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 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT06839651
Eligibility Criteria:
Inclusion Criteria:
* Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo.
* Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7
* History of undergoing treatment with sildenafil 100 mg for four sessions.
* Evaluation of IIEF-5 score \< 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4
* Type II Diabetes Melitus with an HbA1c test result of \< 7%.
* Laboratory test results for liver function (SGOT and SGPT) and kidney function (urea and creatinine) are within normal limits.
* Patients with undergoing treatment with antidepressant.
Exclusion Criteria:
* Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin.
* Active and significant systemic or local infection.
* History of bleeding or blood clotting disorder therapy.
* History of systemic autoimmune disorders and immunosuppressive treatment
* History of prostate surgery, history of malignancy, or a PSA level \> 4 ng/mL.
* Untreated hypogonadism or low serum total testosterone (\<200 ng/dL).
* Uncontrolled hypertension or hypotension (systolic blood pressure \>170 or \<90 mmHg, and diastolic blood pressure \>100 or \<50 mmHg).
* Unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the last 6 months, and congestive heart failure).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT06839651
Study Brief:
Protocol Section:
NCT06839651