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NCT03619330
Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.
Phase 4 trial testing liraglutide in Hypogonadism in 30 participants. Completed in 1 August 2015.
1 August 2015
Quick facts
| Lead sponsor | University Medical Centre Ljubljana |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 December 2014 |
| Primary completion | 1 August 2015 |
| Estimated completion | 1 August 2015 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- liraglutide (liraglutide) — full drug profile →
- Testosterone (TESTOSTERONE) — full drug profile →
Conditions studied
- Hypogonadism — all drugs for Hypogonadism →
- Obesity — all drugs for Obesity →
Sponsor
University Medical Centre Ljubljana
Who can join
Adults 18 to 65, male only, with Hypogonadism or Obesity. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The main outcome was improvements of symptoms related to hypogonadism
Time frame: Patients were screened and asked for symptoms at the beginning and every 4 weeks for 16 weeks of the study. -
The main outcome was change testosterone level.
Time frame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
Patient's blood was drawn between 8 and 9 a.m. Concentrations of testosterone was measured in nmol/L. -
the main outcome was change in gonadotropin levels.
Time frame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
Sponsor's own description
The purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03619330
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of liraglutide
Trials testing the same drug.
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- NCT05965908 — Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome · Phase 3 · completed
- NCT05681299 — Effects of GH and Lirglutide on AgRP · Phase 4 · recruiting
- NCT03292185 — A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec a · Phase 1 · completed
- NCT02964247 — LIRA-ADD2SGLT2i - Liraglutide Versus Placebo as add-on to SGLT2 Inhibitors. · Phase 3 · completed
Other recruiting trials for Hypogonadism
Currently open trials in the same condition.
- NCT06455969 — Adaptions and Resiliency to Multi-Stressor OpeRations · Phase 4 · recruiting
- NCT06280807 — Observation of Environment and Reproductive-Endocrine Effects · recruiting
- NCT04460872 — Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury · Phase 2 · recruiting
- NCT04731376 — Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testo · Phase 1 · active not recruiting
- NCT03887936 — Testosterone Therapy and Bone Quality in Men With Diabetes and Hypogonadism · Phase 4 · active not 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)
- Trial protocol + status: ClinicalTrials.gov NCT03619330 (US National Library of Medicine, public domain)
- 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: 6 August 2018
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/NCT03619330.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing