Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.

Phase 4

Completed

• Conditions: Hypogonadism; Obesity
• Interventions: Drug: liraglutide; Drug: Testosterone

• Registration Number: NCT03619330
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Study First Submitted: 2018-07-16
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-06
• Last Update Submitted: 2018-08-06
• Study First Posted: 2018-08-07
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liraglutide	liraglutide	In the LIRA group liraglutide was initiated at a dose of 1.2 mg injected sc once per day and increased to 3 mg/day after 1 week.
testosterone	Testosterone	In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily.

Primary Outcome Measures

Name	Time	Method
The main outcome was improvements of symptoms related to hypogonadism	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.	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.	Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.

Secondary Outcome Measures

Name	Time	Method
The secondary outcome was change in body weight.	Patient's body weight in kilograms were measured at the base point and every four weeks during the 16 weeks of clinical trial.
The secondary outcome was change in waist circumference.	Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial.	Patient's waist circumference was measured in centimeters.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia