Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy
Summary
The objectives of this study are to evaluate the safety and efficacy of two doses of avanafil in the treatment of adult males for erectile dysfunction following bilateral nerve-sparing radical prostatectomy.
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Erectile Dysfunction
Intervention
Avanafil, Avanafil, Placebo
Location
Research Site
Bala Cynwyd
Pennsylvania
United States
Status
Recruiting
Source
VIVUS, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00895011
- 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
A Thorough EKG Safety Study of TA-1790 (Avanafil)
This study is to assess whether treatment with a therapeutic (100 mg) or supratherapeutic (800 mg) dose of avanafil has the potential to cause QT/QTc prolongation in healthy volunteers.
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subject...
The purpose of this study is primarily to evaluate whether taking avanafil with alcohol causes the blood pressure to fall.
Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED
This study is being conducted to compare the safety and efficacy of 3 doses of avanafil to placebo in men with mild to severe erectile dysfunction.
Drug Interaction Study of Avanafil and Enalapril or Amlodipine
The purpose of this study is to determine the change in the blood pressure and pulse rate, pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.
PubMed Articles
Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties.
Orally active, selective inhibitors of phosphodiesterase type 5 (PDE 5, cyclic GMP PDE), such as sildenafil, tadalafil and vardenafil, are currently the first-choice treatment options for the clinical...
Study Type - Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Avanafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for...
Avanafil, a new rapid-onset phosphodiesterase 5 inhibitor for the treatment of erectile dysfunction.
Importance of the field: Erectile dysfunction (ED) is a common sexual problem, affecting up to half of men over 50 years of age. Phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, tadalafil and v...
Rapid-screening detection of acetildenafils, sildenafils and avanafil by ion mobility spectrometry.
Ion mobility spectrometry was used as a rapid screening tool for the detection of acetildenafils, sildenafils and avanafil within adulterated herbal supplement matrices. Acetildenafils show a tendency...
Introduction: Phosphodiesterase type 5 inhibitors (PDE5-i) are used for the oral treatment of erectile dysfunction (ED). Since the launch of sildenafil more than 15 years ago, new molecules have becom...
