Testosterone treatment for boys with Klinefelter syndrome during puberty
Klinefelter Syndrome - the Effect of Testosterone Treatment in Puberty. a Randomized, Double-blind Placebo-controlled Intervention Study: 'The TiPY Study'
This study tests if giving testosterone gel to boys aged 10-14 with Klinefelter syndrome can help improve their growth, body health, and brain development during puberty.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 10 Years to 14 Years |
| Sex | Male |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06294990 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of testosterone replacement therapy on boys aged 10-14 with Klinefelter syndrome (KS, 47,XXY). Participants will be randomly assigned to receive either testosterone gel or a placebo for two years. The study aims to assess how testosterone treatment influences body fat, metabolism, growth, bone health, and neurocognitive development. The findings could provide critical insights into the management of KS during a crucial developmental period.
Who should consider this trial
Good fit: Ideal candidates are boys aged 10-14 diagnosed with Klinefelter syndrome and exhibiting specific hormonal profiles.
Not a fit: Patients with contraindications to testosterone treatment or those currently participating in other clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve health outcomes and quality of life for boys with Klinefelter syndrome.
How similar studies have performed: While testosterone treatment in puberty for Klinefelter syndrome has been debated, this study aims to provide much-needed evidence, as similar approaches have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Lise Aksglaede, MD — Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
- Study coordinator: Lise Aksglaede, MD
- Email: lise.aksglaede@regionh.dk
- Phone: +45 35455064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.