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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00668057

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.

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

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:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

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:	December 2003

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Vardenafil (Levitra, BAY38-9456) 5 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 2	Drug: Vardenafil (Levitra, BAY38-9456) 10 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 3	Drug: Vardenafil (Levitra, 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

Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT00668057

Locations

China, Zhejiang

Hangzhou, Zhejiang, China, 310003
China

Beijing, China, 100034

Beijing, China, 100044

Beijing, China, 100083

Beijing, China, 100853

Shanghai, China, 200040

Shanghai, China, 200127

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00668057 History of Changes
Other Study ID Numbers:	10690
Study First Received:	April 24, 2008
Last Updated:	March 8, 2010
Health Authority:	China: State 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
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012