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

Endocrine, cardiovascular, pharmacologic and physiologic aspects of sex hormone treatment in Turner syndrome - project part 1 - Aspects of sex hormone treatment in Turner syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001881-14-DK

Enrollment

Registered

2020-04-14

Start date

2021-03-19

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian dysgenesis and related hypogonadism caused 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

Interventions

Trade Name: Estrofem Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Estradiol Other descriptive name: ESTRADIOL Concentration unit: mg milligram(s) Concentration type: equal Concentratio

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 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

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. ;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.	—

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. ;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

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None	—

Countries

Denmark

Contacts

Public ContactMedical Research Lab

Department of Endocrinology and Internal Medicine, Aarhus Universityhospital

auh.doh.klinik@rm.dk004578455470

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026