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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT05345418
Eligibility Criteria:
Inclusion Criteria:
* Males with sexual hormone deficiency aged 50 to 70 years
* AMS score ≥ 27
* IIEF \< 14
* SQoL-M ≤ 87
* and Testosterone ≤ 12 nMol/L
* Normal liver function (ALT, AST and Bilirubin are normal according to biological index of Vietnamese people).
* Normal kidney function is usually according to the biological index of Vietnamese people.
* No infection, HIV, HBV, active syphilis.
* Must provide written informed consent.
Exclusion Criteria:
* The patient had surgery to remove the gonads.
* Patients with a history of cancer, or undergoing cancer treatment, or are positive for cancer screening tests including: PSA, AFP, Pepsinogen I, Pepsinogen II and erythrocyte smear test.
The patient is taking anti-rejection drugs.
* Patients with malformations, malformations or tumors of the endocrine glands.
* Endocrine impairment due to diabetes (HBA1c \> 7) and other metabolic diseases.
* Patients with active autoimmune disease or positive for antinuclear antibodies.
* Patients with severe heart failure, severe renal failure, severe liver failure, severe respiratory failure, history of cerebral infarction, myocardial infarction, Alzeimer.
* Patients with hypothyroidism.
* The patient has an acute infection.
* Patients with clinically significant coagulopathy or other hematological diseases.
* History of allergy to anesthetics, anesthetics, antibiotics.
* Patients who are using other hormone-improving drugs or supplements (including Sildenafil) in the last 2 weeks or want to continue using these drugs during the study period.
* The patient is a smoker.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
50 Years
Maximum Age:
70 Years
Study:
NCT05345418
Study Brief:
Protocol Section:
NCT05345418