Erectile Dysfunction Clinical Trial
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.
Verified date | December 2014 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics CommitteeTurkey: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 160 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 64 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer | GlaxoSmithKline |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LOCF improved compared to baseline GAQ results at the end of the study | baseline versus visit 2 visit 5 or premature termination visit | No | |
Secondary | IIEF scores | visits 3, 4 and 5 | No | |
Secondary | OF, SD, IS scores in IIEF Questionnaire | visits 2, 3, 4, 5 or at premature termination visit | No | |
Secondary | Scores of all individual questions on IIEF questionnaire | visits 2, 3, 4, 5 or at premature termination visit | No | |
Secondary | Subject's diary response | baseline and after randomization per visit period | No | |
Secondary | SSES-E scores | visits 2 and 5 or premature termination visit | No | |
Secondary | Summary score from the responses to SSES-E | visits 2 and 5 or premature termination visit | No | |
Secondary | Response scores and summary score from the responses to the SF-36 | visits 2 and 5 or premature termination visit | No |
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