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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00665054

Enrollment

160

Registered

2008-04-23

Start date

2004-08-31

Completion date

2005-08-31

Last updated

2014-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Vardenafil, Erectile dysfunction, SSES-E (sexual self-efficacy scale - erectile function)

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

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity

DRUGPlacebo

Matching placebo tablets orally prior to sexual activity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

Healthy volunteers

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
IIEF scores	visits 3, 4 and 5
Summary score from the responses to SSES-E	visits 2 and 5 or premature termination visit
Response scores and summary score from the responses to the SF-36	visits 2 and 5 or premature termination visit
SSES-E scores	visits 2 and 5 or premature termination visit

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026