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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT06167733
Eligibility Criteria:
Inclusion Criteria:
* Adult, heterosexual, males between 22 and 85 years of age
* Subjects diagnosed with organic ED for at least 3 months, according to the American Urology Association (AUA) Guideline Statement 1 (as described in Section 8.1.1 of the study protocol).
* Subjects with an IIEF-EF score between 11-21
* Steady relationship for at least 3 months
* Subject is sexually active, with at least weekly sexual intercourse attempts or 6 times a month
* Subject is willing to sign informed consent and follow study protocol procedures
* Subject has a smartphone
Exclusion Criteria:
* Castrate and late onset hypogonadism
* History of Priapism or Peyronie's Disease
* Surgery or radiotherapy of the pelvic region
* Anatomic penile deformations or penile prosthesis
* Treatment with antiandrogens
* Previous whole gland treatment of the prostate (Cryoablation, HIFU, external beam radiation of seed implantation, Radical prostatectomy any approach, etc.)
* History of urothelial or colorectal cancer
* Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury, pelvic neuropathy
* Evidence of neurogenic bladder or an indwelling Foley catheter or clean intermittent catheterization (CIC) within 30 days
* Subjects who are taking anticoagulation or anti-platelet therapy
* History of psychiatric disorders, premature ejaculation and drug or alcohol abuse
* Subjects who are incarcerated
* Subjects who are cognitively challenged
* Serious heart or lung disease
* Pregnant partner
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
22 Years
Maximum Age:
85 Years
Study:
NCT06167733
Study Brief:
Protocol Section:
NCT06167733