NCT03792321 (SETH2) is a Phase 4 clinical trial of Testosterone Undecanoate in Hypogonadism, Male, sponsored by University Medical Centre Ljubljana.

Who is sponsoring NCT03792321?

NCT03792321 is sponsored by University Medical Centre Ljubljana.

What drugs are being tested in NCT03792321?

Interventions in NCT03792321: Testosterone Undecanoate, Placebo.

What condition does NCT03792321 study?

NCT03792321 studies Hypogonadism, Male, Diabetes Mellitus, Type 2, Obesity.

Is NCT03792321 still recruiting?

NCT03792321 is currently completed. Last updated 4 January 2019.

Last reviewed 2019-01-04 · How we verify

NCT03792321: SETH2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)

Completed Phase 4 Last updated 4 January 2019

What this trial tests

Phase 4 trial testing Testosterone Undecanoate in Hypogonadism, Male in 55 participants. Completed in 5 March 2018.

Timeline

10 January 2014

Primary endpoint
5 March 2015

5 March 2018

Quick facts

Lead sponsor	University Medical Centre Ljubljana
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	55
Start date	10 January 2014
Primary completion	5 March 2015
Estimated completion	5 March 2018

Drugs / interventions tested

Testosterone Undecanoate (TESTOSTERONE UNDECANOATE) — full drug profile →
Placebo

Conditions studied

Hypogonadism, Male — all drugs for Hypogonadism, Male →
Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Obesity — all drugs for Obesity →

Sponsor

University Medical Centre Ljubljana

Who can join

35 and older, male only, with Hypogonadism, Male or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Aim of the study was to investigate the effects of testosterone replacement therapy on components of metabolic syndrome, vascular function and morphology, grade of non-alcoholic fatty liver disease (NAFLD), bone mineral density (BMD) and health-related quality of life.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Testosterone replacement in men with sexual dysfunction.
Lee H, Hwang EC, Oh CK, Lee S, et al · · 2024 · cited 17× · PMID 38224135 · DOI 10.1002/14651858.cd013071.pub2
Impact of testosterone therapy on bone turnover markers in obese males with type 2 diabetes and functional hypogonadism.
Groti Antonič K. · · 2022 · cited 4× · PMID 36355053 · DOI 10.1080/13685538.2022.2134338

Verify or expand the search:

Other trials of Testosterone Undecanoate

Trials testing the same drug.

NCT06188767 — Testosterone-induced Muscle Memory and Underlying Mechanisms · NA · recruiting
NCT05964920 — Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? · Phase 2, PHASE3 · completed
NCT05081193 — Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrat · Phase 2 · completed
NCT05541172 — Testosterone Undecanoate Replacement Therapy in Boys With Pubertal Delay or Confirmed Hypogonadism · unknown
NCT06489457 — The Effects of Semaglutide vs Testosterone Replacement Therapy on Functional Hypogonadism and Sperm Quality in Men With · Phase 3 · completed

Other recruiting trials for Hypogonadism, Male

Currently open trials in the same condition.

NCT06841328 — Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes · recruiting
NCT06532149 — ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer · recruiting
NCT04798469 — Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism · Phase 2 · recruiting
NCT04049331 — Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone · Phase 2 · recruiting
NCT04301765 — Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficienc · Phase 2 · recruiting

Other University Medical Centre Ljubljana trials

Trials by the same sponsor.

NCT07466472 — Image-Guided Central Catheter Insertion With Concurrent Assessment of Vascular Wall Integrity · not yet recruiting
NCT07446244 — Catheter Ablation of Advanced Forms of Atrial Fibrillation · NA · enrolling by invitation
NCT07109076 — Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton · NA · recruiting
NCT07354880 — Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease · Phase 4 · not yet recruiting
NCT07496736 — Post-exposure Influenza Prophylaxis in a Hospital Setting · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03792321 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Medical Centre Ljubljana
Last refreshed: 4 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03792321.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing