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

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 24, 2008
Last updated: December 18, 2014
Last verified: December 2014
Assess efficacy of vardenafil within 6 hours after intake

Condition Intervention Phase
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Phase 3

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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 887
Study Start Date: January 2003
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10mg orally on demand prior to intercourse


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00668018

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer Identifier: NCT00668018     History of Changes
Other Study ID Numbers: 10678 
Study First Received: April 24, 2008
Last Updated: December 18, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Bayer:
Male Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents processed this record on February 11, 2016