Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Short-term changes in cardiovascular risk determinants after temporarily stopping gender-affirming hormone therapy in older transgender women - a pilot study

This research study is for older transgender women who have been taking gender-affirming hormone therapy for a while. The main goal is to see what happens to their heart health and general well-being if they temporarily stop their hormone treatment. Researchers will measure things like blood pressure, cholesterol levels, weight, and also ask about mood, sleep, and how they feel about their body. They will be looking at short-term changes to understand the impact of pausing hormone therapy before restarting it. This helps healthcare providers better understand the effects of long-term hormone use and breaks in treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Amsterdam UMC

Enrolment target

Start

15 Sep 2023

Transgender women using long-term gender-affirming hormone therapy

What is this study about?

This study is designed for transgender women who are a bit older and have been using gender-affirming hormone therapy (like oestrogen patches or gels) for a long time. The main idea is to see what happens to their body and how they feel if they take a short break from their hormones. Think of it as a careful check-up before and after this temporary pause.

The researchers are particularly interested in what they call 'heart health factors'. These include things your doctor usually checks, like your blood pressure, your heart rate, your weight, and different types of cholesterol in your blood. They also want to understand how this temporary break affects your overall well-being, such as your mood, sleep, body image, and general happiness. They'll also measure things like your strength and look at your hormone levels.

The reason this study is important is to learn more about the effects of long-term hormone therapy and what happens when it's temporarily stopped. This information can help transgender women and their doctors make more informed decisions about their treatment plans in the future, especially regarding heart health and quality of life.

Key takeaways

This study is for older transgender women using long-term hormone therapy.
It investigates short-term changes in heart health and well-being when hormones are temporarily stopped.
Measurements include blood pressure, cholesterol, weight, mood, and sleep.
Participation involves temporary hormone pause and regular check-ups.
The goal is to improve understanding of hormone therapy effects and breaks.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women who are 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate. The study is specifically for individuals who identify as female.

More specifically, they are looking for transgender women who are currently using gender-affirming hormone therapy and have been for some time. This means if you are a transgender woman receiving oestrogen treatment, you might be suitable for this study.

If you're unsure if you meet these description, it's always best to chat with your doctor or the study team.

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 18 years old or older?
Do you identify as a transgender woman?
Are you currently using gender-affirming hormone therapy (oestrogen)?
Have you been on hormone therapy for a long time?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would temporarily stop your gender-affirming hormone therapy. The specific type of oestrogen you are currently using, such as patches, gels, or tablets, will be recorded. Researchers will take various measurements, including your height, weight, blood pressure, and heart rate. You’ll also have blood samples taken to check your cholesterol levels and hormone levels. Beyond physical checks, you will be asked to fill out questionnaires about your mood, sleep, satisfaction with life, and how you feel about your body image.

They will also ask about your general health, any other medications you take, and your lifestyle, like smoking or how active you are. There will be multiple visits to the clinic to track these changes before, during, and after the temporary stop in hormone therapy, and when you restart your hormones. The exact number and timing of visits and the total duration aren't fully detailed here, but it involves regular check-ups over a short period.

Potential risks and benefits

Participating in this study might offer some potential benefits, as you would be closely monitored by healthcare professionals, and you would be contributing to valuable scientific knowledge that could help other transgender women in the future. However, temporarily stopping your hormone therapy could lead to some temporary changes in your body and mood, which might include hot flushes, mood changes, or other effects of reduced oestrogen. It's important to remember that 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.

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Unverified
Netherlands

Common questions

What kind of hormones are being studied?

The study focuses on common oestrogen treatments like patches (e.g., Estradiol Sandoz, Systen) and gels/sprays (e.g., Oestrogel, Lenzetto), as well as oestrogen tablets (e.g., Progynova).

Why would I temporarily stop my hormones for this study?

The study aims to understand what short-term changes happen to heart health and well-being when gender-affirming hormone therapy is paused, helping us learn more about long-term effects.

Will I restart my hormones after the study?

Yes, this study involves temporarily stopping hormones for a short period and then restarting them. The researchers will look at changes during and after this process.

What does 'heart health factors' mean?

This refers to things like your blood pressure, cholesterol levels (good and bad), triglycerides, weight, and heart rate – all indicators of your cardiovascular health.

Is this study only for older people?

While it's for older transgender women generally, specific older ages aren't defined, but the study is open to anyone 18 and over who fits the transgender woman criteria.