Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The main outcome was improvements of symptoms related to hypogonadism
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: liraglutide (Drug)
testosterone
In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily.
干预措施: Testosterone (Drug)
结局指标
主要结局
The main outcome was improvements of symptoms related to hypogonadism
时间窗: 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.
时间窗: 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.
the main outcome was change in gonadotropin levels.
时间窗: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
次要结局
- 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.)
研究者
Andrej Janez
professor, MD, PhD
University Medical Centre Ljubljana