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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT06489457
Eligibility Criteria:
Inclusion criteria:
* type 2 diabetes mellitus,
* obesity (body mass index (BMI) higher or equal to 30 kg/m\^2),
* functional hypogonadism (defined by total testosterone less than 11 nmol/L and 2 or more symptoms of sexual dysfunction)
Exclusion criteria:
* Insulin treatment,
* glucagon-like peptide 1 (GLP-1) agonist treatment,
* sodium-glucose cotransporter-2 (SGLT-2) inhibitor treatment,
* other identified causes of hypogonadism,
* hemochromatosis,
* active malignant disease,
* thrombophilia,
* venous thrombosis within 6 months,
* recent acute myocardial infarction or stroke,
* prostate-specific antigen (PSA) higher than 3 ng/L,
* severe lower urinary tract symptoms with an International Prostate Symptom Score above 19,
* severe sleep apnea syndrome,
* hematocrit higher than 0.5,
* significant kidney or liver disease,
* ongoing treatment with opioid analgesics, antipsychotics, glucocorticoids,
* alcohol abuse,
* severe ongoing mental illness,
* personal history of pancreatitis or medullary thyroid carcinoma,
* personal or family history of multiple endocrine neoplasia type 2.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06489457
Study Brief:
Protocol Section:
NCT06489457