Real Life Safety and Efficacy of Vardenafil

Vardenafil in Routine Treatment of Erectile Dysfunction

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01215409

Enrollment

372

Registered

2010-10-06

Start date

2008-02-29

Completion date

2008-11-30

Last updated

2014-05-19

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

Conditions

Erectile Dysfunction

Keywords

Levitra, Erectile dysfunction, Taiwan

Brief summary

In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.

Interventions

DRUGVardenafil (Levitra, BAY38-9456)

5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Any adult patient (\>/=18 years) with erectile dysfunction treated with LEVITRA®. * Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
General assessment of patients concerning efficacy and tolerability of vardenafil treatment	2 months

Secondary

Measure	Time frame
Time to first intercourse after intake of vardenafil	2 months
Percentage of successful second intercourse within 24 hours	2 months
Percentage of participants who are willing to continue treatment	2 months
Number of participants with adverse events	2 months

Countries

Taiwan

Outcome results

None listed

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