RecruitingRare disease

Study on Testosterone and Isopropyl Myristate 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 is focused on studying the effects of Testosterone Replacement Therapy (TRT) 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 aims to understand how TRT, when used alongside estrogen replacement therapy, impacts different aspects of health, including hormone levels, heart health, brain function, and overall physical well-being.

The treatment being tested is a transdermal gel called Androgel, which contains testosterone. This gel is applied to the skin, allowing the testosterone to be absorbed into the body. The study will also involve other substances like Isopropyl Myristate, Carbomer 980, Sodium Hydroxide, and Ethanol (96 per cent), which are used in the formulation of the gel. Some participants will receive a placebo to compare the effects of the actual treatment.

Participants in the study will use the treatment for up to 12 months. Throughout the study, various health parameters will be monitored, such as body composition, quality of life, and physical activity levels. The goal is to gather comprehensive data on how TRT affects women with Turner Syndrome, providing insights into its potential benefits and any side effects. This research could help improve treatment options for women with this condition in the future.

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
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to evaluate the effects of testosterone replacement therapy in women with Turner Syndrome.
Step 2
Initial assessment
An initial assessment will be conducted to gather baseline data. This includes a DXA-scan to measure body composition, such as bone mass, fat mass, and muscle mass. Measurements of abdominal circumference and weight will also be taken.
Step 3
Medication administration
You will begin using a transdermal gel containing testosterone. The gel is applied to the skin, allowing the medication to be absorbed into the body. The dosage and frequency will be specified by the study team.
Step 4
Ongoing monitoring
Throughout the study, regular monitoring will occur to assess changes in various health parameters. This includes quality of life, inflammatory markers, sexual function, hormone levels, blood volume, and other metabolic and physiological measures.
Step 5
Follow-up assessments
Follow-up assessments will be conducted at specified intervals to track progress and any changes in health status. These assessments will include repeated DXA-scans and other evaluations as necessary.
Step 6
Completion of the study
Upon completion of the study, a final assessment will be conducted to gather end-of-study data. This will help determine the overall effects of the therapy on your health.

Who can join the trial?

5 criteria

Must have Turner Syndrome (all types).
Must be between the ages of 18 and 50.
Must be currently receiving estrogen replacement therapy (a treatment to replace estrogen hormones).
Must be able to speak Danish.
Must be female.

Who cannot join the trial?

4 criteria

Patients who do not have Turner Syndrome cannot participate.
Only women can participate; men are not eligible.
Participants must be within a specific age range as defined by the study.
Individuals who are part of a vulnerable population are not eligible. This means people who might need special protection or care.

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Verified sites

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Verified
Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Testosterone Replacement Therapy (TRT) is a treatment used to increase testosterone levels in the body. In this clinical trial, it is being used as a supplement to Estrogen Replacement Therapy (ERT) for women with Turner Syndrome. The goal is to study how this therapy affects various aspects of health, including hormone levels, heart health, physical functions, brain functions, and genetic factors. The testosterone is delivered through the skin using a patch, which allows the hormone to enter the bloodstream gradually. This method is chosen to mimic the natural release of testosterone in the body.

What is already known about the treatment

Testosterone Replacement Therapy (TRT) – This medication is administered through the skin using a patch or gel, known as transdermal application. It is currently being studied for its effects on women with Turner Syndrome, focusing on various health aspects like hormone levels, heart health, body functions, brain function, and genetic factors. The main use of TRT in this context is to supplement existing estrogen replacement therapy (ERT) to help manage symptoms associated with Turner Syndrome. At the molecular level, testosterone works by binding to specific receptors in the body, influencing the expression of certain genes and helping to regulate various bodily functions. It is classified as a hormone replacement therapy.

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. The syndrome can affect physical appearance, with common features including a webbed neck, low-set ears, and a broad chest. As individuals age, they may face challenges related to bone health and cardiovascular function. The progression of Turner Syndrome varies widely among individuals, with some experiencing more severe symptoms than others.