Testosterone Replacement Therapy in Women with Turner Syndrome

2024-517755-12-00 Therapeutic exploratory (Phase II) Authorised, recruiting

Start 26 Feb 2026 · Status Authorised, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruiting
Participants planned 50
Countries 1
Sites 1

Turner Syndrome

The objective of this study is to evaluate the endocrine, physiological, cardiovascular neurocognitive, and genomic effects of transdermal TRT, as a supplement to ERT, in women with TS.

Key facts

Sponsor
Region Midtjylland
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Diseases [C] - Hormonal diseases [C19]
Trial duration
26 Feb 2026 → ongoing
Decision date (initial)
2025-04-22
Transition trial
No
Low-intervention
Yes
Rare-disease indication
Yes
Vulnerable population
No
Funding sources
Besins Healthcare

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Safety, Therapy

The objective of this study is to evaluate the endocrine, physiological, cardiovascular neurocognitive, and genomic effects of transdermal TRT, as a supplement to ERT, in women with TS.

Conditions and MedDRA coding

Turner Syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Turner Syndrome (all karyotypes)
  2. Age between 18 and 50 years (both included)
  3. Receiving estrogen replacement therapy
  4. Speaking Danish

Exclusion criteria 8

  1. Former or present untreated or uncontrolled chronic disease
  2. Diagnosed breast, cervical or endometrial cancer
  3. Grave obesity (BMI > 40)
  4. Heavy smoking (> 20 cigarettes/day)
  5. Allergy to the drug used
  6. Levels of androgen above normative levels
  7. Pregnancy and lactation
  8. Previous stroke, acute myocardial infarction or venous thromboembolism

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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.

Secondary endpoints 10

  1. Changes in quality of life
  2. Changes in inflammatory markers
  3. Changes in sexual function
  4. Changes in intramuscular sex hormone levels
  5. Changes in blood volume and hemoglobin mass
  6. Changes in coagulation parameters
  7. Changes in metabolic parameters
  8. Changes in neurocognitive function
  9. Changes in hypothalamus structure
  10. Changes in VO2-max, physical activity, muscle function and strength

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

ANDROGEL 25 mg, gel transdermique

PRD548516 · Product

Active substance
Testosterone
Pharmaceutical form
TRANSDERMAL GEL
Route of administration
TRANSDERMAL USE
Max daily dose
0.55 g gram(s)
Max total dose
201 g gram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
G03BA03 — TESTOSTERONE
Marketing authorisation
BE248421
MA holder
BESINS HEALTHCARE
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 4

Isopropyl Myristate

SUB14281MIG · Substance

Active substance
Isopropyl Myristate
Pharmaceutical form
OINTMENT
Route of administration
TRANSDERMAL USE
Max daily dose
2.7 mg milligram(s)
Max total dose
990 mg milligram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Carbomer 980

SUB22085 · Substance

Active substance
Carbomer 980
Pharmaceutical form
EYE GEL
Route of administration
TRANSDERMAL USE
Max daily dose
4.5 mg milligram(s)
Max total dose
1650 mg milligram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sodium Hydroxide

SUB12585MIG · Substance

Active substance
Sodium Hydroxide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
TRANSDERMAL USE
Max daily dose
26.4 mg milligram(s)
Max total dose
9636 mg milligram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ethanol (96 Per Cent)

SUB11946MIG · Substance

Active substance
Ethanol (96 Per Cent)
Pharmaceutical form
CUTANEOUS SOLUTION
Route of administration
TRANSDERMAL USE
Max daily dose
0.4 g gram(s)
Max total dose
146 g gram(s)
Max treatment duration
12 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

59 Total trials 36 Recruiting 13 Ended
Academic / Non-commercial
Sponsor organisation
Region Midtjylland
Address
Palle Juul-Jensens Boulevard 99
City
Aarhus N
Postcode
8200
Country
Denmark

Scientific contact point

Organisation
Region Midtjylland
Contact name
Claus Højbjerg Gravholt

Public contact point

Organisation
Region Midtjylland
Contact name
Claus Højbjerg Gravholt

Third parties 6

OrganisationCity, countryDuties
Aarhus University Hospital
ORG-100052990
 Aarhus N, Denmark Other
Department of Molecular Medicine, Aarhus University Hospital
ORL-000012785
 Denmark Laboratory analysis
Department of Public Health, Section for Sport Science, Aarhus University
ORL-000012343
 Denmark Other
Department of Clinical Biochemistry, Aarhus University Hospital
ORL-000012341
 Denmark Laboratory analysis
The Regional Pharmacy of the Central Denmark Region
ORL-000012784
 Denmark Code 14
Aarhus Universitet
ORG-100028380
 Aarhus N, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Authorised, recruiting 50 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Authorised, recruiting
Aarhus University Hospital
Department of Endocrinology and Internal Medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2026-02-26

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Temporary halt TH-120976

Halt date
2026-02-26
Planned restart
2026-12-01
Member states concerned
Denmark
Publication date
2026-02-26
Reason
Investigator/Site related, Medicinal Product related
Explanation
Temporary halt due to temporary unavailability of the Principal Investigator (maternity leave) and delay in IMP supply. We expect IMP to be delivered by the end of this year where we plan on starting recruitment.
Benefit-risk balance changed
No
Treatment stopped
No

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2024-517755-12-00 6
Protocol (for publication) D4_Patient facing documents Questionnaire B-PSQI 1
Protocol (for publication) D4_Patient facing documents Questionnaire FSFI-6 1
Protocol (for publication) D4_Patient facing documents Questionnaire SF-36 1
Protocol (for publication) D4_Patient facing documents Questionnaire WHOQOL-BREF 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 2
Recruitment arrangements (for publication) K2_Recruitment material Turner-foreningen 2
Subject information and informed consent form (for publication) L1_ICF 2
Subject information and informed consent form (for publication) L1_SIS 3
Subject information and informed consent form (for publication) L2_Other subject information Dine rettigheder som forsgsperson i forsg med medicin 1
Summary of Product Characteristics (SmPC) (for publication) E1_Reference to IB Testosterone Gel 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_DK 2
Synopsis of the protocol (for publication) D1_Protocol synopsis_ENG 2024-517755-12-00 2

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-01-02 Denmark Acceptable with conditions
2025-04-22
 2025-04-22
2 NON SUBSTANTIAL MODIFICATION NSM-1 2026-03-23 Denmark Acceptable with conditions
2025-04-22
 2026-03-23

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