Status:
COMPLETED
The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
Type 2 Diabetes Mellitus
Obesity
Eligibility:
MALE
18-65 years
Phase:
PHASE3
Brief Summary
The goal of this study is to learn whether semaglutide (treatment for type 2 diabetes and obesity) can improve signs and symptoms of hypogonadism in men with type 2 diabetes, obesity and hypogonadism ...
Detailed Description
Men aged 18 - 65 years with type 2 diabetes on oral antidiabetic treatment, body mass index above 30 kg/m2 and functional hypogonadism (total testosterone below 11 nmol/L and at least 2 symptoms of hy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06489457
Start Date
September 20 2020
End Date
June 30 2023
Last Update
July 8 2024
Active Locations (1)
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1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000