Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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

This study is exploring if using an oestrogen patch might help young women and adolescent girls who have anorexia nervosa. Anorexia nervosa is a serious eating disorder. The researchers want to see if the oestrogen patch can help with worries and anxiety, as well as other common symptoms of anorexia. They will also look at whether it helps with things like weight gain, memory, and certain hormone levels. This is a small, early-stage study (Phase II), meaning it's one of the first steps to see if this treatment could be beneficial. It's open to female participants of any age who have anorexia nervosa. The goal is to understand if this approach could be a helpful addition to existing treatments.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitetssykehuset Nord-Norge HF

Enrolment target

Start

24 Jan 2025

Anorexia Nervosa

What is this study about?

This study is about understanding if a type of hormone treatment, specifically an oestrogen patch, could be helpful for young women and adolescent girls living with anorexia nervosa. Anorexia nervosa is a serious condition that affects how people think about food and their body weight, often leading to extreme weight loss and other health problems. Dealing with anorexia can also involve a lot of worry and anxiety.

The researchers want to see if applying an oestrogen patch, which delivers the hormone through the skin, can help make a difference. They're particularly interested in whether it can reduce feelings of anxiety and improve other key symptoms of anorexia. This is an exploratory study, meaning it's one of the first steps in looking at this treatment in people with anorexia, to understand if it's worth studying further.

By taking part, you would help doctors learn more about potential new ways to support young people with anorexia nervosa. The information gathered will be crucial for developing better treatments in the future, aiming to improve both the physical and mental well-being of those affected.

Key takeaways

This study explores using an oestrogen patch for anorexia nervosa.
It aims to see if it helps with anxiety and other symptoms.
It's an early-stage study to find new treatment options.
Only female participants with anorexia nervosa can join.
Participation involves using a patch and attending regular assessments.

Who may be eligible?

This study is looking for female participants who have been diagnosed with anorexia nervosa. There is no specific age range mentioned, so it's open to females of different ages who meet the other study criteria.

To find out if you can join, the study team will ask you some questions about your health and your diagnosis of anorexia nervosa. This is to make sure the study is a good fit for you and that taking part would be safe.

If you're interested, the best first step is to talk to your doctor or the study team. They can provide all the details and help you understand if you meet the requirements.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female?
Do you have a diagnosis of anorexia nervosa?
Are you interested in trying a new approach to treatment?
Are you able to attend regular appointments for checks and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be using an oestrogen patch which you would apply to your skin. The study team would teach you how to do this correctly. Throughout the study, you would attend regular visits where various assessments would be carried out. These assessments are designed to check your anxiety levels and specific symptoms of anorexia, often using questionnaires.

They might also include blood tests to measure certain hormones like cortisol, ghrelin, and thyroid hormones (T3, T4). Your weight would be monitored, and you might also do some tests to check your thinking and memory skills. You would also complete questionnaires about your general well-being.

The total duration of your participation and how often you'd need to visit would be explained fully by the study team. They would make sure you understand the full schedule before you make any decisions.

Potential risks and benefits

Potential benefits of taking part could include gaining access to a new treatment approach that might help with your anxiety and anorexia symptoms, which you wouldn't otherwise receive. You would also be closely monitored by a healthcare team. However, as with any medication, there can be potential risks or side effects from using an oestrogen patch. These would be fully explained to you before you agree to participate, so you can make an informed decision. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Norway

Common questions

What is an oestrogen patch?

It's a small patch you stick on your skin that releases the hormone oestrogen into your body.

Why are they studying oestrogen for anorexia?

Researchers want to see if oestrogen might help reduce anxiety and other symptoms often experienced by people with anorexia.

Will this study cure my anorexia?

This is an early study to see if oestrogen might be a helpful part of treatment; it's not guaranteed to be a cure.

Will I have to take lots of tests?

You will have regular check-ups, which might include questionnaires, blood tests, and some thinking games to see how you're doing.

Can boys or men join this study?

No, this specific study is only looking for female participants who have anorexia nervosa.