Clinical trial • Phase IV • Endocrinology | Rare Disease

TESTOSTERONE for Turner syndrome

Phase IV trial of TESTOSTERONE for Turner syndrome.

Overview

Trial Therapeutic Area: Endocrinology | Rare Disease
Trial Disease: Turner syndrome
Trial Stage: Phase IV
Drug Modality: Small molecule|Other

Key dates

Initial CTIS Submission Date: 02-01-2025
First CTIS Authorization Date: 22-04-2025

Trial design

Test: ANDROGEL 25 mg, gel transdermique (testosterone, transdermal gel). Comparator/placebo: formulation components listed as ISOPROPYL MYRISTATE, CARBOMER 980, SODIUM HYDROXIDE, ETHANOL (placebo/transdermal formulation). Dose/schedule details not specified beyond product name and daily maximum for ANDROGEL.-controlled Phase IV trial in Denmark.

Comparator: Test: ANDROGEL 25 mg, gel transdermique (testosterone, transdermal gel). Comparator/placebo: formulation components listed as ISOPROPYL MYRISTATE, CARBOMER 980, SODIUM HYDROXIDE, ETHANOL (placebo/transdermal formulation). Dose/schedule details not specified beyond product name and daily maximum for ANDROGEL.
Target Sample Size: 50
Trial Duration For Participant: 365

Eligibility

Recruits 50 Vulnerable population not selected. Participants are adult females aged 18-50; no special consent/assent handling described in the CTIS record..

Pregnancy Exclusion: Pregnancy and lactation
Vulnerable Population: Vulnerable population not selected. Participants are adult females aged 18-50; no special consent/assent handling described in the CTIS record.

Inclusion criteria

{"criterion_text":"- Turner Syndrome (all karyotypes)\n- Age between 18 and 50 years (both included)\n- Receiving estrogen replacement therapy\n- Speaking Danish"}

Exclusion criteria

{"criterion_text":"- Former or present untreated or uncontrolled chronic disease\n- Diagnosed breast, cervical or endometrial cancer\n- Grave obesity (BMI > 40)\n- Heavy smoking (> 20 cigarettes/day)\n- Allergy to the drug used\n- Levels of androgen above normative levels\n- Pregnancy and lactation\n- Previous stroke, acute myocardial infarction or venous thromboembolism"}

Endpoints

Primary endpoints

{"endpoint_text":"- Changes in body composition examined by total body dual-energy x-ray absorptiometry (DXA-scan) including bone mass, visceral and subcutaneous fat mass, and lean muscle mass, as well as measures of abdominal circumference and weight.","definition_or_measurement_approach":"Measured by total body dual-energy x-ray absorptiometry (DXA-scan); abdominal circumference and weight measurements."}

Secondary endpoints

{"endpoint_text":"- Changes in quality of life","definition_or_measurement_approach":"Patient-reported questionnaires (documents include WHOQOL-BREF and SF-36 listed in CTIS documents)."}
{"endpoint_text":"- Changes in inflammatory markers","definition_or_measurement_approach":""}
{"endpoint_text":"- Changes in sexual function","definition_or_measurement_approach":""}
{"endpoint_text":"- Changes in intramuscular sex hormone levels","definition_or_measurement_approach":""}
{"endpoint_text":"- Changes in blood volume and hemoglobin mass","definition_or_measurement_approach":""}
{"endpoint_text":"- Changes in coagulation parameters","definition_or_measurement_approach":""}
{"endpoint_text":"- Changes in metabolic parameters","definition_or_measurement_approach":""}
{"endpoint_text":"- Changes in neurocognitive function","definition_or_measurement_approach":""}
{"endpoint_text":"- Changes in hypothalamus structure","definition_or_measurement_approach":""}
{"endpoint_text":"- Changes in VO2-max, physical activity, muscle function and strength","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment: True, Turner-foreningen
Planned Sample Size: 50
Recruitment Window Months: 25
Consent Approach: Informed consent obtained from participants (adult females aged 18-50). Subject information and informed consent form documents are listed (L1_ICF, L1_SIS, L2 subject information). Protocol synopses available in English and Danish; materials suggest participant information available in Danish (and an English synopsis present). Assent not applicable.

Methods

Recruitment arrangements document (title: K1_Recruitment arrangements) present in CTIS documents
Recruitment material titled 'K2_Recruitment material Turner-foreningen' present in CTIS documents (suggests use of patient association materials)

Geography

Total Number Of Sites: 1
Total Number Of Participants: 50

Denmark

Earliest CTIS Part Ii Submission Date: 31-03-2025
Latest Decision Or Authorization Date: 22-04-2025
Processing Time Days: 22
Number Of Sites: 1
Number Of Participants: 50

Sites

Site Name: Aarhus University Hospital
Department Name: Department of Endocrinology and Internal Medicine
Principal Investigator Name: Claus Højbjerg Gravholt
Principal Investigator Email: claus.gravholt@clin.au.dk
Contact Person Name: Claus Højbjerg Gravholt
Contact Person Email: claus.gravholt@clin.au.dk
Number Of Participants: 50

Sponsor

Primary sponsor

Full Name: Region Midtjylland
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Denmark

Third parties

{"country":"Denmark","full_name":"Aarhus University Hospital","duties_or_roles":"MRI scans (MR Research Center at Aarhus University)","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Denmark","full_name":"Department of Molecular Medicine, Aarhus University Hospital","duties_or_roles":"code:4","organisation_type":"Health care"}
{"country":"Denmark","full_name":"Department of Public Health, Section for Sport Science, Aarhus University","duties_or_roles":"Functional tests","organisation_type":"Educational Institution"}
{"country":"Denmark","full_name":"Department of Clinical Biochemistry, Aarhus University Hospital","duties_or_roles":"code:4","organisation_type":"Health care"}
{"country":"Denmark","full_name":"The Regional Pharmacy of the Central Denmark Region","duties_or_roles":"code:14","organisation_type":"Health care"}
{"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"code:1","organisation_type":"Educational Institution"}

Investigational products

Investigational Product Name: ANDROGEL 25 mg, gel transdermique
Active Substance: TESTOSTERONE
Modality: Small molecule
Routes Of Administration: TRANSDERMAL USE
Route: TRANSDERMAL USE
Authorisation Status: Authorised (marketing authorisation BE248421)
Maximum Dose: 0.55 g per day (maxDailyDoseAmount)

Investigational Product Name: ISOPROPYL MYRISTATE
Active Substance: ISOPROPYL MYRISTATE
Modality: Small molecule
Routes Of Administration: TRANSDERMAL USE
Route: TRANSDERMAL USE
Authorisation Status: Not authorised
Maximum Dose: 2.7 mg per day (maxDailyDoseAmount)

Investigational Product Name: CARBOMER 980
Active Substance: CARBOMER 980
Modality: Other
Routes Of Administration: TRANSDERMAL USE
Route: TRANSDERMAL USE
Authorisation Status: Not authorised
Maximum Dose: 4.5 mg per day (maxDailyDoseAmount)

Investigational Product Name: ETHANOL (96 PER CENT)
Active Substance: ETHANOL (96 PER CENT)
Modality: Small molecule
Routes Of Administration: TRANSDERMAL USE
Route: TRANSDERMAL USE
Authorisation Status: Not authorised
Maximum Dose: 0.4 g per day (maxDailyDoseAmount)

Investigational Product Name: SODIUM HYDROXIDE
Active Substance: SODIUM HYDROXIDE
Modality: Other
Routes Of Administration: TRANSDERMAL USE
Route: TRANSDERMAL USE
Authorisation Status: Not authorised
Maximum Dose: 26.4 mg per day (maxDailyDoseAmount)

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