drugset / Trial / NCT06489457

The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With Type 2 Diabetes Mellitus and Obesity

NCT06489457

Phase 3 Completed 25 enrolled University Medical Centre Ljubljana
RandomizedParallel-groupOpen-labelTreatment

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 (a condition when levels of testosterone are decreased). The main questions the study aims to answer are: * Does semaglutide improve the quality of sperm? * Does semaglutide improve symptoms of hypogonadism as well as testosterone replacement? The researchers will compare semaglutide to testosterone replacement to see which drug better treats symptoms of hypogonadism. * The participants will receive testosterone replacement therapy (intramuscular injection every 10-12 weeks) or magnitude (subcutaneous injection once a week). * The treatment will last 24 weeks. * The participants will visit the clinic at the start and the end of the study. At the visit, the researchers will measure body weight and take a few blood samples. The participants will also be asked to complete several questionnaires and collect a sperm sample. The participants are free to terminate their participation in the study at any time without giving a reason.

Timeline

Start
2020-09-20
Primary completion
2023-05-11
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Semaglutide Peptide 1 mg Subcutaneous
Comparator Testosterone Undecanoate Small molecule 1000 mg Intramuscular