Study on Cardiovascular Risk Changes After Stopping and Restarting Estradiol in Older Transgender Women on Long-term Hormone Therapy

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What is this study about?

This clinical trial is focused on studying the effects of temporarily stopping and then restarting estradiol therapy in older transgender women who have been using long-term gender-affirming hormone therapy. Estradiol is a form of estrogen, a hormone that plays a key role in the development and maintenance of female characteristics. The study will involve different forms of estradiol treatment, including transdermal patches, gels, sprays, and tablets. The purpose of the study is to explore changes in cardiovascular risk factors, such as blood pressure and cholesterol levels, after stopping and then restarting estradiol therapy.

Participants will first stop their estradiol therapy for 12 weeks, during which time various health measurements will be taken. These measurements will include height, weight, body mass index (BMI), and blood tests to check cholesterol and other health indicators. After this period, participants will restart their estradiol therapy for another 12 weeks, and the same health measurements will be repeated. The study will also look at other aspects of well-being, such as life satisfaction, happiness, and sleep quality, using questionnaires. Additionally, information about lifestyle factors like smoking and physical activity will be collected.

The study aims to provide insights into how stopping and restarting estradiol therapy affects cardiovascular health and overall well-being in older transgender women. This research could help improve understanding of the long-term effects of gender-affirming hormone therapy and guide future treatment decisions. Participants will be monitored closely throughout the study to ensure their safety and well-being.

1 initial assessment

Upon joining the study, an initial assessment is conducted to gather baseline data. This includes measuring height, weight, body mass index (BMI), blood pressure, heart rate, and conducting laboratory tests to determine cholesterol levels and other cardiovascular risk factors.

Additional assessments include grip strength, general wellbeing, and lifestyle factors such as smoking, alcohol consumption, and physical activity.

2 stopping hormone therapy

The study involves temporarily stopping the use of estradiol therapy for a period of 12 weeks. This is to observe changes in cardiovascular risk factors and general wellbeing.

During this period, regular monitoring of health indicators continues, including blood pressure, heart rate, and laboratory measures.

3 monitoring during cessation

Throughout the 12-week cessation period, participants undergo regular check-ups to monitor any changes in cardiovascular risk factors and general wellbeing.

Participants complete questionnaires on life satisfaction, happiness, emotional distress, and sleep quality.

4 restarting hormone therapy

After the 12-week cessation period, estradiol therapy is restarted for another 12 weeks. The specific medications used include transdermal patches, gels, sprays, and oral tablets, with varying dosages.

The goal is to observe any changes in cardiovascular risk factors and general wellbeing after resuming therapy.

5 monitoring after resumption

During the 12 weeks of resumed therapy, participants continue to be monitored for changes in cardiovascular risk factors and general wellbeing.

Regular assessments and questionnaires are conducted to evaluate the impact of restarting estradiol therapy.

6 final assessment

At the end of the study, a final assessment is conducted to compare data from before, during, and after the cessation of estradiol therapy.

This includes a comprehensive evaluation of cardiovascular risk factors, general wellbeing, and lifestyle factors.

Who Can Join the Study?

Must be a transgender woman who has been using long-term gender-affirming hormone therapy.
Must be older than 54 years.
Must have been using gender-affirming hormone therapy (GHT) for at least 10 years. This therapy involves taking hormones to help align physical characteristics with gender identity.
Must currently be using GHT.
Must be receiving treatment at the Center of Expertise on Gender Dysphoria and have had a clinical appointment there within the last 3 years.
Must have undergone a gonadectomy, which means having had surgery such as a vaginoplasty or orchiectomy. A vaginoplasty is surgery to create a vagina, and an orchiectomy is surgery to remove the testicles.

Who Cannot Join the Study?

Individuals who are not transgender women using long-term gender-affirming hormone therapy cannot participate.
Individuals who are not within the specified age range for the study cannot participate.
Individuals who are not biologically female cannot participate.
Individuals who are considered part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Avfkyjcgt Usk	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	06.11.2023

Trial locations

Investigated drugs:

Estradiol is a form of estrogen, a hormone that plays a crucial role in the development and maintenance of female characteristics in the body. In this clinical trial, estradiol is used as part of gender-affirming hormone therapy for transgender women. The study aims to explore the effects on cardiovascular risk factors when estradiol therapy is temporarily stopped and then restarted.

Cardiovascular Disease – This condition involves the narrowing or blockage of blood vessels, which can lead to heart attacks, chest pain, or strokes. It often progresses as fatty deposits build up in the arteries, a process known as atherosclerosis. Over time, this can cause reduced blood flow to the heart and other parts of the body. Risk factors include high blood pressure, high cholesterol, smoking, and obesity. The disease can develop slowly over many years and may not show symptoms until significant damage has occurred. Regular monitoring of cardiovascular risk determinants such as blood pressure and cholesterol levels is important for managing the condition.

Trial ID:

2023-505143-39-00

Protocol code:

NL81591.018.22

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Cardiovascular Risk Changes After Stopping and Restarting Estradiol in Older Transgender Women on Long-term Hormone Therapy

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