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CompletedNCT00660998Updated Dec 11, 2014

Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes

A Phase 4 interventional study of Levitra (Vardenafil, BAY38-9456) and Placebo in Erectile Dysfunction, sponsored by Bayer. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-11.

Sponsored by Bayer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
318
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction

02

Conditions studied

  • Erectile Dysfunction

Keywords

  • Erectile dysfunction
  • Diabetes mellitus type 1
  • Vardenafil
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 318 is above the median of 72 across 552 interventional 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.

Browse Bayer studies →

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • Diabetes type 1
  • Stable sexual relationship for > 6 month.

Exclusion criteria

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
318 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug: Levitra (Vardenafil, BAY38-9456)

  • Placebo comparator
    Arm 2

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Sexual Encounter Profile Question 2

    Time frame: 12 weeks

  2. Sexual Encounter Profile Question 3

    Time frame: 12 weeks

Secondary outcomes

  1. International Index of Erectile Function - Erectile Function Domain

    Time frame: 12 weeks

  2. Safety and Tolerability

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

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

The record gives a start of Feb 2003 and a completion of Jan 2004. 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
Apr 15, 2008
First posted
Apr 18, 2008
Start
Feb 2003
CompletionActual
Jan 2004
Last update
Dec 11, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
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 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00660998
Lead sponsor
Bayer
First posted
Apr 18, 2008
Start date
Feb 2003
Completion
Jan 2004
Last update
Dec 11, 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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