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Klinefelter Syndrome and Testosterone Treatment in Puberty

NCT06294990 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-02-19

No results posted yet for this 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.

Conditions

  • Klinefelter Syndrome

Interventions

DRUG

Testosterone gel

Two years treatment with testosterone

OTHER

Placebo

Two years treatment with placebo

Sponsors & Collaborators

  • Lise Aksglæde

    lead OTHER

Principal Investigators

  • Lise Aksglaede, MD · Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06294990 on ClinicalTrials.gov