check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

10657

ClinicalTrials.gov Identifier:

NCT00668135

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of Vardenafil in patients with erectile dysfunction in Asia

Trial purpose

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

Key Participants Requirements

Sex

Male

Age

20 - 65 Years
  • - Age: 20 years and older- Males with erectile dysfunction
    - Stable heterosexual relationship
  • - Primary hypoactive sexual desire
    - History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months- Nitrate use
    - Other exclusion criteria apply according to the Summary of Product Characteristics

Trial summary

Enrollment Goal
348
Trial Dates
March 2003 - April 2004
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Manila Doctors HospitalManila, Philippines
Completed
National University HospitalSingapore, 119074, Singapore
Completed
Normah Medical Specialist CentreKuching, Malaysia
Completed
Singapore General HospitalSingapore, 169608, Singapore
Completed
Siriraj Hospital, MahidolBangkok, 10700, Thailand
Completed
Changi General HospitalSingapore, 529889, Singapore
Completed
Kwong Wah HospitalHong Kong, Hong Kong
Completed
Cipto Mangunkusumo HospitalJakarta, 10430, Indonesia
Completed
Megah Medical Specialist GroupPetlaing Jaya, 47500, Malaysia
Completed
Chulalongkorn University HospitalBangkok, Thailand
Completed
Cardinal Santos Medical CentreManila, 150, Philippines
Completed
Ramathibodhi HospitalBangkok, Thailand
Completed
University of MalayaKuala Lumpur, Malaysia
Completed
Damai Service HospitalKuala Lumpur, 51200, Malaysia

Primary Outcome

  • International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Global Assessment Question
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Other diary responses
    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

Randomised, double blind, placebo controlled, parallel group, multi-centre, multinational study to evaluate the efficacy and tolerability of Vardenafil (BAY 38-9456) in treatment of male erectile dysfunction in Asia
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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