Study Completed

Erectile Dysfunction

Bayer Identifier:

12770

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2008-003556-30

EU CT Number:

Not Available

BAY38-9456 MD Formulation selection 2 x 20 mg ER prototypes

Trial purpose

Please see attached Study Results Summary below

Key Participants Requirements

Sex

N/A

Age

45 - 70 Years

Trial summary

Enrollment Goal

Trial Dates

September 2008 - December 2008

Phase

Phase 1

Could I Receive a placebo

N/A

Products

Vardenafil ER (BAY38-9456)

Accepts Healthy Volunteer

N/A

Where to participate

Status	Institution	Location
Completed	Bayer HealthCare	Wuppertal, 42096, Germany

Trial design

Randomized study in a double-blind, 2-fold crossover, doubledummy multiple-dose design to investigate the safety, tolerability and pharmacokinetics of a 20 mg vardenafil extended release enteric-coated tablet formulation (E914) in comparison to a 20 mg vardenafil extended release anionic polymer tablet (E909) both formulations given od over 10 days in healthy male and female subjects

Trial Type

Interventional

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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