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Study on Estradiol for Treating Anorexia Nervosa in Adolescent Girls

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of Estrogen Replacement Therapy (ERT) in treating anorexia nervosa in adolescents. Anorexia nervosa is an eating disorder characterized by an intense fear of gaining weight and a distorted body image, leading to restricted food intake and excessive weight loss. The treatment being tested is a transdermal patch called Estradot, which contains the active substance estradiol. Estradiol is a form of estrogen, a hormone that plays a crucial role in the development and regulation of the female reproductive system and secondary sexual characteristics.

The purpose of this study is to explore whether ERT can help improve both psychological and physical symptoms in girls with anorexia nervosa. The study is designed as an open-label trial, meaning that both the researchers and participants know what treatment is being administered. If the results are promising, this could lead to a larger study comparing ERT with a placebo. The trial will involve participants using the estradiol patch over a period of time, with regular assessments to monitor changes in symptoms and overall health.

Participants in the study will be monitored for changes in anxiety levels, specific symptoms of anorexia, and other health indicators such as hormone levels and cognitive performance. The study aims to determine if ERT is a feasible and effective treatment option for anorexia nervosa, potentially offering a new approach to managing this challenging condition. The findings could pave the way for incorporating ERT into clinical practice, providing additional treatment options for patients with anorexia nervosa.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Introduction to the trial
The trial focuses on estrogen replacement therapy for treating adolescent anorexia nervosa.
The study is open-label, meaning both the patient and the researchers know the treatment being administered.
Step 2
Eligibility confirmation
Patients with anorexia nervosa, including those with anxiety and depression, are eligible to participate.
No specific exclusion criteria are mentioned.
Step 3
Treatment administration
The treatment involves the use of a transdermal patch called Estradot 50 micrograms/24 hours depot patch.
The patch contains estradiol and is applied to the skin for continuous delivery of the medication.
Step 4
Monitoring and assessment
Primary assessments include measuring anxiety levels using the STAI-C and specific anorexia symptoms using the EDE-Q.
Secondary assessments involve monitoring cortisol, ghrelin, T3, T4 levels, weight gain, cognitive performance, and Beck Youth Inventory scores.
Step 5
Trial duration
The estimated end date for the trial is April 4, 2025.
The recruitment for the trial began on April 4, 2022.

Who can join the trial?

4 criteria

The study is for patients who have been diagnosed with anorexia nervosa. This is an eating disorder where people have a strong fear of gaining weight and may eat very little.
Patients who have anorexia nervosa along with anxiety or depression can also participate. Anxiety is when you feel very worried or nervous, and depression is when you feel very sad or hopeless for a long time.
Only female patients can join this study.
The study is for girls who are in the age range of 10 to 17 years old.

Who cannot join the trial?

2 criteria

Participants cannot be male. Only females are eligible for this study.
Participants must not belong to a vulnerable population. This means they should not be in a group that might be at higher risk of harm or exploitation.

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Verified sites

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Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

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Investigated drugs

Estrogen Replacement Therapy (ERT) is being tested in this study to see if it can help improve both psychological and physical symptoms in girls with anorexia nervosa. This therapy involves using estrogen, a hormone that is already available and used for other health issues, to see if it can be beneficial for treating anorexia. The goal is to determine if this treatment is effective and can be easily used in clinical settings to provide better care for patients with anorexia.

Estradiol

What is already known about the treatment

Estrogen Replacement Therapy (ERT) – This medication is administered orally or through skin patches and is currently being studied for its potential benefits in treating anorexia nervosa in adolescent girls. While ERT is already available on the market for other uses, this study aims to explore its effectiveness in improving both psychological and physiological symptoms associated with anorexia. The therapy works by supplementing estrogen levels, which may help in regulating mood and physical health. It is classified under hormone replacement therapies and is being evaluated for its feasibility and impact in a pilot study, with plans for further research if initial results are promising.

Investigated diseases

Anorexia Nervosa – Anorexia nervosa is an eating disorder characterized by an intense fear of gaining weight and a distorted body image, leading individuals to restrict their food intake severely. People with this condition often see themselves as overweight, even if they are underweight. The disorder can lead to extreme weight loss and malnutrition, affecting physical health and mental well-being. As the condition progresses, individuals may experience symptoms such as fatigue, dizziness, and a weakened immune system. Psychological symptoms can include anxiety, depression, and obsessive behaviors related to food and body image. The disorder often requires a comprehensive approach to address both the physical and psychological aspects.