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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT05371951
Eligibility Criteria:
Inclusion Criteria:
* Male between 40 and 80 years old
* Known or suspected vasculogenic ED based on clinical history
* In an active sexual relationship with a minimum of 2 sexual attempts per month for at least one month prior to enrollment
* Suffering from ED for at least 6 months
* Testosterone level between 300 - 1000ng/dL within one month prior to enrollment
* Hgb A1C less than or equal to 8% within one month prior to enrollment
* Total IIEF-EF scores between 8-25
* EHS score greater than or equal to
Exclusion Criteria:
* ED due to radical prostatectomy, prior pelvic surgery, or radiation therapy to the pelvis within 12 months prior to enrollment
* Men with known neurogenic or psychogenic ED
* Anatomic malformations of the penis including Peyronie's disease
* Testosterone greater than 300ng/dL or 1000ng/dL
* Hgb A1C greater than 8%
* International Normalized Ratio greater than 2.5, and men on any blood thinners other than 81mg aspirin
* Active testicular or prostate cancer
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05371951
Study Brief:
Protocol Section:
NCT05371951