A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

Overview

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Full Title of Study: “A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2005

Interventions

  • Drug: Levitra (Vardenafil, BAY38-9456)
    • Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
  • Drug: Placebo
    • Matching Placebo

Arms, Groups and Cohorts

  • Placebo Comparator: Arm 2
  • Experimental: Arm 1

Clinical Trial Outcome Measures

Primary Measures

  • Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign.
    • Time Frame: 16 weeks

Secondary Measures

  • International Index of Erectile Function
    • Time Frame: 16 weeks
  • Treatment Satisfaction Scale
    • Time Frame: 16 weeks
  • Other patient diary based variables
    • Time Frame: 16 weeks
  • Safety and tolerability
    • Time Frame: 16 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance – Heterosexual relationship for more than 6 months – Partner willing to complete the TSS Exclusion Criteria:

  • Primary hypoactive sexual desire – History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months – Nitrate use – Other exclusion criteria apply according to the Summary of Product Characteristics

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

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

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