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 (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00663130
First received: April 17, 2008
Last updated: October 9, 2013
Last verified: October 2013
  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:


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
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

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:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00663130     History of Changes
Other Study ID Numbers: 11333
Study First Received: April 17, 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
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 April 17, 2014