Estrogen replacement therapy (ERT) for treatment of adolescent anorexia nervosa – An open label study
interventional
N/A
1 country
1
Brief Summary
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Reported enrollment (type unavailable)
- Not reported
- Study completion date
Not reported
Date not reported- Listed locations
- 1 countries · 1 sites
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
January 22, 2025
Actual (reported)
Conditions
Outcome Measures
Primary Outcomes (1)
Anxiety levels measured by STAI-C and specific symptoms of anorexia measured by the EDE-Q
Secondary Outcomes (1)
Cortisol, ghrelin, T3, T4 levels, weight gain, cognitive performance (WCST, CVLT II), and Beck Youth Inventory scores
Interventions
Registry intervention entries
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Estradot 50 mikrog/24 timer depotplaster
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TRANSDERMAL PATCH
View registry record
Ingredients named in source formulations
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Estradot 50 mikrog/24 timer depotplaster
Named ingredient: Estradiol
View registry record
Eligibility Criteria
You may qualify if:
- Patients with anorexia nervosa, and anorexia with concomitant anxiety and depression will be included.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitetssykehuset Nord-Norge HFType not reportedlead
Study Sites (1)
Universitetssykehuset Nord-Norge HF
Tromsoe, 9019, Norway
Central Study Contacts
Klinisk Forskningsavdeling
Study Design
- Study Type
- interventional
- Phase
- phase 2
Study Record Dates
First Submitted
January 22, 2025
Source record
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- 2024-519908-27-01
- Data provider
- European Medicines Agency (EMA)
- Normalization version
- ctis-v1
Source retrieved:
Documents
- Protocol_NoMA
- Synopsis of Estrogen Replacement Therapy for Adolescent Anorexia Nervosa
- SmPC_50_estradot
- informedconsent_recruitment
- Infoskriv_Ungdom_revidert
- Infoskriv_Voksne_revidert
- Infoskriv_foresatte_revidert_140822