RecruitingRare disease

Study on Long-Term Effects of Oral and Transdermal Estradiol Therapy in Women with Turner Syndrome

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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 in women with Turner syndrome. Turner syndrome is a condition that affects females, where one of the X chromosomes is missing or partially missing, leading to various developmental issues. The study will compare two forms of estrogen therapy: an oral tablet called Estrofem and a transdermal gel known as Divigel. Both treatments contain the active substance estradiol, which is a form of estrogen, a hormone important for female development and health.

The purpose of the study is to understand the long-term effects of these two types of estrogen therapy on various health aspects in women with Turner syndrome. Participants will receive either the oral or transdermal form of estrogen therapy. The study will look at how these treatments affect different areas such as hormone levels, heart health, and overall physical well-being. The study will also assess the risk factors related to blood clots and other cardiovascular issues.

Throughout the study, participants will undergo various tests to monitor changes in their body composition, blood values, heart function, muscle strength, and bone density. Additionally, participants will be asked to report on their quality of life and how they feel about the treatments after six months of using each form of therapy. The study aims to provide valuable insights into the best ways to manage Turner syndrome with estrogen therapy.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment will be conducted. This includes a review of medical history and a physical examination to ensure eligibility based on the criteria for Turner syndrome.
Blood tests will be performed to establish baseline values for metabolism, endocrinology, cardiovascular function, and coagulation.
Step 2
Washout period
A washout period will occur where current estrogen treatments are paused. This allows for accurate assessment of baseline health conditions without the influence of previous treatments.
Step 3
Oral estrogen therapy
Participants will begin taking Estrofem, a film-coated tablet containing estradiol, administered orally.
The dosage and frequency will be determined by the study team, and this phase will last for six months.
Step 4
Mid-study assessment
After six months of oral therapy, another assessment will be conducted. This includes blood tests, body composition analysis, cardiovascular status monitoring, and muscle strength tests.
Participants will also complete self-reported quality of life questionnaires.
Step 5
Transdermal estrogen therapy
Participants will switch to Divigel, a gel containing estradiol, applied to the skin.
The dosage and frequency will be determined by the study team, and this phase will also last for six months.
Step 6
Final assessment
At the end of the transdermal therapy phase, a final assessment will be conducted. This includes the same tests and questionnaires as the mid-study assessment.
The study aims to compare the effects of oral versus transdermal estrogen therapy on various health parameters.

Who can join the trial?

9 criteria

Must have a diagnosis of Turner syndrome, which is a genetic condition affecting females.
Must be between the ages of 18 and 50 years old.
Must already be receiving estrogen treatment, which is a hormone therapy.
Must be female.
For healthy controls (participants without Turner syndrome):
Must be previously healthy, meaning no significant past illnesses.
Must not be taking any medication.
Must not be using any form of contraceptive pills.
Must not have any mental or psychiatric disorders.

Who cannot join the trial?

4 criteria

Men cannot participate in the study. Only women are eligible.
Individuals who do not have Turner syndrome cannot participate. Turner syndrome is a condition that affects only females and is related to the X chromosome.
Participants must be within a specific age range, which is not specified here.
Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

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Verified sites

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Aarhus University Hospital
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Aarhus, Denmark

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Investigated drugs

Oral Estrogen Replacement Therapy (ERT)
is a treatment that involves taking estrogen in pill form. Estrogen is a hormone that plays a crucial role in the development and regulation of the female reproductive system and secondary sexual characteristics. In this clinical trial, oral ERT is used to help women with Turner syndrome, a condition where a female is partly or completely missing an X chromosome, to manage symptoms related to low estrogen levels. The therapy aims to improve various health aspects, including bone health, cardiovascular function, and overall well-being.
Transdermal Estrogen Replacement Therapy (ERT)
is another form of estrogen treatment, but instead of taking it as a pill, the hormone is delivered through the skin using patches, gels, or creams. This method allows estrogen to enter the bloodstream directly, which can be beneficial for women with Turner syndrome. The transdermal approach is used in this trial to compare its effects with oral ERT on health factors such as heart health, metabolism, and hormone levels. The goal is to determine which method is more effective or has fewer side effects for women with this condition.

Estradiol

What is already known about the treatment

Estrogen Replacement Therapy (ERT) – Estrogen Replacement Therapy can be administered either orally or through the skin using patches, known as transdermal application. This therapy is currently being studied for its effects on women with Turner syndrome, a condition that affects development in females. The main goal of ERT is to provide the body with estrogen, a hormone that is typically low in individuals with Turner syndrome, to help manage symptoms and reduce risks related to heart and bone health. At the molecular level, estrogen works by binding to specific receptors in the body, influencing various physiological processes. ERT is classified as a hormone replacement therapy and is being evaluated for its long-term effects on health, particularly in terms of endocrine and cardiovascular outcomes.

Investigated diseases

Turner syndrome – Turner syndrome is a genetic disorder that affects females, characterized by the partial or complete absence of one of the X chromosomes. This condition can lead to a variety of developmental issues, including short stature and the lack of ovarian development, which often results in infertility. Individuals with Turner syndrome may also experience heart defects, kidney problems, and hearing loss. The syndrome can affect the skeletal system, leading to a higher risk of osteoporosis. Additionally, there may be challenges with spatial-temporal processing and nonverbal memory. Hormonal imbalances are common, impacting growth and development.