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

NCT06489457 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-07-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Semaglutide

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)

DRUG

Testosterone Undecanoate

Testosterone Undecanoate intramuscular injection 1000 mg once per 10-12 weeks

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Slovenia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489457 on ClinicalTrials.gov