Testosterone Treatment for Boys with Klinefelter Syndrome: A Study on Body Composition Changes During Puberty

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What is this study about?

This clinical trial is focused on studying Klinefelter syndrome, a genetic condition that affects males and is characterized by an extra X chromosome. The study will explore the effects of testosterone treatment during puberty in boys with this condition. The treatment involves using a gel called AndroGel 1%, which is applied to the skin. Some participants will receive a placebo, which is a gel that looks the same but does not contain the active ingredient.

The purpose of the study is to evaluate how two years of testosterone replacement therapy can affect body composition, which includes changes in body fat and muscle mass. Participants will be monitored for various health indicators, including growth and development during puberty, hormone levels, and bone health. The study will also assess other factors such as cholesterol levels, blood sugar, and overall physical development.

Throughout the study, participants will undergo regular health assessments, including scans and blood tests, to track changes in their bodies. The study aims to provide valuable insights into how testosterone treatment can benefit boys with Klinefelter syndrome during their critical developmental years. The trial is expected to continue until the end of 2029.

1 joining the study

Upon joining the study, participation is confirmed for boys aged 10-14 years with Klinefelter syndrome, verified by specific genetic tests. Consent from parents is required.

2 treatment initiation

The study involves the use of AndroGel 1%, a gel containing testosterone, applied to the skin. A placebo gel, identical in appearance, is also used for comparison. The treatment is administered daily for a duration of two years.

3 monitoring body composition

Body composition is evaluated using a DEXA scan, which measures body fat percentage, the ratio between different types of fat, and muscle mass.

4 pubertal development assessment

Pubertal development is monitored through Tanner staging, voice frequency analysis, and hormone level measurements in the blood.

5 physical measurements

Measurements include height, weight, sitting height, head circumference, and arm span. Blood tests are conducted to measure specific growth factors and evaluate bone age through x-rays.

6 metabolic health evaluation

Blood tests are performed to assess cholesterol levels, triglycerides, glucose, insulin, and other metabolic markers.

7 neuropsychological assessment

A neuropsychological assessment is conducted before and after the two-year treatment period to evaluate cognitive and psychological changes.

8 bone health monitoring

Bone health is evaluated using DEXA scans and various blood markers related to bone turnover and health.

9 strength and heart health evaluation

Grip strength is measured, and an electrocardiogram (ECG) is performed to evaluate heart health.

10 optional semen analysis

If the participant is able and willing, a semen sample may be collected to assess semen quality.

Who Can Join the Study?

Boys with Klinefelter syndrome. This is a condition where a boy has an extra X chromosome, making it 47,XXY instead of the usual 46,XY.
Age between 10 and 14 years old.
LH (Luteinizing Hormone) levels must be higher than +2 standard deviations. This means the hormone level is higher than what is typically expected for boys of the same age. This is measured using a very sensitive test.
Free T (Free Testosterone) levels must be less than +2 standard deviations. This means the testosterone level is lower than what is typically expected for boys of the same age.
Parents must provide signed consent for their child to participate in the study.

Who Cannot Join the Study?

Individuals who do not have Klinefelter syndrome. This is a condition where a male is born with an extra X chromosome.
Individuals who are not male. The study is only for males.
Individuals who are not in the age range specified for the study. The study is for a specific age group.
Individuals who are not considered part of a vulnerable population. The study is for those who are considered vulnerable.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Aepjan Uqnzmebynk Heyaewci	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	21.08.2023

Trial locations

Investigated drugs:

Testosterone

Testosterone is a hormone therapy used in this study to evaluate its effects on boys with Klinefelter syndrome during puberty. The therapy aims to assess changes in body composition over a two-year period.

Investigated diseases:

Klinefelter's syndrome

Klinefelter Syndrome – Klinefelter syndrome is a genetic condition that affects males, typically caused by an extra X chromosome, resulting in a 47,XXY karyotype. This condition can lead to physical, developmental, and hormonal changes, often becoming noticeable during puberty. Common features include reduced muscle mass, less facial and body hair, and enlarged breast tissue. Individuals may also experience learning difficulties and challenges with speech and language development. The syndrome can affect fertility, with many affected individuals having low testosterone levels and reduced sperm production. The progression of symptoms can vary widely among individuals, with some experiencing more pronounced effects than others.

Trial ID:

2023-505854-16-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Testosterone Treatment for Boys with Klinefelter Syndrome: A Study on Body Composition Changes During Puberty

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