RecruitingRare disease

Study on Estrogen Treatment (Oral vs. Transdermal) for Women with Turner Syndrome

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying Turner syndrome, a condition that affects females and is characterized by the absence of all or part of a second sex chromosome. The study aims to compare the effectiveness of two different forms of estradiol treatment, which is a type of estrogen hormone therapy. The treatments being compared are Estrofem, a film-coated tablet taken orally, and Divigel, a gel applied to the skin. Both treatments contain the active substance estradiol, which is used to help manage symptoms associated with Turner syndrome.

The purpose of the study is to determine if the oral and transdermal (through the skin) forms of estradiol are equally effective in treating women with Turner syndrome. Participants in the study will receive either the oral or transdermal treatment and will be monitored for changes in hormone levels, specifically luteinizing hormone and follicle-stimulating hormone, which are important indicators of how the body is responding to the treatment. The study will help researchers understand if both forms of treatment provide the same benefits.

Participants will be involved in the study for a period of up to 14 days, during which they will receive one of the two treatments. The study will not only help in understanding the effectiveness of these treatments but also provide insights into the best way to manage Turner syndrome using hormone therapy. The findings from this study could lead to improved treatment options for women with this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, a detailed explanation of the study is provided, including the purpose and procedures involved.
A medical history review and a physical examination are conducted to ensure eligibility based on the study criteria.
Step 2
Medication administration
Participants are assigned to one of two groups: one receiving oral estradiol and the other receiving transdermal estradiol.
The oral estradiol is administered as Estrofem, film-coated tablets, taken once daily.
The transdermal estradiol is administered as Divigel 1 mg gel, applied to the skin once daily.
Step 3
Regular follow-up visits
Regular follow-up visits are scheduled to monitor health and response to the treatment. These visits include blood tests to measure hormone levels.
Participants are asked about any side effects or changes in health status.
Step 4
Final assessment
At the end of the study period, a final assessment is conducted. This includes a comprehensive review of health and hormone levels.
Participants are provided with information about the study's findings and any next steps regarding their treatment.

Who can join the trial?

8 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 if participating as a healthy control.
Must be previously healthy if participating as a healthy control.
Must not be receiving any medication if participating as a healthy control.
Must not be using any kind of contraceptive pills if participating as a healthy control.
Must not have any mental or psychiatric disorders if participating as a healthy control.

Who cannot join the trial?

4 criteria

Patients who do not have Turner syndrome cannot participate.
Only females are allowed to participate; males cannot join the study.
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 like children, pregnant women, or those unable to give consent.

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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

Estradiol (Oral)
is a form of estrogen, a female sex hormone that is important for many processes in the body. In this trial, it is taken by mouth to help study its effects on various body functions in individuals with Turner Syndrome. The goal is to understand how this form of estradiol influences certain markers in the body that depend on estrogen.
Estradiol (Transdermal)
is another form of estrogen therapy, but instead of being taken by mouth, it is applied to the skin. This method allows the hormone to be absorbed directly into the bloodstream. In this trial, researchers are comparing how this form of estradiol affects the body compared to the oral form, focusing on specific markers that are influenced by estrogen.

Estradiol

What is already known about the treatment

Estradiol (oral administration)
This medication is taken by mouth and is currently being studied for its effects in treating Turner syndrome, a condition affecting females that can cause various developmental issues. Estradiol is a form of estrogen, a hormone that plays a crucial role in female development and reproductive health. It works by binding to estrogen receptors in the body, helping to regulate various bodily functions. Estradiol is classified as an estrogen hormone and is being evaluated to determine its effectiveness compared to other forms of administration.
Estradiol (transdermal administration)
This medication is applied to the skin in the form of a patch and is also being studied for its use in managing Turner syndrome. Like its oral counterpart, transdermal estradiol delivers estrogen directly into the bloodstream, which may offer different benefits or effects. It functions by interacting with estrogen receptors, influencing various physiological processes. This form of estradiol is also classified as an estrogen hormone, and the study aims to compare its potency and effects with the oral form.

Investigated diseases

Turner syndrome – Turner syndrome is a genetic disorder that affects females, characterized by the partial or complete absence of one of the two 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 certain learning disabilities. As they grow, affected individuals may have a webbed neck, low-set ears, and a broad chest with widely spaced nipples. The progression of Turner syndrome varies widely among individuals, with some experiencing more severe symptoms than others. Hormonal imbalances are common, and puberty may be delayed or incomplete.