Endocrine, Cardiovascular, Pharmacological, and Physiological Aspects of Sex Hormone Therapy in Turner Syndrome - Study 2
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Fitness: maximal oxygen uptake measured by a VO2max test
研究概览
简要总结
- Clarify endocrine, metabolic, cardiovascular, and thromboembolic risk factors in Turner syndrome after a washout period.
- Compare the effects of oral versus transdermal estrogen replacement therapy (ERT) in women with Turner syndrome.
- Examine the long-term effects of ERT via the two routes on endocrine, metabolic, cardiovascular, physiological, and thromboembolic risk endpoints.
研究设计
- 研究类型
- Interventional
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
- 是
入选标准
- •Diagnosis of Turner syndrome regardless of karyotype (Turner syndrome)
- •Age 18-50 years (Turner syndrome and healthy controls)
- •Already receiving estrogen treatment (Turner syndrome)
- •Female (healthy controls)
- •Previously healthy (healthy controls)
- •Not receiving any medication (healthy controls)
- •Not using any form of contraceptive pills (healthy controls)
- •No mental or psychiatric disorders (healthy controls)
排除标准
- •Active systemic chronic diseases
- •Known or suspected breast cancer
- •Known or suspected estradiol-dependent tumors (endometrial cancer or similar)
- •Untreated endometrial hyperplasia
- •Current or previous venous thromboembolism
- •Acute or previous liver disease where liver enzymes are still elevated by a factor 3 or more
- •Known hypersensitivity to the medications used
- •Menopause (healthy controls only)
结局指标
主要结局
Fitness: maximal oxygen uptake measured by a VO2max test
Fitness: maximal oxygen uptake measured by a VO2max test
Bones: bone mineral density as measured by a DEXA scan
Bones: bone mineral density as measured by a DEXA scan
Isometric hand strength test: maximal hand strength measured in kilograms
Isometric hand strength test: maximal hand strength measured in kilograms
Body composition: measured by bio impedance
Body composition: measured by bio impedance
Blood test values: changes in the blood test values from baseline within the areas of metabolism, endocrinology, cardiovascular function, and coagulation
Blood test values: changes in the blood test values from baseline within the areas of metabolism, endocrinology, cardiovascular function, and coagulation
Cardiovascular status: 24-hour ambulatory blood pressure monitoring and arterial stiffness (measured by SphygmoCor)
Cardiovascular status: 24-hour ambulatory blood pressure monitoring and arterial stiffness (measured by SphygmoCor)
Muscle quality: MR scan of both quadriceps measuring muscle cross-sectional area (CSA) and fat content of the muscle. Maximal isometric muscle strength of both quadriceps (functional muscle tests). Muscle quality = maximum quadriceps strength measured in nM/muscle CSA.
Muscle quality: MR scan of both quadriceps measuring muscle cross-sectional area (CSA) and fat content of the muscle. Maximal isometric muscle strength of both quadriceps (functional muscle tests). Muscle quality = maximum quadriceps strength measured in nM/muscle CSA.
Quadriceps strength test: maximal isometric muscle strength of both quadriceps measured simultaneously
Quadriceps strength test: maximal isometric muscle strength of both quadriceps measured simultaneously
Jumping heigth: maximal jumping heigth measured in centimeters
Jumping heigth: maximal jumping heigth measured in centimeters
次要结局
- Self-reported health-related quality of life and functioning (SF-36)
- Self-reported quality of life (WHOQoL-Bref)
- Subjective assesment of the medication after 6 months of oral and six months of transdermal treatment
研究者
Claus Højbjerg Gravholt
Scientific
Region Midtjylland