Study Completed

Erectile Dysfunction

Bayer Identifier:

100497

ClinicalTrials.gov Identifier:

NCT00658177

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Evaluating the Efficacy and Safety of flexible-dose Vardenafil in subjects with erectile dysfunction

Trial purpose

Study to investigate the efficacy and safety of Vardenafil

Key Participants Requirements

Sex

Male

Age

18 Years

Inclusion Criteria
- Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
- History of unresponsiveness to sildenafil
- Stable sexual relationship for > 6 month.
Exclusion Criteria
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy
- Other exclusion criteria apply according to the US Product Information

Trial summary

Enrollment Goal

463

Trial Dates

June 2003 - February 2004

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Levitra (Vardenafil, BAY38-9456)

Accepts Healthy Volunteer

Primary Outcome

Sexual Encounter Profile Question 2
Time Frame:
12 weeks
Safety Issue:
no

Secondary Outcome

Sexual Encounter Profile Question 3
Time Frame:
12 weeks
Safety Issue:
no
Internation Index of Erectile Function-Erectile Function domain
Time Frame:
12 weeks
Safety Issue:
no
Safety and tolerability
Time Frame:
12 weeks
Safety Issue:
yes

Trial design

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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