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

Sponsor
University Medical Centre Ljubljana
Study ID
NCT06489457
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    Semaglutide subcutaneous injection once weekly titrated to 1 mg in concordance with Summary of product characteristics (SmPC) (0.25 mg once weekly in the first month, 0.5 mg once weekly in the second month and 1 mg once weekly from the third month onward)
  • Testosterone Undecanoate — DRUG
    Testosterone Undecanoate intramuscular injection 1000 mg once per 10-12 weeks

Study Details

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.

Key Dates

Start date
Sep 20, 2020
Status verified
Jul 2024
Primary completion
May 11, 2023
Completion
Jun 30, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide Treatment
  • Active Comparator: Testosterone Replacement Therapy

Primary Outcome Measure

Change in semen volume from baseline and between the treatment arms [ Time Frame: Baseline and 24 weeks ]

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