Testosterone Effects on Short-term Physical, Hormonal, and Neurodevelopmental Outcomes (TESTO) in Infants With 47,XXY
Primary result · Change in percent fat mass z-scores; Alberta Infant Motor ScalesResult — go to the resultBetween-group difference in change in percent fat mass z-scores −0.57 95% CI −1.1 to −0.06Authors' conclusion
In this double-blind randomized controlled trial in infants with XXY, testosterone injections resulted in physical effects attributable to systemic androgen exposure; however, this dose suppressed the hypothalamic-pituitary-gonadal axis. Neurodevelopment outcomes were not impacted by treatment. These results do not support routine testosterone treatment in infants with XXY; however, long-term follow-up on physical health, neurodevelopment, and testicular function is needed.
Study context
- Population
- Infants aged 30 to 90 days with prenatally identified, nonmosaic 47,XXY (Klinefelter syndrome), US tertiary care paediatric hospital, 2017–2021
- Participants
- 71 infants
- Comparison
- Testosterone cypionate injections vs control
- Primary endpoint
- Change in percent fat mass z-scores and change in total composite percentile on Alberta Infant Motor Scales
- Follow-up
- Baseline to 12 weeks
Methodological detailsdouble-blind, single tertiary care paediatric hospital
- Double-blind
- Single tertiary care paediatric hospital
Primary result
As reported in the abstract
Change in percent fat mass z-scores; Alberta Infant Motor Scales
Between-group difference in change in percent fat mass z-scores
−0.57
95% CI −1.1 to −0.06
P = 0.03
Testosteronevs Control
between-group difference in change in percent fat mass z-scores −0.57 (95% CI −1.1 to −0.06); P = 0.03
- No significant group differences in short-term motor, cognitive, or language outcomes
- P > 0.15 for all
Further findings
| Outcome | Testosterone | Control | P value |
|---|---|---|---|
| Increase in lean massGreater increase with Testosterone | 1.5 ± 0.4 kg | 1.2 ± 0.4 | P = 0.001 |
Safety
- Testosterone suppressed gonadotropins and inhibin B
- P < 0.001 for all
Original publication
Testosterone Effects on Short-term Physical, Hormonal, and Neurodevelopmental Outcomes (TESTO) in Infants With 47,XXY. J Clin Endocrinol Metab. Published 3 April 2025. doi:10.
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