Back to resultsTestosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.
Primary Purpose
Hypogonadism, Obesity
Status
Completed
Phase
Phase 4
Locations
Slovenia
Study Type
Interventional
Intervention
liraglutide
Testosterone
Sponsored by
About this trial
This is an interventional treatment trial for Hypogonadism
Eligibility Criteria
Sites / Locations
- University Medical Center Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
liraglutide
testosterone
Arm Description
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.
In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily.
Outcomes
Primary Outcome Measures
The main outcome was improvements of symptoms related to hypogonadism
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.
the main outcome was change in gonadotropin levels.
Secondary Outcome Measures
The secondary outcome was change in body weight.
The secondary outcome was change in waist circumference.
Patient's waist circumference was measured in centimeters.
Full Information
NCT ID
NCT03619330
First Posted
July 16, 2018
Last Updated
August 6, 2018
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT03619330
Brief Title
Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.
Official Title
Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypogonadism, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
liraglutide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
testosterone
Arm Type
Active Comparator
Arm Description
In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily.
Intervention Type
Drug
Intervention Name(s)
liraglutide
Other Intervention Name(s)
Victoza 6 mg/ml solution for injection in pre-filled pen
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Testosterone
Other Intervention Name(s)
Androtop gel
Intervention Description
In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.
Primary Outcome Measure Information:
Title
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.
Title
The main outcome was change testosterone level.
Description
Patient's blood was drawn between 8 and 9 a.m. Concentrations of testosterone was measured in nmol/L.
Time Frame
Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
Title
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.
Secondary Outcome Measure Information:
Title
The secondary outcome was change in body weight.
Time Frame
Patient's body weight in kilograms were measured at the base point and every four weeks during the 16 weeks of clinical trial.
Title
The secondary outcome was change in waist circumference.
Description
Patient's waist circumference was measured in centimeters.
Time Frame
Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial.
Other Pre-specified Outcome Measures:
Title
The other outcomes was changes changes in fasting concentrations of glucose.
Description
Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
Title
Other outcome was change in fasting concentration of insulin.
Description
Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.
Time Frame
Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
Title
Other outcome was change in HOMA IR index for insulin resistance.
Description
HOMA IR index was calculated as fasting plasma glucose times fasting plasma insulin devided by 22.5
Time Frame
Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Janez, MD, PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Learn more about this trial
Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.
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