Klinefelter Syndrome and Testosterone Treatment in Puberty

Plain-language summary

This study examines the effect of testosterone gel treatment compared with placebo in pubertal boys with 47,XXY Klinefelter syndrome. It enrolls children aged 10-14 with a diagnosis of 47,XXY Klinefelter syndrome who meet certain hormone criteria. The study is in Phase 4 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Recruiting

Sponsor

Lise Aksglæde

Intervention

Testosterone gel, Placebo

Start date

8/15/2024

Estimated completion

12/31/2029

Countries

Denmark

Related genes

Locations

• Copenhagen, Denmark

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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