Overview
Sponsor-declared trial summary
Turner syndrome
To determine the equipotency of two different estradiol regimens (oral versus transdermal administration) using various estradiol-dependent surrogate markers
Key facts
- Sponsor
- Region Midtjylland, Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 29 Nov 2021 → ongoing
- Decision date (initial)
- 2024-10-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518557-42-00
- EudraCT number
- 2019-001881-14
- ClinicalTrials.gov
- NCT06544473
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy
To determine the equipotency of two different estradiol regimens (oral versus transdermal administration) using various estradiol-dependent surrogate markers
Conditions and MedDRA coding
Turner syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10045181 | Turner's syndrome | 100000004850 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Diagnosis of Turner syndrome regardless of karyotype (Turner syndrome)
- Age 18-50 years (Turner syndrome and healthy controls)
- Already receiving estrogen treatment (Turner syndrome)
- Female (healthy controls)
- Previously healthy (healthy controls)
- Not receiving any medication (healthy controls)
- Not using any kind of contraceptive pills (healthy controls)
- No mental or psychiatric disorders (healthy controls)
Exclusion criteria 9
- Active systemic chronic diseases
- Known or suspected breast cancer
- Known or suspected estradiol-dependent tumors (endometrial cancer or similar)
- Untreated endometrial hyperplasia
- Current or previous venous thromboembolism
- Acute or previous liver disease where liver enzymes are still elevated by a factor 3 or more
- Known hypersensitivity to the medications used
- Pregnancy
- Menopause (healthy controls only)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Equipotency: Levels of luthenizing hormone and follicle stimulating hormone are measured at different doses
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Estrofem, filmovertrukne tabletter
PRD341520 · Product
- Active substance
- Estradiol
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- 06697
- MA holder
- NOVO NORDISK A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD527570 · Product
- Active substance
- Estradiol
- Pharmaceutical form
- GEL
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- 13296
- MA holder
- ORION CORPORATION
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- 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
- Department of Endocrinology, Aarhus University Hospital
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Department of Endocrinology, Aarhus University Hospital
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2021-11-29 | 2021-11-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2019-001881-14 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ICF | 6 |
| Subject information and informed consent form (for publication) | L1_ICF_biobank | 3 |
| Subject information and informed consent form (for publication) | L1_SIS | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Divigel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Estrofem | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-01 | Denmark | Acceptable 2024-10-23
|
2024-10-23 |