Estrogen replacement therapy (ERT) for treatment of adolescent anorexia nervosa

Estrogen replacement therapy (ERT) for treatment of adolescent anorexia nervosa – An open label study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000696-39-NO

Enrollment

Registered

2022-11-28

Start date

2023-02-21

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia nervosa

Interventions

Trade Name: Estradot Product Name: Estradot Product Code: G03CA03 Pharmaceutical Form: Transdermal patch

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are voluntary participation secured by written informed consent by the patient herself, in addition to consent from parents/next of kin, age between 13 to 18 years on inclusion, BMI =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: One or more contra indices for use of hormonal contraceptives, hereditary predisposition for venous or arterial thrombosis, any 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: This pilot study will test the feasibility and effect of estrogen replacment theraphy as treatment for anorexia nervosa. ;Secondary Objective: Not applicable;Primary end point(s): The present trial have two primary outcome variables, anxiety levels measured by STAI-C and specific symptoms of anorexia measured by the EDE-Q. The State Trait Anxiety Inventory – Children (STAI-C) (33) will be used to measure levels of state dependent and traits of anxiety. The Eating Disorder Exam Questionnaire version 6.0 (EDEQ-6.0) (34, 35) will be used to assess symptom levels of anorexia because these inventories are the considered as reliable, valid and highly utilized in clinical studies;Timepoint(s) of evaluation of this end point: 13 weeks duration of tretament	—

Measure

Time frame

Main Objective: This pilot study will test the feasibility and effect of estrogen replacment theraphy as treatment for anorexia nervosa. ;Secondary Objective: Not applicable;Primary end point(s): The present trial have two primary outcome variables, anxiety levels measured by STAI-C and specific symptoms of anorexia measured by the EDE-Q. The State Trait Anxiety Inventory – Children (STAI-C) (33) will be used to measure levels of state dependent and traits of anxiety. The Eating Disorder Exam Questionnaire version 6.0 (EDEQ-6.0) (34, 35) will be used to assess symptom levels of anorexia because these inventories are the considered as reliable, valid and highly utilized in clinical studies;Timepoint(s) of evaluation of this end point: 13 weeks duration of tretament

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 13 weeks of tretament.;Secondary end point(s): Secondary outcome measures are plasma levels of ghrelin, T3, T4, and cortisol measured in saliva. Furthermore, weight, and cognitive performance are secondary outcome measures.	—

Countries

Norway

Contacts

Public ContactHelen Sagerup

Helse-Nord

postmottak@helse-nord.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026