FDA Phase IV - Commitment - Retinal Function Study
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).
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Sildenafil, Placebo, Vardenafil (Levitra, BAY38-9456), Placebo
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00461565
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
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.
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.
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.
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