Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00668018

First received: April 24, 2008

Last updated: March 8, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 24, 2008

Last Updated Date

March 8, 2010

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake [ 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 NCT00668018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

International Index of Erectile Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Global Assessment Question (GAQ) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Other diary responses [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
General Safety [ 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

Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

Official Title ^ICMJE

An Open-label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug

Brief Summary

Assess efficacy of vardenafil within 6 hours after intake

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Drug: Levitra (Vardenafil, BAY38-9456)

Vardenafil 10mg orally on demand prior to intercourse

Study Arm (s)

Experimental: Arm 1

Intervention: Drug: Levitra (Vardenafil, BAY38-9456)

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

1200

Completion Date

October 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age: 18 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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT Number ^ICMJE

NCT00668018

Other Study ID Numbers ^ICMJE

10678

Has Data Monitoring Committee

Responsible Party

Therapeutic Area Head, Bayer Schering Pharma AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

March 2010

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

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