Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Placebo (Drug); Levitra (Vardenafil, BAY38-9456) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Assess the responsiveness of the Erection Quality Scale (EQS) to vardenafil HCl flexible dose
therapy versus placebo in men with Erectile Dysfunction
Clinical Details
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.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Erection Quality Scale
Secondary outcome: Erection Quality ScaleInternational Index of Erectile Function- Erectile Function domain score Per-subject success rates based on Sexual Encounter Profile, Question 2 Safety and tolerability Patient Diary Questions Global Assessment Question (GAQ) Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) Penetration (SEP2) and Maintenance (SEP3) reliability
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Phoenix, Arizona 85023, United States
Newport Beach, California 92660, United States
Beverly Hills, California 90212, United States
Laguna Hills, California 92653, United States
Aurora, Colorado 80012, United States
Trumbull, Connecticut 06611, United States
Aventura, Florida 33180, United States
Lawrenceville, New Jersey 08648, United States
Poughkeepsie, New York 12601, United States
Wilmington, North Carolina 28412, United States
Statesville, North Carolina 28677, United States
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: July 2004
Ending date: January 2005
Last updated: April 22, 2008
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