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 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT00631969
Eligibility Criteria:
Inclusion Criteria:
* Males 18 years-of-age or older
* Stable, heterosexual relationship for at least 6 months
* A history of erectile dysfunction (ED) for at least 6 months
Exclusion Criteria:
* Any underlying cardiovascular condition, including unstable angina pectoris
* History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
* Uncontrolled atrial fibrillation / flutter at screening
* History of surgical prostatectomy for prostate cancer
* Hereditary degenerative retinal disorders
* History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
* Presence of penile anatomical abnormalities
* Subjects who have been confirmed with phenylketonuria (PKU)
* Spinal cord injury
* Resting or postural hypotension or hypertension
* Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
* Use of any treatment for ED within 7 days of Visit 1
* History of congenital QT prolongation
* History of syncope within the last 6 months prior to entry into the study
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00631969
Study Brief:
Protocol Section:
NCT00631969