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:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT01106118
Eligibility Criteria:
Inclusion Criteria:
* Erectile Dysfunction (ED) patient who has newly been prescribed vardenafil (Levitra film-coated tablet) in accordance with the terms of the local marketing authorization.
* Diagnosis of erectile dysfunction at the discretion of the physician, based on the patients ED history.
* No use of any Phosphodiesterase Type 5 (PDE5) inhibitor within 1 month of study entry.
* Documented Metabolic Syndrome (MetS), preferably according to the definition of the International Diabetes Foundation.
Exclusion Criteria:
* Do not follow the contraindications and warnings of the Summary of Product Characteristics.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01106118
Study Brief:
Protocol Section:
NCT01106118