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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03619330
Other study ID # TESTOSTERON
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2014
Est. completion date August 2015

Study information

Verified date August 2018
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
liraglutide
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.
Testosterone
In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.

Locations

Country Name City State
Slovenia University Medical Center Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Other The other outcomes was changes changes in fasting concentrations of glucose. Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L. Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
Other Other outcome was change in fasting concentration of insulin. Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L. Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
Other Other outcome was change in HOMA IR index for insulin resistance. HOMA IR index was calculated as fasting plasma glucose times fasting plasma insulin devided by 22.5 Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.
Primary 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.
Primary 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.
Primary 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 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.
Secondary 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.
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