Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

Overview

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Full Title of Study: “A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

  • Drug: Levitra (Vardenafil, BAY38-9456)
    • 5mg, 10mg or 20mg taken 8 hours before sexual intercourse
  • Drug: Placebo
    • matching placebo

Arms, Groups and Cohorts

  • Experimental: Arm 1
  • Placebo Comparator: Arm 2

Clinical Trial Outcome Measures

Primary Measures

  • Per-patient success rates based on Sexual Encounter Profile, Question 3
    • Time Frame: 10 weeks

Secondary Measures

  • Per-subject success rates based on Sexual Encounter Profile, Question 2
    • Time Frame: 10 weeks
  • International Index of Erectile Function- Erectile Function domain score
    • Time Frame: 10 weeks
  • Global Assessment Question (GAQ)
    • Time Frame: 10 weeks
  • Safety and tolerability
    • Time Frame: 10 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, – History of unresponsiveness to sildenafil – Stable sexual relationship for > 6 month. Exclusion Criteria:

  • Primary hypoactive sexual desire – History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month – Nitrate therapy.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Collaborator
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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