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Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668135
First Posted: April 29, 2008
Last Update Posted: December 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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)

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • Global Assessment Question [ Time Frame: 12 weeks ]
  • Other diary responses [ Time Frame: 12 weeks ]
  • Safety and tolerability [ Time Frame: 12 weeks ]

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668135


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668135     History of Changes
Other Study ID Numbers: 10657
First Submitted: April 25, 2008
First Posted: April 29, 2008
Last Update Posted: December 17, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents