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RECRUITING
NCT06294990
PHASE4

Klinefelter Syndrome and Testosterone Treatment in Puberty

Sponsor: Lise Aksglæde

View on ClinicalTrials.gov

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.

Official title: Klinefelter Syndrome - the Effect of Testosterone Treatment in Puberty. a Randomized, Double-blind Placebo-controlled Intervention Study: 'The TiPY Study'

Key Details

Gender

MALE

Age Range

10 Years - 14 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2024-08-15

Completion Date

2029-12-31

Last Updated

2025-02-19

Healthy Volunteers

No

Interventions

DRUG

Testosterone gel

Two years treatment with testosterone

OTHER

Placebo

Two years treatment with placebo

Locations (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark