Phase 4
Completed N=20
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
Klinefelter Syndrome
Source: ClinicalTrials.gov NCT02408445 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Change in Body Fat Percent Z-score — -0.12; 0.92 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. The Investigators know that older boys and men with Klinefelter syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. The Investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Fat Percent Z-score |
-0.12; 0.92 | — |
| SECONDARY Serum Luteinizing Hormone (LH) |
2.5; 2.5 | — |
| SECONDARY Serum Follicle Stimulating Hormone (FSH) |
1.8; 1.7 | — |
| SECONDARY Serum Total Testosterone |
181; 166 | — |
| SECONDARY Serum Inhibin B (INHB) |
244; 355 | — |
| SECONDARY Serum Anti-Mullerian Hormone (AMH) |
1377; 2208 | — |
| SECONDARY Leptin |
— | — |
| SECONDARY Change in Raw Score on the Alberta Infant Motor Scale |
10.5; 8.9 | — |
| SECONDARY Change in Score on the Movement Assessment of Infants (MAI) |
— | — |
| SECONDARY Change in Total Motor Standard Score on the Peabody Developmental Motor Scales 2 |
2.8; 2.0 | — |
| SECONDARY Change in Penile Length |
0.9; -0.3 | — |
| SECONDARY Change in Fat Free Mass |
1.4; 0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Male infants with 47,XXY karyotype
Exclusion Criteria
- Gestational age at birth 95% for gestational age
- History of thrombosis in a first degree relative
- Exposure to androgen therapy outside of the study protocol.
Data sourced from ClinicalTrials.gov (NCT02408445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.