check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

10690

ClinicalTrials.gov Identifier:

NCT00668057

EudraCT Number:

Not Available

EU CT Number:

Not Available
BAY38-9456 (Vardenafil HCL tablet) in ED treatment for China registration.

Trial purpose

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Key Participants Requirements

Sex

Male

Age

22 Years
  • - Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
    - Stable heterosexual relationship
  • - Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
    - Nitrate use
    - Other exclusion criteria apply

Trial summary

Enrollment Goal
624
Trial Dates
December 2002 - September 2003
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Beijing, 100191, China
Completed
Shanghai, 200001, China
Completed
HangZhou, 310003, China
Completed
Beijing, 100034, China
Completed
Beijing, 100044, China
Completed
Beijing, 100853, China
Completed
Shanghai, 200040, China

Primary Outcome

  • Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Global Assessment Questionnaire
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Erectile Function domain score of the International Index of Erectile Function
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients with Erectile Dysfunction
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
6

Additional Information

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