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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01207947
Enrollment
491
Registered
2010-09-23
Start date
2007-10-31
Completion date
2010-03-31
Last updated
2015-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Vardenafil, Erectile dysfunction, Phosphodiesterase Inhibitors, Combination use with alpha-blockers

Brief 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.

Interventions

Patients under daily life treatment receiving Levitra according to local drug information.

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients \>/= 18 years * Enrollment within 7 days after initiation of combination use of Levitra and alpha-blockers

Design outcomes

Primary

MeasureTime frame
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.unsatisfied2 months
Safety of Levitra treatment, namely incidence of Adverse Events or Adverse Drug Reactions are evaluated2 months

Secondary

MeasureTime frame
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.unsatisfied2 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026