Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00668135

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 IV

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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:	413
Study Start Date:	March 2003
Study Completion Date:	April 2004

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Vardenafil (Levitra, BAY38-9456) Vardenafil 10 mg orally on demand prior to intercourse
Arm 2: Placebo Comparator	Drug: Placebo Matching placebo

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668135

Locations

China

Hong Kong, China
Indonesia

Jakarta, Indonesia, 10430
Malaysia

Kuala Lumpur, Malaysia

Kuala Lumpur, Malaysia, 51200
Malaysia, Salangor

Petlaing Jaya, Salangor, Malaysia, 47500
Malaysia, Sarawak

Kuching, Sarawak, Malaysia
Philippines

Manila, Philippines

Manila, Philippines, 150
Singapore

Singapore, Singapore, 119074

Singapore, Singapore, 169608

Singapore, Singapore, 529889
Thailand

Bangkok, Thailand

Bangkok, Thailand, 10700

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	10657
Study First Received:	April 25, 2008
Last Updated:	October 7, 2008
ClinicalTrials.gov Identifier:	NCT00668135
Health Authority:	Malaysia: Ministry of Health

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Vardenafil
Sexual Dysfunction, Physiological

Mental Disorders
Genital Diseases, Male
Erectile Dysfunction

Additional relevant MeSH terms:

Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Sexual and Gender Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009