Phase 2
N=93
Androgen Effect on Klinefelter Syndrome Motor Outcome
Klinefelter Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00348946 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Motor Function/Strength — 86; 81; 92; 89 score on a scale — p=0.005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- androgen oxandrolone (Drug); placebo (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- Male
- Sponsor
- Thomas Jefferson University
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Motor Function/Strength |
86; 81; 92; 89; 88; 85 | 0.005 sig |
| SECONDARY Cognitive Function and Language |
96; 94; 92; 90; 102; 101 | 0.44 |
| SECONDARY Working Memory/Attention |
96; 92; 95; 91; 99; 94 | 0.23 |
| SECONDARY Psychosocial and Behavior Domain |
105; 100 | 0.15 |
| SECONDARY Psychosocial and Behavior Domain |
105; 100 | 0.15 |
Summary
The purpose of this study is to evaluate the effects of low-dose androgen on the motor and cognitive development of boys with Klinefelter syndrome.
Eligibility Criteria
Inclusion Criteria
- Karyotype diagnosis of Klinefelter syndrome
- Chronological age of 4-12 years
- No treatment with androgen in the past year
Exclusion Criteria
- Major liver, kidney or other systemic disease
- Variant karyotypes including 47,XYY males
- Evidence of spontaneous onset of puberty, defined as testicular size > 4ml
Data sourced from ClinicalTrials.gov (NCT00348946). 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.