Klinefelter Syndrome and Testosterone Treatment in Puberty (NCT06294990) | Clinical Trial Compass
RecruitingPhase 4
Klinefelter Syndrome and Testosterone Treatment in Puberty
Denmark32 participantsStarted 2024-08-15
Plain-language 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.
Who can participate
Age range
10 Years – 14 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 4 trial, testosterone treatment is already approved — so what does my doctor think we'd learn from this study that isn't already known, and how might that information benefit my son's care?
2The trial is specifically measuring changes in body fat mass during puberty — does my doctor think my son's current body composition makes him a good candidate to discuss this study with the research team?
3Since the trial involves testosterone treatment during puberty, what are the known risks of starting testosterone at my son's current age and stage of development, and how would those be monitored if we were to talk to the team about enrolling?
4Would my son need to delay or change any standard testosterone therapy he might otherwise start soon in order to participate in this study, and could that affect his development?
5Are there standard-of-care approaches to managing Klinefelter syndrome during puberty that my doctor would recommend considering before or instead of discussing this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.