check_circleStudy Completed
Safety
Bayer Identifier:
11337
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
FDA Phase IV - Commitment - Retinal Function Study
Trial purpose
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).
Key Participants Requirements
Sex
MaleAge
18 - 55 YearsTrial summary
Enrollment Goal
63Trial Dates
February 2005 - October 2006Phase
Phase 4Could I Receive a placebo
YesProducts
Levitra (Vardenafil, BAY38-9456)Accepts Healthy Volunteer
YesPrimary Outcome
- The change from baseline in Fansworth Munsell (FM) 100 test total error score (TES) in both the left and right eyes for vardenafil treated subjects as compared to placebodate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue:
Secondary Outcome
- The change from baseline in Electroretinogram (ERG) as measured by amplitude and implicit time of b wave in both the left and right eyes for vardenafil treated subjects as compared to placebodate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue:
- Change in the FM-100 total error score from baseline at approximately 6 hours and 24 hours post dosedate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue:
- Safety and tolerability of 20 mg vardenafil after at least 15 oral doses of 20 mg vardenafil or placebo (dosed over approximately 8 weeks)date_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue:
- ERG and FM-100 total error score from baseline at approximately 2 hours following one dose of sildenafil 200 mgdate_rangeTime Frame:8 weeksenhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Crossover AssignmentTrial Arms
4