Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00665340
First received: April 18, 2008
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multi-center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Erection Quality Scale [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erection Quality Scale [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
  • International Index of Erectile Function- Erectile Function domain score [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
  • Per-subject success rates based on Sexual Encounter Profile, Question 2 [ Time Frame: Week 4, 8 Week 8 ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
  • Patient Diary Questions [ Time Frame: Weeks 4, 8 Week 8 ] [ Designated as safety issue: No ]
  • Global Assessment Question (GAQ) [ Time Frame: Weeks 4, 8 of treatment and Week 8 ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) [ Time Frame: Week 8-LOCF ] [ Designated as safety issue: No ]
  • Penetration (SEP2) and Maintenance (SEP3) reliability [ Time Frame: Week 8-LOCF ] [ Designated as safety issue: No ]

Enrollment: 219
Study Start Date: July 2004
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1 Drug: Placebo
Matching placebo
Experimental: Arm 2 Drug: Levitra (Vardenafil, BAY38-9456)
5m, 10 mg and 20 mg 1 h 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:- Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older. Exclusion Criteria:- Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for > 6 month- Other exclusion criteria apply according to the US Product Information

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665340

Locations
United States, Arizona
Phoenix, Arizona, United States, 85023
United States, California
Beverly Hills, California, United States, 90212
Laguna Hills, California, United States, 92653
Newport Beach, California, United States, 92660
United States, Colorado
Aurora, Colorado, United States, 80012
United States, Connecticut
Trumbull, Connecticut, United States, 06611
United States, Florida
Aventura, Florida, United States, 33180
United States, New Jersey
Lawrenceville, New Jersey, United States, 08648
United States, New York
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Statesville, North Carolina, United States, 28677
Wilmington, North Carolina, United States, 28401
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00665340     History of Changes
Other Study ID Numbers: 11561
Study First Received: April 18, 2008
Last Updated: October 10, 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
Urological Agents

ClinicalTrials.gov processed this record on August 21, 2014