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AuthorisedTherapeutic use (Phase IV)Interventional

Early mental response to hormonal treatment in transgender men - The EMRE Study

The EMRE Study is looking into the early mental health experiences of transgender men who are starting hormone treatment. It's designed for adults aged 18 and over who have been diagnosed with gender dysphoria. The study aims to understand how these hormonal changes affect their feelings and overall well-being in the initial stages. By collecting information on their mental response, researchers hope to gain valuable insights to help improve care and support for transgender men going through this significant life change. This is a research study, not a new treatment, and helps us learn more about existing medical pathways.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Karolinska University Hospital
Enrolment target
70
Start
01 Oct 2024

What is this study about?

The EMRE Study is all about understanding how transgender men feel in their minds and emotions when they first begin taking hormones, such as testosterone. When someone starts this kind of treatment, it's a big step that can bring about many changes, both physically and how they feel inside. This study wants to carefully observe and learn about these early mental and emotional responses.

Researchers hope that by gathering this information, they can better understand the experiences of transgender men as they transition. This knowledge is really important because it can help doctors and healthcare teams provide even better support and care during this significant time. Imagine it like a journey: the study wants to map out the emotional landscape of the beginning of that journey.

This isn't about testing a new medicine; it's about learning more about the effects of treatments that are already in use. It's a 'Phase IV' study, which means it helps us understand more about existing, approved medical approaches. The goal is ultimately to improve the well-being and health journey for transgender men.

Key takeaways

  • The study explores mental and emotional responses after starting hormone treatment.
  • It's for transgender men aged 18 and over with gender dysphoria.
  • It aims to improve future care and support for transgender individuals.
  • You'll continue your regular hormone treatment while participating.
  • Your well-being is monitored, and you can withdraw at any time.

Who may be eligible?

This study is looking for volunteers who are assigned female at birth but identify as male, commonly known as transgender men. You need to be at least 18 years old to take part; there's no upper age limit.

To be considered, you also need to have received a diagnosis of gender dysphoria. This is a medical term used when someone experiences discomfort or distress because their assigned sex at birth is different from the gender they know themselves to be. You should also be at the stage where you are just starting or have recently started hormone treatment.

If you're under 18, assigned male at birth, or haven't been diagnosed with gender dysphoria, this particular study wouldn't be the right fit for you.

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.

  1. Are you 18 years old or older?
  2. Do you identify as a man (assigned female at birth)?
  3. Have you been diagnosed with gender dysphoria?
  4. Are you currently starting or have you recently started hormone treatment?
  5. Are you able to attend study visits or complete questionnaires regularly?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the EMRE Study, it would involve a series of visits or check-ins over a period of time. During these, you might be asked to complete questionnaires about your feelings and mental well-being, or have discussions with healthcare professionals about your experiences. You would continue to take your prescribed hormone treatment as advised by your doctor, as the study is observing the effects of this ongoing treatment, not introducing a new one.

The study would closely follow your journey as you adjust to the early stages of hormone therapy. The specific number of visits, assessments, and the full duration of your participation would be clearly explained to you before you agree to join. You wouldn't be asked to change your current medication plan; the study simply observes how you respond to your existing treatment.

Potential risks and benefits

Taking part in this study may offer you the benefit of contributing to a better understanding of the transgender experience, potentially helping others in the future. You'll also receive ongoing monitoring of your mental well-being during your hormone therapy. There are no direct medical risks from participating in the study itself, as you would continue your hormone treatment as prescribed by your own doctor. However, as with any medical process, hormone treatment always carries its own known side effects, which your doctor would have discussed with you. You are always free to leave 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
    Sweden

Common questions

What is gender dysphoria?

Gender dysphoria is when a person feels a strong sense of unease or distress because their assigned sex at birth doesn't match their inner sense of gender.

Is this study testing a new drug?

No, this study is not testing a new drug. It's looking at how people feel when they start hormone treatments that are already regularly used.

Will I have to stop my hormones if I join?

Absolutely not. You will continue taking your hormone treatment exactly as your own doctor has prescribed it.

How long will I need to be in the study?

The exact length of time will be explained in detail if you are considering joining, but it focuses on your early response to hormones.

Can I leave the study at any time?

Yes, you are completely free to leave the study at any point, and this will not affect your medical care in any way.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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