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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04424394
Eligibility Criteria:
Inclusion Criteria:
1. Only Male patients who are 40 to 80 years old (both numbers inclusive).
2. Must have a body mass index (BMI) of less than 35.
3. Patients with ED for at least 1 year but less than 10 years.
4. The patient is poorly phosphodiesterase type 5 inhibitors responsive, meaning he is able to achieve an erection but is unable or partially able to satisfactory complete sexual intercourse (penetration and/or orgasm).
5. Minimum IIEF-EF domain score of 11-16 (for classification as moderate ED).
6. IIEF-ED score ≥11 and ≤25 while taking phosphodiesterase type 5 inhibitors or in injection therapy.
7. Be willing and capable of giving written informed consent to participate in this clinical study.
8. Be willing and capable of complying with study-related requirements, procedures and visits.
Exclusion Criteria:
1. Patients with history of radical prostatectomy or extensive pelvic surgery.
2. Patients with past radiation therapy of the pelvic region within 12 months prior to enrollment.
3. Patients recovering from cancer within 12 months prior to enrollment.
4. Patients who are taking blood thinners or have history of Diabetes Mellitus.
5. Patients with untreated hypogonadism or thyroid disease.
6. Patients with deformed Penis on physical exam form.
7. Patients who participated in another clinical trial or treatment with any investigational product within last 30 days prior to inclusion in the study.
8. Patients with serious neurological, psychological or psychiatric disorders which may affect erectile function.
9. Patients with other medical conditions determined by site principal investigator as interfering with the study.
10. Patients with an injury or disability claim under current litigation or pending or approved workers' compensation claim.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04424394
Study Brief:
Protocol Section:
NCT04424394