Trial Condition(s):

Erectile Dysfunction

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Bayer Identifier:

10695

ClinicalTrials.gov Identifier:

NCT00661115

EudraCT Number:

Not Available

Study Completed

Trial Purpose

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Inclusion Criteria
- Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
 - having at least a 50% failure rate of sexual intercourse attempts during the run-in phase
Exclusion Criteria
- Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded. 
 - Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded. 
 - Subjects could not be on androgens/anti-androgens or alpha blockers.

Trial Summary

Enrollment Goal
173
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Mumbai, India, 400007

Status
Completed
 
Locations

Investigative Site

Belagum, India, 590010

Status
Completed
 
Locations

Investigative Site

Madurai, India, 625107

Status
Completed
 
Locations

Investigative Site

Mumbai, India, 400022

Status
Completed
 
Locations

Investigative Site

Bangalore, India, 560010

Status
Completed
 
Locations

Investigative Site

Bangalore, India, 560054

Status
Completed
 

Trial Design