BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 24, 2008
Last updated: October 9, 2013
Last verified: October 2013

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.

Condition Intervention Phase
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase 3

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: 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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global Assessment Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Erectile Function domain score of the International Index of Erectile Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 480
Study Start Date: December 2002
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 2 Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 3 Drug: Levitra (Vardenafil, BAY38-9456)
20 mg Vardenafil orally 1 hour prior to sexual intercourse
Placebo Comparator: Arm 4 Drug: Placebo
5 mg matching placebo
Placebo Comparator: Arm 5 Drug: Placebo
10 mg matching placebo
Placebo Comparator: Arm 6 Drug: Placebo
20 mg matching placebo


Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00668057

China, Zhejiang
Hangzhou, Zhejiang, China, 310003
Beijing, China, 100083
Beijing, China, 100034
Beijing, China, 100044
Beijing, China, 100853
Shanghai, China, 200040
Shanghai, China, 200127
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT00668057     History of Changes
Other Study ID Numbers: 10690
Study First Received: April 24, 2008
Last Updated: October 9, 2013
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration

Keywords provided by Bayer:
Male Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 16, 2014