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

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What is this study about?

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Atkmlb Ulxifskhpm Hlnyjtqv	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.01.2022

Trial locations

Investigated drugs:

Estradiol

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.

Investigated diseases:

Turner's syndrome

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.

Trial ID:

2024-518557-42-00

NCT ID:

NCT06544473

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?