2024-517755-12-00招募中2 期
Testosterone Replacement Therapy in Women with Turner Syndrome – Endocrine, Cardiovascular, Physiological, Neurocognitive and Genomic effects
Region Midtjylland1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年4月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in body composition examined by total body dual-energy x-ray absorptiometry (DXA-scan) including bone mass, visceral and subcutaneous fat mass, and lean muscle mass, as well as measures of abdominal circumference and weight.
研究概览
简要总结
The objective of this study is to evaluate the endocrine, physiological, cardiovascular neurocognitive, and genomic effects of transdermal TRT, as a supplement to ERT, in women with TS.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Turner Syndrome (all karyotypes)
- •Age between 18 and 50 years (both included)
- •Receiving estrogen replacement therapy
- •Speaking Danish
排除标准
- •Former or present untreated or uncontrolled chronic disease
- •Diagnosed breast, cervical or endometrial cancer
- •Grave obesity (BMI > 40)
- •Heavy smoking (> 20 cigarettes/day)
- •Allergy to the drug used
- •Levels of androgen above normative levels
- •Pregnancy and lactation
- •Previous stroke, acute myocardial infarction or venous thromboembolism
结局指标
主要结局
Changes in body composition examined by total body dual-energy x-ray absorptiometry (DXA-scan) including bone mass, visceral and subcutaneous fat mass, and lean muscle mass, as well as measures of abdominal circumference and weight.
Changes in body composition examined by total body dual-energy x-ray absorptiometry (DXA-scan) including bone mass, visceral and subcutaneous fat mass, and lean muscle mass, as well as measures of abdominal circumference and weight.
次要结局
- Changes in quality of life
- Changes in inflammatory markers
- Changes in sexual function
- Changes in VO2-max, physical activity, muscle function and strength
- Changes in intramuscular sex hormone levels
- Changes in blood volume and hemoglobin mass
- Changes in coagulation parameters
- Changes in metabolic parameters
- Changes in neurocognitive function
- Changes in hypothalamus structure
研究者
Claus Højbjerg Gravholt
Scientific
Region Midtjylland
研究点 (1)
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