Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00668135

First received: April 25, 2008

Last updated: October 7, 2008

Last verified: October 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

October 7, 2008

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00668135 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Official Title ^ICMJE

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

Brief Summary

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)

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Drug: Vardenafil (Levitra, BAY38-9456)
Vardenafil 10 mg orally on demand prior to intercourse
Drug: Placebo
Matching placebo

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Vardenafil (Levitra, BAY38-9456)
Placebo Comparator: Arm 2
Intervention: Drug: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

413

Completion Date

April 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China, Indonesia, Malaysia, Philippines, Singapore, Thailand

Administrative Information

NCT Number ^ICMJE

NCT00668135

Other Study ID Numbers ^ICMJE

10657

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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