check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

13930

ClinicalTrials.gov Identifier:

NCT00909233

EudraCT Number:

Not Available

EU CT Number:

Not Available
LEVITRA® 20mg Special Drug Use Investigation (long-term)

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - 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.

Trial summary

Enrollment Goal
1221
Trial Dates
August 2007 - December 2011
Phase
N/A
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Japan

Primary Outcome

  • Efficacy of patients with LEVITRA treatment
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • LEVITRA treatment improved the patient's erection
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    No
  • LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Reporting a second successful intercourse within 24 hours of dosing
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Patients prefer LEVITRA over last Erectile Dysfunction treatment
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Tolerability of patients with LEVITRA treatment
    date_rangeTime Frame:
    After 6 months
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

LEVITRA® 20mg Special Drug Use Investigation (long-term)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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