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Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00663130
First received: April 17, 2008
Last updated: June 29, 2009
Last verified: June 2009
History of Changes
  Purpose

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED


Condition Intervention Phase
Erectile Dysfunction
 Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Tadalafil
 Phase 4

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 Randomised, Double-Blind, Double-Dummy, Parallel-Group, Active-Controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Sexual Encounter Profile Question 3 (SEP-3) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual Encounter Profile Question 2 (SEP-2) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • International Index of Erectile Function [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Global Confidence Question (GCQ) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Erection Quality Scale (EQS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • General Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 759
Study Start Date: April 2004
Study Completion Date: July 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse
Active Comparator: Arm 2 Drug: Tadalafil
Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 64 years
  • Heterosexual males
  • Erectile dysfunction for more than 6 months

Exclusion Criteria:

  • Penile anatomical abnormalities
  • Spinal cord injury
  • History of surgical prostatectomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663130

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: Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00663130     History of Changes
Other Study ID Numbers: 11333
Study First Received: April 17, 2008
Last Updated: June 29, 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
Tadalafil
Vardenafil
 Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013