Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 52 of 213 for:    "Hypogonadism" | "Androgens"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03619330
Recruitment Status : Completed
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Hypogonadism Obesity Drug: liraglutide Drug: Testosterone Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: liraglutide
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
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 Name: Victoza 6 mg/ml solution for injection in pre-filled pen

Active Comparator: testosterone
In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily.
Drug: Testosterone
In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.
Other Name: Androtop gel




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619330


Locations
Layout table for location information
Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Layout table for investigator information
Principal Investigator: Andrej Janez, MD, PhD University Medical Centre Ljubljana

Layout table for additonal information
Responsible Party: Andrej Janez, professor, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03619330     History of Changes
Other Study ID Numbers: TESTOSTERON
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypogonadism
Androgens
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Gonadal Disorders
Endocrine System Diseases
Liraglutide
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hypoglycemic Agents
Incretins