Ovarian dysgenesis and related hypogonadism causes by Turner syndrome MedDRA version: 20.0 Level: PT Classification code 10045181 Term: Turner's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Conditions
Sponsors
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For participants with TS: - Diagnosis of TS regardless of karyotype - Age 18-50 years - Receives estrogen treatment in advance For the healthy controls: - Woman - Age 18-50 years - Formerly healthy and healthy - Does not receive medication - Does not use any contraceptive pills - Have no mental or psychiatric disorders Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Active systemic chronic diseases - Known with or with suspicion of breast cancer - Known or suspected estradiol-dependent tumors (endometrial cancer or similar) - Untreated endometrial hyperplasia - Current or past venous thromboembolism - Acute or previous liver disease, where liver enzymes are still elevated by at least a factor of 3 - Known hypersensitivity to active substances or excipients in any of the used medicines - Pregnancy - The menopause of the control group alone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Find the equipotency for different estradiol regimens, oral versus transdermal (TD) route of administration, using different estradiol-dependent surrogate markers. 2. Clarify the endocrine, metabolic, cardiovascular, physiologic and thromboembolic risk factors in Turner syndrome (TS) after a wash out period off estrogen. 3. To compare the effect of two different estradiol (E2) regimens, oral versus TD route, in terms of equipotency by using different estradiol-dependent surrogate markers. 4. To examine long term effects of E2 by the two administration routes on endocrine, metabolic, cardiovascular, physiologic and thromboembolic risk endpoints. ;Secondary Objective: Not applicable ;Primary end point(s): 1. Sex hormone level after a wash out period: The level of sex hormone imbalance after a wash out period without estrogen measured by the bloodsamples serum FSH and serum LH. 2. Blood test changes: The change in the blood test values from baseline within the areas of metabolism, endocrine, cardiovascular and coagulation. 3. Bones: Bone density measured by DEXA scan 4. Body composition: Measured by bio impedance 5. Cardiovascular status: 24 hours blood pressure measurement and a sphygmocor scan 6. Hand strength test: Maximal hand strength meassured in kg 7. Quadriceps strength test: Maximal isometric muscle strength of both quadriceps meassured at once in nM. 8. Muscle quality: MR scan of both quadriceps: to measure muscle cross-sectional area (CSA) and fat content in the muscle. Muscle quality = maximum quadriceps strength meassured in nM/muscle CSA. 9. Fitness: Meassured with a bike test: fat oxidation test with increasing intensity - 5 min break - VO2max test with the value: ml/O2/kg 10. Jumping height: maximal jumping height meassured in cm;Timepoint(s) of evaluation of this end point: For all the endpoints evaluation after 1 month (the first wash out period), after 6 months (the first intervention period) and after further 7 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 11. Experienced health-related quality of life and functioning: Self-reported quality of life questionnaires - SF-36. It consists of eight scaled scores. Each scale is transformed directly into a 0-100 scale. The lower the score the greater the difficulty. 12. Life quality: Self-reported quality of life questionnaires - WHOQoL-Bref. Based on the participant's answer to the 26 questions in the questionnaire, an overall quality of life profile for the participant is formed, which consists of a quality of life score for each dimension of the questionnaire. These are physical health, mental health, social relationships and the participants' surroundings. ;Timepoint(s) of evaluation of this end point: Evaluation after 1 month (the first wash out period), after 6 months (the first intervention period) and after further 7 months (the second wash period and second intervention period). | — |
Countries
Denmark
Contacts
Public ContactMedical Research Lab
Diabetes and Hormone Diseases, Aarhus Universityhospital
Outcome results
None listed