Trial Condition(s):

Erectile Dysfunction, Diabetes Mellitus

BAY38-9456 - Pivotal trial for diabetes patient

Bayer Identifier:

100607

ClinicalTrials.gov Identifier:

NCT00678704

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Inclusion Criteria
- Male with erectile dysfunction for more than 3 years according to the National Institutes of Health (NIH) Consensus Statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
 - Diabetes for more than 3 years
Exclusion Criteria
- Following to the labeling of Japanese package insert for vardenafil 5/10 mg, except for the highest dose
 - Spinal cord injury
 - History of surgical prostatectomy (excluding TURP)
 - Patients with an HbA1c > 12% at Visit 1
 - Use of nitrates
 - Use of potent CYP3a4 inhibitors
 - Severe liver disease
 - Presence of Peyronie's Disease

Trial Summary

Enrollment Goal
790
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteers
No

Where to Participate

Locations
Status
LocationsStatus

Trial Design