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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Testosterone gel
DrugTwo years treatment with testosterone
Placebo
Other interventionTwo years treatment with placebo
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: TestosteroneActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in body fat mass
Evaluation of body fat percentage by whole body dual energy x-ray absorptiometry (DEXA) scan
Time frame
Baseline and 1 and two yearsSecondary outcomes
1
Pubertal development and virilization
Tanner genital (G) staging from G1 to G5. G1 is the prepubertal stage and G5 is the fully develloped stage.
Time frame
Every three months for two years2
Pubertal development and virilization
Tanner pubic hair (PH) staging from PH1 to PH6. PH1 is the prepubertal stage and PH6 is the fully develloped stage.
Time frame
Every three months for two years3
Pubertal development and virilization
Measurement of voice frequency using the app "Voice Analyst" (Speechtools Ltd.).
Time frame
Every three months for two years4
Pubertal development and virilization
Evaluation of testicular volume by palpation with orchidometer
Time frame
Every three months for two yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lise Aksglæde
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Source ClinicalTrials.gov