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CompletedNCT00909233Updated Dec 15, 2014

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

An observational study in Erectile Dysfunction, sponsored by Bayer. Completed at 1 site in Japan. Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-12-15.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,221
Ages
18 Years to 64 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • Erectile dysfunction,
  • Phosphodiesterase Inhibitors
03

In context

Erectile Dysfunction

698 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's enrollment of 1,221 is above the median of 135 across 120 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.

Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Primary care clinic

Eligibility criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,221 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Vardenafil, (Levitra, BAY38-9456)

Interventions

06

What researchers measure

Primary outcomes

  1. Efficacy of patients with LEVITRA treatment

    Time frame: After 6 months

Secondary outcomes

  1. LEVITRA treatment improved the patient's erection

    Time frame: After 6 months

  2. LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse

    Time frame: After 6 months

  3. Reporting a second successful intercourse within 24 hours of dosing

    Time frame: After 6 months

  4. Patients prefer LEVITRA over last Erectile Dysfunction treatment

    Time frame: After 6 months

  5. Tolerability of patients with LEVITRA treatment

    Time frame: After 6 months

07

Study locations

1 site
  • Many Locations, Japan
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2007, a primary completion of Mar 2010 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 8, 2009
First posted
May 27, 2009
Start
Aug 2007
Primary completionActual
Mar 2010
CompletionActual
Dec 2011
Last update
Dec 15, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 15, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00909233
Lead sponsor
Bayer
First posted
May 27, 2009
Start date
Aug 2007
Primary completion
Mar 2010
Completion
Dec 2011
Last update
Dec 15, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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