N/A
N=48
Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome
Klinefelter Syndrome · XXY Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01585831 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Change From Baseline on the Delis-Kaplan Executive Function System — -0.72; 1.29; 1.28; 0.65 Scaled scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Testosterone gel 1% (Drug); Placebo gel (Drug)
- Age
- Pediatric, Adult · 8+ yrs
- Sex
- Male
- Sponsor
- University of Colorado, Denver
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on the Delis-Kaplan Executive Function System |
-0.72; 1.29; 1.28; 0.65; 0.75; 0.76 | — |
| PRIMARY Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2 |
39.92; 35.52; 41.34; 37.17 | — |
| PRIMARY Change From Baseline on the Conners Parent Rating Scales: DSM Attention |
64.2; 62.8; 58.1; 59.3 | — |
| PRIMARY Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity |
60.7; 57.2; 53.4; 54.4 | — |
| PRIMARY Change From Baseline on the Conners Parent Rating Scales: Anxiety |
59.7; 62.2; 54.0; 62.8 | — |
| PRIMARY Change From Baseline on the Conners Parent Rating Scales: Social Skills |
64.3; 66.4; 62.7; 63.2 | — |
| PRIMARY Change From Baseline on the Conners Parent Rating Scales: Emotional Lability |
59.4; 61.3; 57.3; 54.4 | — |
| SECONDARY Change From Baseline on the Vineland Adaptive Behavior Scales - 2nd Edition |
78.7; 75.8; 82.2; 78.4 | — |
| SECONDARY Change From Baseline on the Wechsler Intelligence Scale for Children - Fourth Edition |
86.8; 83.9; 88.7; 84.6 | — |
| SECONDARY Change From Baseline on the Comprehensive Test of Phonological Processing |
77.0; 78.1; 77.1; 77.4 | — |
Summary
The purpose of this study is to determine if testosterone replacement therapy leads to changes in psychological factors and/or motor skills in adolescent males with 47,XXY (also called Klinefelter syndrome). This study will also evaluate whether certain genetic factors of the X chromosome affect the psychological or motor features of XXY/Klinefelter syndrome.
Eligibility Criteria
Inclusion Criteria
- Males with 47,XXY
- Participants must be in early puberty (Tanner stage II-III)
- Age 8 - 18 will be considered, but eligibility will be determined by review of laboratory results, bone age X-ray, and physical examination to determine stage of puberty
- All racial and ethnic groups
Exclusion Criteria
- Other genetic variations of Klinefelter syndrome (48,XXXY, 48,XXYY, 49,XXXXY). The investigator has other studies for these groups and we encourage interested individuals with these disorders to contact us about other available studies.
- 47,XXY plus another genetic disorder
- Non-English speaking individuals (because the psychological tests are administered in English)
- Participants with a medical history of blood clotting problems, blindness, deafness, or cancer
Data sourced from ClinicalTrials.gov (NCT01585831). 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.