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New treatment option for Klinefelter Syndrome
Official title Klinefelter Syndrome and Testosterone Treatment in Puberty
ClinicalTrials.gov ID: NCT06294990
What this study is testing
What is Testosterone gel?
Testosterone gel is an investigational medicine, being studied as a potential treatment for klinefelter syndrome.
Also referred to as Testosterone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this randomized clinical trial is to study the effect of testosterone replacement therapy during puberty in boys with Klinefelter syndrome (KS, 47,XXY). The main questions to answer are how treatment with testosterone will affect body fat mass, lipid and glucose metabolism, growth and body proportions, bone mineralization as well as effects on neurocognitive development and emotional and social difficulties.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 14, men only
You may be able to join if
- 47,XXY Klinefelter syndrome
- Age 10-14 years at inclusion
- Luteinizing Hormone \> +2 standard deviations (SD) by ultrasensitive luteinizing hormone assay
- Free Testosterone\<+2 standard deviations
- Signed consent from parents
You likely can't join if
- Previous or ongoing T treatment except for TRT because of micropenis
- Contraindications to testosterone treatment known hypersensitivity to testosterone or to any other constituent of the gel known or suspected...
- Participation in any other clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 10 years to 14 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.