NCT03619330

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

July 16, 2018

Last Update Submit

August 6, 2018

Conditions

HypogonadismObesity

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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.

Other Outcomes (3)

  • The other outcomes was changes changes in fasting concentrations of glucose.

    Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.

  • Other outcome was change in fasting concentration of insulin.

    Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.

  • Other outcome was change in HOMA IR index for insulin resistance.

    Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.

Study Arms (2)

liraglutide

ACTIVE COMPARATOR

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

testosterone

ACTIVE COMPARATOR

In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily.

Drug: Testosterone

Interventions

liraglutideDRUG

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.

Also known as: Victoza 6 mg/ml solution for injection in pre-filled pen
liraglutide
TestosteroneDRUG

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

Also known as: Androtop gel
testosterone

Sponsors & Collaborators

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

HypogonadismObesity

Interventions

LiraglutideSolutionsInjectionsTestosterone

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPharmaceutical PreparationsDrug Administration RoutesDrug TherapyTherapeuticsAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal Hormones

Study Officials

  • Andrej Janez, MD, PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor, MD, PhD

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 7, 2018

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

SL(1)