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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.

Conditions
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Hypogonadism, Obesity

Intervention / Treatment
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* Drug: liraglutide
* Drug: Testosterone


Participation Criteria
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Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: liraglutide<br>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. | Drug: liraglutide<br>* In the liraglutide 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.<br>* Other names: Victoza 6 mg/ml solution for injection in pre-filled pen;|
| Active Comparator: testosterone<br>In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily. | Drug: Testosterone<br>* In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.<br>* Other names: Androtop gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 between 8 and 9 a.m. Concentrations of testosterone was measured in nmol/L. | Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial. | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 in centimeters. | Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial. |