Klinefelter Syndrome and Testosterone Treatment in Puberty
ConditionKlinefelter Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age10-14
SponsorLise Aksglæde
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Testosterone gel
- Placebo
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lise Aksglæde
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Source ClinicalTrials.gov