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FDA Phase IV - Commitment - Retinal Function Study

NCT00461565 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2015-03-19

No results posted yet for this 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).

Conditions

  • Safety

Interventions

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).

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-02-28
Completion
2006-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00461565 on ClinicalTrials.gov