Hormonal, cardiovascular, medical, muscle- and fitness aspects of sex hormone treatment in patients with Turner syndrome - project part 1

Phase 1

• Conditions: Ovarian dysgenesis and related hypogonadism caused 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: EUCTR2019-001881-14-DK
• Lead Sponsor: Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-14
• Last Update Posted: 8 August 2022

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. Find the equipotency for different estradiol regimens, oral versus transdermal (TD) route of administration, using different estradiol-dependent surrogate markers.<br><br>;Secondary Objective: Not applicable ;Primary end point(s): Dose equivalence for tablet and gel therapy, which is the dosage that leads to the same levels of sex hormones in the blood of the participants.;Timepoint(s) of evaluation of this end point: Participants with Turner syndrome will have blood tests with female sex hormones taken on day 0 and day 14 of the study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None