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NCT01207947 Clinical Trial

LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers

Erectile Dysfunction Clinical Trial

Official title:
LEVITRA® Specific Drug Use Investigation. To Investigate the Safety Profile in Combination Use With Alpha-blockers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01207947
Other study ID # 13931
Secondary ID LV0702JP
Status Completed
Phase Phase 4
First received September 20, 2010
Last updated January 19, 2015
Start date October 2007
Est. completion date March 2010

Study information
Verified date January 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Observational

Clinical Trial Summary

Main object is to investigate the safety profile of Levitra in combination use with alpha-blockers in patients with erectile dysfunction used in clinical practice after launch.

In the initial combination date and the first and second observation after initial combination date, number of tablets prescribed, dose of tablets and number of tablets taken until follow-up visit will be investigated. The efficacy and tolerability will be evaluated at 2 months after initial combination date.

Recruitment information / eligibility
Status Completed
Enrollment 491
Est. completion date March 2010
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients >/= 18 years

- Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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 Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied 2 months No
Primary Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated 2 months Yes
Secondary Tolerability of patients with Levitra treatment, namely satisfactory or not is evaluated by inquiring to the enrolled patient according to the following rating scale: 1.very satisfied, 2.satisfied, 3.unsatisfied 2 months Yes
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