Study Completed

Erectile Dysfunction

Bayer Identifier:

100536

ClinicalTrials.gov Identifier:

NCT00661297

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study evaluating the efficacy, safety, and reliability of Vardenafil

Trial purpose

Study to investigate the efficacy and safety of Vardenafil

Key Participants Requirements

Sex

Male

Age

18 Years

Inclusion Criteria
- Heterosexual males
- >/= 18 years old with ED for more than six months
- Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation
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 Summary of Product Characteristics

Trial summary

Enrollment Goal

523

Trial Dates

June 2003 - January 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 (SEP 2)
Time Frame:
12 weeks
Safety Issue:
no

Secondary Outcome

Sexual Encounter Profile question 3 (SEP 3)
Time Frame:
12 weeks
Safety Issue:
no
International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
Time Frame:
12 weeks
Safety Issue:
no
Safety and Tolerability
Time Frame:
12 weeks
Safety Issue:
yes

Trial design

A randomised, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety, and reliability of 10mg vardenafil administered for 12 weeks compared to placebo in subjects with erectile dysfunction

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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