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Recruiting Phase 4

Klinefelter Syndrome and Testosterone Treatment in Puberty

NCT06294990 · tracked via the Priya Life Science Denmark tracker
Sponsor
Lise Aksglæde
Phase
Phase 4
Started
2024-08-15
Last updated
2025-02-19

Condition(s) studied

Klinefelter Syndrome

Investigational drug(s) / intervention(s)

Testosterone gel →Placebo

Testosterone gel: Two years treatment with testosterone

Placebo: Two years treatment with placebo

Study summary

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.

Participants will be randomized to two years treatment with testosterone or placebo.

Eligibility

Sex
MALE
Min age
10 Years
Max age
14 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Changes in body fat mass — Baseline and 1 and two years
    Evaluation of body fat percentage by whole body dual energy x-ray absorptiometry (DEXA) scan

Trial sites (1)

FacilityCityRegionStatus
Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06294990 on ClinicalTrials.gov ↗ ← All trials in Denmark