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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:
ClinicalTrials.gov Identifier:
NCT00663130
First Posted: April 22, 2008
Last Update Posted: October 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Sexual Encounter Profile Question 3 (SEP-3) [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Sexual Encounter Profile Question 2 (SEP-2) [ Time Frame: 4 weeks ]
  • International Index of Erectile Function [ Time Frame: 4 weeks ]
  • Global Confidence Question (GCQ) [ Time Frame: 4 weeks ]
  • Erection Quality Scale (EQS) [ Time Frame: 4 weeks ]
  • General Safety [ Time Frame: 4 weeks ]

Enrollment: 759
Study Start Date: April 2004
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes 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
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): NCT00663130


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00663130     History of Changes
Other Study ID Numbers: 11333
First Submitted: April 17, 2008
First Posted: April 22, 2008
Last Update Posted: October 11, 2013
Last Verified: October 2013

Keywords provided by Bayer:
Erectile Dysfunction
Vardenafil

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