check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11382

ClinicalTrials.gov Identifier:

NCT00665054

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY38-9456, 5/10/20mg, vs.placebo in Erectile Dysfunction

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - 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.
  • - 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).

Trial summary

Enrollment Goal
160
Trial Dates
August 2004 - August 2005
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Dokuz Eylul UniversitesiIzmir, 35340, Turkey
Completed
Cukurova Universitesi Tip Fakultesi HastanesiAdana, 01330, Turkey
Completed
Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, 34098, Turkey
Completed
Marmara University Medical FacultyIstanbul, 34662, Turkey
Completed
19 Mayis Univ. Tip Fak.Samsun, 55139, Turkey
Completed
Akdeniz Univ. Medical FacultyAntalya, 07003, Turkey
Completed
Gazi Univ. Medical FacultyAnkara, 06500, Turkey
Completed
Hacettepe Univ. Medical FacultyAnkara, 06100, Turkey

Primary Outcome

  • LOCF improved compared to baseline GAQ results at the end of the study
    date_rangeTime Frame:
    baseline versus visit 2 visit 5 or premature termination visit
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • IIEF scores
    date_rangeTime Frame:
    visits 3, 4 and 5
    enhanced_encryption
    Safety Issue:
    no
  • OF, SD, IS scores in IIEF Questionnaire
    date_rangeTime Frame:
    visits 2, 3, 4, 5 or at premature termination visit
    enhanced_encryption
    Safety Issue:
    no
  • Scores of all individual questions on IIEF questionnaire
    date_rangeTime Frame:
    visits 2, 3, 4, 5 or at premature termination visit
    enhanced_encryption
    Safety Issue:
    no
  • Subject's diary response
    date_rangeTime Frame:
    baseline and after randomization per visit period
    enhanced_encryption
    Safety Issue:
    no
  • SSES-E scores
    date_rangeTime Frame:
    visits 2 and 5 or premature termination visit
    enhanced_encryption
    Safety Issue:
    no
  • Summary score from the responses to SSES-E
    date_rangeTime Frame:
    visits 2 and 5 or premature termination visit
    enhanced_encryption
    Safety Issue:
    no
  • Response scores and summary score from the responses to the SF-36
    date_rangeTime Frame:
    visits 2 and 5 or premature termination visit
    enhanced_encryption
    Safety Issue:
    no

Trial design

Multi-centre, randomized, double-blind, parallel, placebo-controlled clinical study to assess the efficacy and tolerability of vardenafil and its influence on self-esteem and self confidence in subjects with erectile dysfunction.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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