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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909233
• Other study ID #: 13930
• Secondary ID: LV0701JP
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: December 12, 2014
• Start date: August 2007
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1221
• Est. completion date: December 2011
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of patients with LEVITRA treatment		After 6 months	No
Secondary	LEVITRA treatment improved the patient's erection		After 6 months	No
Secondary	LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse		After 6 months	No
Secondary	Reporting a second successful intercourse within 24 hours of dosing		After 6 months	No
Secondary	Patients prefer LEVITRA over last Erectile Dysfunction treatment		After 6 months	No
Secondary	Tolerability of patients with LEVITRA treatment		After 6 months	Yes

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