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TerminatedNCT01215409Updated May 19, 2014

Real Life Safety and Efficacy of Vardenafil

An observational study in Erectile Dysfunction, sponsored by Bayer. Terminated at 1 site in Taiwan. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-19.

Sponsored by Bayer · Observational

Why this study was terminated
Slow recruitment
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
372
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Erectile Dysfunction

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Keywords

  • Levitra
  • Erectile dysfunction
  • Taiwan
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In context

Erectile Dysfunction

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

This study's enrollment of 372 is above the median of 130 across 115 observational studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

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

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Who can participate

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

Study population

Primary care clinics

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

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the product information (Package Insert).
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
372 participants (actual)

Groups and cohorts

  • Group 1

    Drug: Vardenafil (Levitra, BAY38-9456)

Interventions

  • DrugVardenafil (Levitra, BAY38-9456)

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

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What researchers measure

Primary outcomes

  1. General assessment of patients concerning efficacy and tolerability of vardenafil treatment

    Time frame: 2 months

Secondary outcomes

  1. Time to first intercourse after intake of vardenafil

    Time frame: 2 months

  2. Percentage of successful second intercourse within 24 hours

    Time frame: 2 months

  3. Percentage of participants who are willing to continue treatment

    Time frame: 2 months

  4. Number of participants with adverse events

    Time frame: 2 months

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Study locations

1 site
  • Many Locations, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01215409
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Oct 6, 2010
Start date
Feb 2008
Primary completion
Nov 2008
Completion
Nov 2008
Last update
May 19, 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 terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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