Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00909233
Enrollment
1221
Registered
2009-05-27
Start date
2007-08-31
Completion date
2011-12-31
Last updated
2014-12-15

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

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunction,, Phosphodiesterase Inhibitors

Brief 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.

Interventions

DRUGVardenafil, (Levitra, BAY38-9456)

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

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Efficacy of patients with LEVITRA treatmentAfter 6 months

Secondary

MeasureTime frame
LEVITRA treatment improved the patient's erectionAfter 6 months
LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourseAfter 6 months
Reporting a second successful intercourse within 24 hours of dosingAfter 6 months
Patients prefer LEVITRA over last Erectile Dysfunction treatmentAfter 6 months
Tolerability of patients with LEVITRA treatmentAfter 6 months

Countries

Japan

Outcome results

None listed

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