Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 25, 2008
Last updated: December 15, 2014
Last verified: December 2014

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)

Condition Intervention Phase
Erectile Dysfunction
Drug: Vardenafil (Levitra, BAY38-9456)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Assessment Question [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Other diary responses [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 348
Study Start Date: March 2003
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Vardenafil (Levitra, BAY38-9456)
Vardenafil 10 mg orally on demand prior to intercourse
Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo


Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age: 20 years and older- Males with erectile dysfunction
  • Stable heterosexual relationship Exclusion Criteria:
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00668135

Hong Kong
Hong Kong, Hong Kong
Jakarta, Indonesia, 10430
Petlaing Jaya, Salangor, Malaysia, 47500
Kuching, Sarawak, Malaysia
Kuala Lumpur, Malaysia, 51200
Kuala Lumpur, Malaysia
Manila, Philippines
Manila, Philippines, 150
Singapore, Singapore, 119074
Singapore, Singapore, 169608
Singapore, Singapore, 529889
Bangkok, Thailand
Bangkok, Thailand, 10700
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT00668135     History of Changes
Other Study ID Numbers: 10657
Study First Received: April 25, 2008
Last Updated: December 15, 2014
Health Authority: Malaysia: Ministry of Health

Keywords provided by Bayer:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents processed this record on October 02, 2015