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

Sponsor:	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

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:

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:

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
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

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

Petlaing Jaya, Salangor, Malaysia, 47500

Kuching, Sarawak, Malaysia

Kuala Lumpur, Malaysia

Kuala Lumpur, Malaysia, 51200
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

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 This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

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