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Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00682019
First received: April 18, 2008
Last updated: June 12, 2009
Last verified: June 2009
History of Changes
  Purpose

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.


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

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: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Per-patient success rates based on Sexual Encounter Profile, Question 3 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Per-subject success rates based on Sexual Encounter Profile, Question 2 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • International Index of Erectile Function- Erectile Function domain score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Global Assessment Question (GAQ) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 383
Study Start Date: December 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 8 hours before sexual intercourse
Placebo Comparator: Arm 2 Drug: Placebo
matching placebo

  Eligibility

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

Inclusion Criteria:

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • Stable sexual relationship for > 6 month.

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682019

Sponsors and Collaborators
Bayer
GlaxoSmithKline
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 which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00682019     History of Changes
Other Study ID Numbers: 100493
Study First Received: April 18, 2008
Last Updated: June 12, 2009
Health Authority: United States: Food and Drug Administration

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 May 19, 2013