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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT06058832
Eligibility Criteria:
Inclusion Criteria:
1. Ninety married men were diagnosed with T2DM participated in this study.
2. The patients complained from arteriogenic ED \> 6 months (Reisman et al., 2015) before the participation in this study
3. All patients aged between 35-55 years old.
4. Glycated hemoglobin (HbA1c) less than 9%.
5. Body mass index of the patients was \< 30 Kg/m2.
Exclusion Criteria:
1. Alcohol-abuse, illegal drug consumer patients.
2. Patients with cardiac diseases that prevent or affect sexual activity (heart attack, stroke, heart failure, myocardial infarction life-threatening, arrhythmia, etc within the previous 6 months).
3. Patients with any pulmonary, liver, or kidney diseases.
4. Patients with neurological insults, spinal cord injuries, stroke, polyneuropathy, etc.
5. Patients with diagnosed psychiatric/mental complaints.
6. Patients with blood pressure of more than 140/90 mmHg.
7. Patients with peripheral vascular disease.
8. Patients with venogenic ED.
9. Patients with past radical prostatectomy, extensive pelvic surgery, or previous pelvic trauma.
10. Patients recovering from cancer in the past 5 years
11. Penile anatomical abnormalities.
12. Patients with clinically significant chronic hematological disease.
13. Patients who received Anti-androgens or radiotherapy treatment of pelvic region.
14. Patients with untreated hypogonadism.
15. Patients with psychogenic ED (normal nocturnal penile tumescence parameters)
16. Patient with penile prosthesis
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
55 Years
Study:
NCT06058832
Study Brief:
Protocol Section:
NCT06058832