 2008