Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
Summary
This study investigates the safety and efficacy of a new dosage form of vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Conditions
Erectile Dysfunction
Intervention
Vardenafil ODT (BAY 38-9456), Placebo
Location
Chandler
Arizona
United States
85224
Status
Completed
Source
Bayer
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00655629
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Erectile Dysfunction
The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction.
Impotence, Vasculogenic
Inability to achieve and maintain an erection (ERECTILE DYSFUNCTION) due to defects in the arterial blood flow to the PENIS, defect in venous occlusive function allowing blood drainage (leakage) from the erectile tissue (corpus cavernosum penis), or both.
Penile Implantation
Surgical insertion of cylindric hydraulic devices for the treatment of organic ERECTILE DYSFUNCTION.
Yohimbine
A plant alkaloid with alpha-2-adrenergic blocking activity. Yohimbine has been used as a mydriatic and in the treatment of ERECTILE DYSFUNCTION. It is also alleged to be an aphrodisiac.
Penile Prosthesis
Rigid, semi-rigid, or inflatable cylindric hydraulic devices, with either combined or separate reservoir and pumping systems, implanted for the surgical treatment of organic ERECTILE DYSFUNCTION.
Clinical Trials
Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia
To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)
Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction
Compare once daily vs on demand treatment in men with erectile dysfunction Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:...
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 oc...
BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction
Purpose of the study is: - To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo - To assess...
Assess efficacy of Vardenafil in patients erectile dysfunction and high blood pressure
PubMed Articles
ABSTRACT Introduction. Men with erectile dysfunction (ED) are typically older and have one or more underlying cardiovascular conditions. Aim. To determine the efficacy and safety of a new orodispersib...
Results are reported from the first two adequate trials of the PDE-5 inhibitor vardenafil using a stopwatch to precisely measure erection duration in men with ED. Two randomized, multicenter, double-b...
The aim of the study is to evaluate the effect of simvastatin in erectile dysfunction (ED) secondary to endothelial dysfunction. This study is a double-blind, randomized, placebo-controlled, clinical...
ED is prevalent in hemodialysis (HD) patients, and closely related to poor sleep and depression. Efficacy of treating ED either with sildenafil or vardenafil has been shown to be beneficial in amelior...
