FDA Phase IV - Commitment - Retinal Function Study
Summary
Vardenafil (Levitra) and Sildenafil (Viagra) are drugs that are marketed for use in patients with erectile dysfunction. The purpose of this study is to find out if there are any changes in the eye after taking at least 15 doses of Vardenafil and after two doses of Sildenafil. This is a double-blind study, which means that neither you nor the study doctor will know which treatment you are receiving. If you qualify for the study, you will receive:
- Vardenafil 20 mg twice per week (Monday and Thursday) for a maximum of 8 weeks. There will be two times when this occurs during the study.
- Sildenafil 200 mg/day for two days. There will be two times when this occurs during the study.
- Placebo (a pill that looks like vardenafil or sildenafil but has no active ingredient).
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Safety
Intervention
Sildenafil, Placebo, Vardenafil (Levitra, BAY38-9456), Placebo
Status
Completed
Source
Bayer
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00461565
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Therapeutic Misconception
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Placebo Effect
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Safety
Freedom from exposure to danger and protection from the occurrence or risk of injury or loss. It suggests optimal precautions in the workplace, on the street, in the home, etc., and includes personal safety as well as the safety of property.
Food Safety
Activities involved in ensuring the safety of FOOD including avoidance of bacterial and other contamination.
United States Occupational Safety And Health Administration
An office in the Department of Labor responsible for developing and establishing occupational safety and health standards.
Clinical Trials
BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.
BAY38-9456 - Pivotal Trial for Diabetes Patient
The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was n...
A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability...
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:...
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)
PubMed Articles
For street samples suspected of containing the phosphodiesterase-5 inhibitors sildenafil (Viagra(®)) and/or vardenafil (Levitra(®)), including powders or adulterated herbal supplements, a chemical a...
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...
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...
PURPOSE: To evaluate the efficacy and safety of intravenous sildenafil for immediate postoperative pulmonary hypertension (PH) in pediatric patients undergoing congenital heart surgery. METHODS: A dou...
A simple, fast and sensitive HPLC method with electrochemical detection employing boron-doped diamond electrode (BDD) for the determination of sildenafil (Viagra™), vardenafil (Levitra™) and their...
