BAY38-9456, 5/10/20mg, Versus Placebo in 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

To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo. Levitra in impotence

Official title: Multi-Centre, Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-Esteem and Self Confidence in Subjects With Erectile Dysfunction.

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

Primary outcome: LOCF improved compared to baseline GAQ results at the end of the study

Secondary outcome:

IIEF scores

OF, SD, IS scores in IIEF Questionnaire

Scores of all individual questions on IIEF questionnaire

Subject's diary response

SSES-E scores

Summary score from the responses to SSES-E

Response scores and summary score from the responses to the SF-36

Detailed description: Purpose of the study is:

- To assess the efficacy and tolerability of vardenafil in male subjects suffering from

erectile dysfunction as compared to placebo

- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects

suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Men with heterosexual relationships aged 18 -64 years suffering from ED for more than

6 months according to the NIH Consensus Statement (i. e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).

- At least 4 attempts at sexual intercourse (according to the question in the subject

diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

- Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease)

that in the investigator's opinion would significantly impair sexual performance.

- Primary hypoactive sexual desire.

- Spinal cord injury

- History of surgical prostatectomy (transurethral interventions not excluded).

- Unstable angina pectoris.

- History of myocardial infarction, stroke or life-threatening arrhythmia within the

prior 6 months.

- Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate

>100 BPM).

Izmir 35340, Turkey

Adana 01330, Turkey

Ankara 06500, Turkey

Istanbul 34-300, Turkey

Istanbul 34662, Turkey

Ankara 06100, Turkey

Samsun 55139, Turkey

Antalya 07003, Turkey

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Starting date: August 2004
Ending date: August 2005
Last updated: April 22, 2008