NCT00461565

FDA Phase IV - Commitment - Retinal Function Study

A Double Blind, Randomized, Placebo Controlled, Two Part, Two Session Balanced, Crossover Study to Evaluate Visual Changes in Healthy Male Subjects Aged 18 - 55 Years After Receiving: 1. at Least 15 Doses of 20 mg Vardenafil, Compared to Placebo and 2. Two Doses of Sildenafil, 200 mg Compared to Placebo

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Safety

Interventions

Type	Name	Description
DRUG	Sildenafil	A1) Two dosis of 200 mg Sildenafil orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
DRUG	Placebo	A2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
DRUG	Vardenafil (Levitra, BAY38-9456)	B1) At least 15 dosis of 20 mg Levitra orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).
DRUG	Placebo	B2) Matching Placebo orally. Patients receive either A1) or A2) in cross over design with either B1) or B2).

Timeline

• Start date: 2005-02-01
• Completion: 2006-10-01
• First posted: 2007-04-18
• Last updated: 2015-03-19