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Completed

NCT Number: NCT03619330

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

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.

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Key information

Conditions

Hypogonadism Body Weight Endocrine System Diseases Gonadal Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Treatment and study plan

liraglutide

Drug

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.

Other names: Victoza 6 mg/ml solution for injection in pre-filled pen

Testosterone

Drug

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

Other names: Androtop gel

Primary outcomes

  1. 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.

  2. The main outcome was change testosterone level.

    Time frame: 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.

  3. 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 outcomes

  1. 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.

  2. The secondary outcome was change in waist circumference.

    Time frame: 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.

Other outcomes

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

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

    Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.

  2. Other outcome was change in fasting concentration of insulin.

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

    Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L.

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

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

    HOMA IR index was calculated as fasting plasma glucose times fasting plasma insulin devided by 22.5

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2018
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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