LEVITRA® 20mg Special Drug Use Investigation (Long-term)

Overview

This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

Full Title of Study: “LEVITRA® 20mg Special Drug Use Investigation (Long-term)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2010

Interventions

  • Drug: Vardenafil, (Levitra, BAY38-9456)
    • Patients under daily life treatment receiving Levitra according to local drug information.

Arms, Groups and Cohorts

  • Group 1

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of patients with LEVITRA treatment
    • Time Frame: After 6 months

Secondary Measures

  • LEVITRA treatment improved the patient’s erection
    • Time Frame: After 6 months
  • LEVITRA improved the patient’s erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse
    • Time Frame: After 6 months
  • Reporting a second successful intercourse within 24 hours of dosing
    • Time Frame: After 6 months
  • Patients prefer LEVITRA over last Erectile Dysfunction treatment
    • Time Frame: After 6 months
  • Tolerability of patients with LEVITRA treatment
    • Time Frame: After 6 months

Participating in This Clinical Trial

Inclusion Criteria

  • This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

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
    • Medical Director, Bayer Yakuhin Ltd
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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