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Hormonal, cardiovascular, medical, muscle- and fitness aspects of sex hormone treatment in patients with Turner syndrome - project part B

Phase 1
Conditions
Ovarian dysgenesis and related hypogonadism causes by Turner syndrome
MedDRA version: 20.0Level: PTClassification code 10045181Term: Turner's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Registration Number
EUCTR2019-004934-40-DK
Lead Sponsor
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
Female
Target Recruitment
50
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

- 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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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