Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00678704
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
64 Years
Study:
NCT00678704
Study Brief:
Protocol Section:
NCT00678704