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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665054
• Other study ID #: 11382
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2008
• Last updated: December 23, 2014
• Start date: August 2004
• Est. completion date: August 2005

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics CommitteeTurkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
• Placebo
Matching placebo tablets orally prior to sexual activity

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	GlaxoSmithKline

Country where clinical trial is conducted

Turkey, 

Outcome

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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