BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

Phase 4

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo

• Registration Number: NCT00665054
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-22
• Study First Posted: 2008-04-23
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 160

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Levitra (Vardenafil, BAY38-9456)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
LOCF improved compared to baseline GAQ results at the end of the study	baseline versus visit 2 visit 5 or premature termination visit

Secondary Outcome Measures

Name	Time	Method
Response scores and summary score from the responses to the SF-36	visits 2 and 5 or premature termination visit
IIEF scores	visits 3, 4 and 5
OF, SD, IS scores in IIEF Questionnaire	visits 2, 3, 4, 5 or at premature termination visit
Scores of all individual questions on IIEF questionnaire	visits 2, 3, 4, 5 or at premature termination visit
Subject's diary response	baseline and after randomization per visit period
SSES-E scores	visits 2 and 5 or premature termination visit
Summary score from the responses to SSES-E	visits 2 and 5 or premature termination visit