Overview
Sponsor-declared trial summary
Anorexia Nervosa
The present project is a pilot study that aim to test the efficacy and feasibility of estrogen replacement therapy on psychological and physiological symptoms in girls with anorexia nervosa. Hence, if this pilot study shows results that the estrogen replacement treatment is feasible and the included patients show an im…
Key facts
- Sponsor
- Universitetssykehuset Nord-Norge HF
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- completed 14 Apr 2026
- Decision date (initial)
- 2025-01-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Health Authorities Northern Norway
External identifiers
- EU CT number
- 2024-519908-27-01
- EudraCT number
- 2022-000696-39
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The present project is a pilot study that aim to test the efficacy and feasibility of estrogen replacement therapy on psychological and physiological symptoms in girls with anorexia nervosa. Hence, if this pilot study shows results that the estrogen replacement treatment is feasible and the included patients show an improvement in anorectic symptoms, we will test this treatment in a full-scale randomized placebo-controlled trial. The pilot study will be performed within the health region of Northern Norway, UNN-HF. The drug that will be tested in the present study is already on the market and used for other purposes. Thus, the implementation of estrogen replacement therapy in clinical practice can therefore easily be performed and will provide options for improved treatment for patients with anorexia. The project fit the scope of the call that define clinical research and translational research as aims.
Conditions and MedDRA coding
Anorexia Nervosa
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519908-27-00 | Estrogen replacement therapy (ERT) for treatment of adolescent anorexia nervosa – An open label study | Universitetssykehuset Nord-Norge HF |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients with anorexia nervosa, and anorexia with concomitant anxiety and depression will be included.
Exclusion criteria 1
- One or more contra indices for use of hormonal contraceptives, hereditary predisposition for venous or arterial thrombosis, any previous unexplained vaginal bleeding, diagnosed or susceptible diabetes mellitus, any cerebrovascular disease, any type of heart failure, any neurological disease or structural brain damage, any past or present episodes of psychosis or mania, any current use of antipsychotic medication, diagnoses of mental retardation (F70-F79), pregnancy, past or present substance abuse.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Anxiety levels measured by STAI-C and specific symptoms of anorexia measured by the EDE-Q
Secondary endpoints 1
- Cortisol, ghrelin, T3, T4 levels, weight gain, cognitive performance (WCST, CVLT II), and Beck Youth Inventory scores
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Estradot 50 mikrog/24 timer depotplaster
PRD10486628 · Product
- Active substance
- Estradiol
- Substance synonyms
- ESTRADIOL ANHYDROUS, OESTRADIOL, OESTRADIOL-17-BETA, 17BETA-ESTRADIOL
- Pharmaceutical form
- TRANSDERMAL PATCH
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 50.00 µg microgram(s)
- Max total dose
- 4550 µg microgram(s)
- Max treatment duration
- 13 Week(s)
- Authorisation status
- Authorised
- ATC code
- G03CA03 — ESTRADIOL
- Marketing authorisation
- 01-7394
- MA holder
- SANDOZ A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitetssykehuset Nord-Norge HF
- Sponsor organisation
- Universitetssykehuset Nord-Norge HF
- Address
- Hansine Hansens Veg 67
- City
- Tromsoe
- Postcode
- 9019
- Country
- Norway
Scientific contact point
- Organisation
- Universitetssykehuset Nord-Norge HF
- Contact name
- Klinisk Forskningsavdeling
Public contact point
- Organisation
- Universitetssykehuset Nord-Norge HF
- Contact name
- Klinisk Forskningsavdeling
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ended | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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) | Protocol_NoMA | 4 |
| Recruitment arrangements (for publication) | informedconsent_recruitment | 1 |
| Subject information and informed consent form (for publication) | Infoskriv_foresatte_revidert_140822 | 4 |
| Subject information and informed consent form (for publication) | Infoskriv_Ungdom_revidert | 1 |
| Subject information and informed consent form (for publication) | Infoskriv_Voksne_revidert | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_50_estradot | 1 |
| Synopsis of the protocol (for publication) | Synopsis of Estrogen Replacement Therapy for Adolescent Anorexia Nervosa | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-22 | Norway | Acceptable with conditions 2025-01-24
|
2025-01-24 |