Testosterone treatment for boys with Klinefelter syndrome during puberty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of testosterone replacement therapy on boys aged 10-14 with Klinefelter syndrome (KS, 47,XXY). Participants will be randomly assigned to receive either testosterone gel or a placebo for two years. The study aims to assess how testosterone treatment influences body fat, metabolism, growth, bone health, and neurocognitive development. The findings could provide critical insights into the management of KS during a crucial developmental period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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 prostatic cancer or breast carcinoma
* Participation in any other clinical trial

Where it's running

• Copenhagen University Hospital, Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Lise Aksglaede, MD — Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
• Study coordinator: Lise Aksglaede, MD
• Email: lise.aksglaede@regionh.dk
• Phone: +45 35455064

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Balancing sex hormones to improve health in men with Klinefelter syndrome

  This study is testing if a new hormone treatment can improve health and sperm production in men with Klinefelter syndrome by balancing their sex hormones and looking at weight loss effects.

  Recruiting Phase 3 University of Lausanne Hospitals · Lausanne · NCT05586802

• Evaluating thyroid function and structure in Klinefelter syndrome

  This study is testing how well the thyroid works and looks in people with Klinefelter syndrome compared to healthy individuals and those with a specific thyroid condition.

  Recruiting University of Roma La Sapienza · Roma · NCT05581147

• Research on health and development in infants with sex chromosome trisomy

  This study looks at the health and development of infants with sex chromosome trisomies, like Klinefelter syndrome, to see how they grow and what early signs can help doctors provide better care.

  Recruiting at 2 sites University of Colorado, Denver · Aurora, Colorado and 1 other locations · NCT03396562

• Observing the health management of patients with rare genetic syndromes

  This study looks at how patients with rare genetic syndromes like Prader-Willi and Klinefelter manage their health as they move from children's care to adult care to see what support they need.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT04463316

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.