Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00656188
First received: April 4, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.


Condition Intervention Phase
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase 2
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 Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Erectile Function domain of the International Index of Erectile Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sexual Encounter Profile Question 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sexual Encounter Profile Question 3 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erectile Function domain scores > 26 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Sexual Encounter Profile 2 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Global Assessment Question [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reliability of insertion [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Reliability of maintenance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Other subject diary based variables [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 463
Study Start Date: October 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo
Active Comparator: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse

  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: NCT00656188

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00656188     History of Changes
Other Study ID Numbers: 10898, GSK 001
Study First Received: April 4, 2008
Last Updated: October 9, 2013
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 April 15, 2014