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CompletedNCT00665054Updated Dec 25, 2014

BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

A Phase 4 interventional study of Levitra (Vardenafil, BAY38-9456) and Placebo in Erectile Dysfunction, sponsored by Bayer. Completed at 8 sites in Turkey (Türkiye). Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-12-25.

Sponsored by Bayer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Male
01

Study summary

Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • Vardenafil
  • Erectile dysfunction
  • SSES-E (sexual self-efficacy scale - erectile function)
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 160 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.

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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

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 with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
  • At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion criteria

Exclusion Criteria:

  • Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
  • Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).
  • Unstable angina pectoris.
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
  • Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).
05

Study design

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

Study arms

  • Experimental
    Arm 1

    Drug: Levitra (Vardenafil, BAY38-9456)

  • Placebo comparator
    Arm 2

    Drug: Placebo

Interventions

  • DrugLevitra (Vardenafil, BAY38-9456)

    5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity

  • DrugPlacebo

    Matching placebo tablets orally prior to sexual activity

06

What researchers measure

Primary outcomes

  1. LOCF improved compared to baseline GAQ results at the end of the study

    Time frame: baseline versus visit 2 visit 5 or premature termination visit

Secondary outcomes

  1. IIEF scores

    Time frame: visits 3, 4 and 5

  2. OF, SD, IS scores in IIEF Questionnaire

    Time frame: visits 2, 3, 4, 5 or at premature termination visit

  3. Scores of all individual questions on IIEF questionnaire

    Time frame: visits 2, 3, 4, 5 or at premature termination visit

  4. Subject's diary response

    Time frame: baseline and after randomization per visit period

  5. SSES-E scores

    Time frame: visits 2 and 5 or premature termination visit

  6. Summary score from the responses to SSES-E

    Time frame: visits 2 and 5 or premature termination visit

  7. Response scores and summary score from the responses to the SF-36

    Time frame: visits 2 and 5 or premature termination visit

07

Study locations

8 sites
  • Adana, 01330, Turkey (Türkiye)
  • Ankara, 06100, Turkey (Türkiye)
  • Ankara, 06500, Turkey (Türkiye)
  • Antalya, 07003, Turkey (Türkiye)
  • Istanbul, 34098, Turkey (Türkiye)
  • Istanbul, 34662, Turkey (Türkiye)
  • Izmir, 35340, Turkey (Türkiye)
  • Samsun, 55139, Turkey (Türkiye)
08

Timeline

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

The record gives a start of Aug 2004, a primary completion of Aug 2005 and a completion of Aug 2005. 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 18, 2008
First posted
Apr 23, 2008
Start
Aug 2004
Primary completionActual
Aug 2005
CompletionActual
Aug 2005
Last update
Dec 25, 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 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00665054
Lead sponsor
Bayer
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Apr 23, 2008
Start date
Aug 2004
Primary completion
Aug 2005
Completion
Aug 2005
Last update
Dec 25, 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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