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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT03886402
Eligibility Criteria:
Inclusion Criteria:
* history of ED of at least 3 months' duration
* have been taking a Phosphodiesterase type 5 (PDE5) inhibitor for at least 1 month prior and willing to stop taking any PDE5 inhibitor for duration of study
* have an IIEF-EF domain score that is ≥11 and ≤25
* have the same sexual partner for the duration of the study
* subject and partner willing to voluntarily give consent
* speak, read and understand English
Exclusion Criteria:
* non-responders to PDE5 inhibitor
* radical prostatectomy or other pelvic surgery or penile implant
* currently taking blood thinners, cancer drugs or HIV drugs
* allergic to lidocaine, epinephrine, valium
* diminished decision-making capacity
* use of tobacco
* previous pelvic or abdominal radiation therapy
* anti-androgen therapy
* untreated hypogonadism
* uncontrolled hypertension or hypotension
* unstable cardiovascular disease
* systemic autoimmune disorder
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03886402
Study Brief:
Protocol Section:
NCT03886402