check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

10695

ClinicalTrials.gov Identifier:

NCT00661115

EudraCT Number:

Not Available

EU CT Number:

Not Available
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Trial purpose

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Key Participants Requirements

Sex

Male

Age

21 Years
  • - Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
    - having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

  • - Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
    - Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
    - Subjects could not be on androgens/anti-androgens or alpha blockers.

Trial summary

Enrollment Goal
173
Trial Dates
May 2003 - February 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Mumbai, 400007, India
Completed
Belagum, 590010, India
Completed
Madurai, 625107, India
Completed
Mumbai, 400022, India
Completed
Bangalore, 560010, India
Completed
Bangalore, 560054, India

Primary Outcome

  • Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15
    date_rangeTime Frame:
    At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Success in penetration and maintenance as recorded in subject diaries
    date_rangeTime Frame:
    At Weeks 4, 8 and 12 (as observed and at LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Scores for questions 3 and 4 of the IIEF
    date_rangeTime Frame:
    At Weeks 4, 8 and 12 (as observed and at LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Other IIEF domain scores
    date_rangeTime Frame:
    At Week 12 (observed and at LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Question (GAQ) responses
    date_rangeTime Frame:
    At Weeks 4, 8 and 12 (as observed and at LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use.
    date_rangeTime Frame:
    At Weeks 4, 8 and 12 (as observed and at LOCF)
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A randomised, double blind, placebo controlled, multi-center, fixed dose, parallel group study to investigate the efficacy and safety of vardenafil (BAY 38-9456) in men 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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