Turner Syndrome is a common chromosomal abnormalities, characterized by one X-chromosome or a partial deletion in all or some cell-lines. The syndrome is known for features as short stature and absent or insufficient puberty with subsequent infertility, but it may also imply symptoms from other organs f.ex. heart. Recent year’s research has documented a significantly raised morbidity as well as mortality among girls and adult women with Turner Syndrome.
Conditions
Interventions
Trade Name: Trisekvens
Product Name: Trisekvens
Product Code: 3601
Pharmaceutical Form: Tablet
INN or Proposed INN: 17-beta-estradiol
Concentration unit: mg milligram(s)
Concentration type: range
Conc
Sponsors
Pediatric Unit, Hillerød Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Criteria of inclusion to the sectional study (part A): - age between 10 to 21 years - diagnosed and verified (caryotype) Turner Syndrome Criteria’s of inclusion to the longitudinal study (part B): - age between 15 to 21 years - diagnosed and verified (caryotype) Turner Syndrome Are the trial subjects under 18? yes 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Criteria of exclusion to the sectional study (part A): - contradictions to the MR-scan - other severe or chronic sickness with a known or assumed impact on the parameters in the study (f.ex. epilepsy) evaluated by doctor Line Cleemann Criteria’s of exclusion to the longitudinal study (part B): - contradictions to the MR-scan - contradictions to the trial medication: a) known, earlier or clinical suspicion of breast cancer b) known or clinical suspicion of oestrogen dependant tumors (ex. endometrial cancer) c) undiagnosed bleeding from the vagina d) untreated endometrial hyperplasia e) actual or earlier venous tromboembolisme (deep venous thrombosis, thrombosis of the lungs) f) actual or earlier arterial tromboembolic disease g) acute or earlier liver disease, where the liver parameters have not yet normalized h) known hypersensitivity to the additives in the trial medication i) porphyry - conditions, other severe or chronic sickness with known or assumed impact on the parameters in the study or implying an unacceptable risk of relapse or worsening in receiving the trial medication (ex. Leiomyom or endometriosis a family history of or physical risk of tromboembolisme, risks of oestrogen dependant tumors, liver diseases as adenomas, diabetes, gall-stone-disease, migraine or severe headache, SLE, epilepsy, asthma, cardinal or renal dysfunction, familiar hyper triglycerides, earlier endometriosis hyperplasia) evaluated by doctor Line Cleemann - necessary intake of medications which will affect the effects of the trial medication (ex. certain anti-epileptic medicine, antibiotics, medicine containing pericum or imipramin) and where participation in the study will cause a too big risk for the patient and/or affect the test results, evaluated by doctor Line Cleemann
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -examine if a larger dosage of oestrogen than the one used to day will secure the development of a normal size uterus and thereby reduce the risk of complications in case of a future pregnancy and increase the bone mineralization with stronger bones as the result. ;Secondary Objective: - evaluate if aortic dilatation, a potential forerunner of later aortic dissection, is present in girls and young women with Turner Syndrome. - examine if oestrogen treatment will influence the emotional well-being and self-esteem in a positive manner in girls and young women with Turner Syndrome. ;Primary end point(s): The size of the uterus evaluated by MR-scan The bones evaluated by DEXA-scan Secondary: - The diameter of the aortic root evaluated by MR-scan - Development of biochemical markers - Body composition evaluated by DEXA-scan - Emotional well-being and self-esteem evaluated by questionnaires designed for the patients and their parents - The size of the uterus evaluated by ultrasound | — |
Countries
Denmark
Outcome results
None listed