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

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ClinicalTrials.gov Identifier: NCT00668018
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):

Brief Summary:
Assess efficacy of vardenafil within 6 hours after intake

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 887 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2003
Primary Completion Date : October 2003
Study Completion Date : October 2003

Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10mg orally on demand prior to intercourse

Primary Outcome Measures :
  1. Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. International Index of Erectile Function [ Time Frame: 12 weeks ]
  2. Global Assessment Question (GAQ) [ Time Frame: 12 weeks ]
  3. Other diary responses [ Time Frame: 12 weeks ]
  4. General Safety [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668018

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668018     History of Changes
Other Study ID Numbers: 10678
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Male Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents