Phase 4
N=20
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
Klinefelter Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02408445 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change in Body Fat Percent Z-score — -0.12; 0.92 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- testosterone cypionate 200mg/ml (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- Male
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2018
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 | — |
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.
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.