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

Sponsor
University Medical Centre Ljubljana
Study ID
NCT03619330
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Dec 31, 2014
Status verified
Aug 2018
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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. ]

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