Estradiol for Turner syndrome

Inclusion criteria

• {"criterion_text":"- Diagnosis of Turner syndrome regardless of karyotype (Turner syndrome)\n- Age 18-50 years (Turner syndrome and healthy controls)\n- Already receiving estrogen treatment (Turner syndrome)\n- Female (healthy controls)\n- Previously healthy (healthy controls)\n- Not receiving any medication (healthy controls)\n- Not using any form of contraceptive pills (healthy controls)\n- No mental or psychiatric disorders (healthy controls)"}

Exclusion criteria

• {"criterion_text":"- Active systemic chronic diseases\n- Known or suspected breast cancer\n- Known or suspected estradiol-dependent tumors (endometrial cancer or similar)\n- Untreated endometrial hyperplasia\n- Current or previous venous thromboembolism\n- Acute or previous liver disease where liver enzymes are still elevated by a factor 3 or more\n- Known hypersensitivity to the medications used\n- Pregnancy\n- Menopause (healthy controls only)"}

Primary endpoints

• {"endpoint_text":"- Body composition: measured by bio impedance","definition_or_measurement_approach":"measured by bio impedance"}
• {"endpoint_text":"- Blood test values: changes in the blood test values from baseline within the areas of metabolism, endocrinology, cardiovascular function, and coagulation","definition_or_measurement_approach":"changes in blood test values from baseline within areas of metabolism, endocrinology, cardiovascular function, and coagulation"}
• {"endpoint_text":"- Cardiovascular status: 24-hour ambulatory blood pressure monitoring and arterial stiffness (measured by SphygmoCor)","definition_or_measurement_approach":"24-hour ambulatory blood pressure monitoring and arterial stiffness measured by SphygmoCor"}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"MR scan of quadriceps measuring muscle CSA and fat content; maximal isometric quadriceps strength (functional tests); muscle quality defined as maximum quadriceps strength in nM divided by muscle CSA"}
• {"endpoint_text":"- Quadriceps strength test: maximal isometric muscle strength of both quadriceps measured simultaneously","definition_or_measurement_approach":"maximal isometric muscle strength of both quadriceps measured simultaneously"}
• {"endpoint_text":"- Isometric hand strength test: maximal hand strength measured in kilograms","definition_or_measurement_approach":"maximal hand strength measured in kilograms"}
• {"endpoint_text":"- Fitness: maximal oxygen uptake measured by a VO2max test","definition_or_measurement_approach":"maximal oxygen uptake measured by a VO2max test"}
• {"endpoint_text":"- Bones: bone mineral density as measured by a DEXA scan","definition_or_measurement_approach":"bone mineral density measured by DEXA scan"}
• {"endpoint_text":"- Jumping heigth: maximal jumping heigth measured in centimeters","definition_or_measurement_approach":"maximal jumping height measured in centimeters"}

Secondary endpoints

• {"endpoint_text":"- Self-reported health-related quality of life and functioning (SF-36)","definition_or_measurement_approach":"Self-reported health-related quality of life and functioning measured by SF-36"}
• {"endpoint_text":"- Self-reported quality of life (WHOQoL-Bref)","definition_or_measurement_approach":"Self-reported quality of life measured by WHOQoL-Bref"}
• {"endpoint_text":"- Subjective assesment of the medication after 6 months of oral and six months of transdermal treatment","definition_or_measurement_approach":"Subjective assessment of the medication after 6 months of oral and 6 months of transdermal treatment"}

Denmark

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

8

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Region Midtjylland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}