Klinefelter Syndrome Clinical Trial
— TestoXXY/KSOfficial title:
Psychological and Motor Effects of Testosterone Therapy in Adolescents With XXY/Klinefelter Syndrome
Verified date | July 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 8 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Childrens Hospital Colorado | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Children's Hospital Colorado, Colorado Clinical & Translational Sciences Institute, National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline on the Delis-Kaplan Executive Function System | A collection of subtests from the Delis-Kaplan Executive Function System will be used to evaluate different domains of executive functions including planning, problem solving, fluency, inhibition, and working memory. Possible scaled scores range from 0-20 (mean of 10), with higher scores indicating better performance. The value of the change in scaled score from baseline is reported. | Visit 1 (baseline) and Visit 5 (1 year) | |
Primary | Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2 | This test evaluates many aspects of motor functioning including fine and gross motor skills, visual motor integration, motor planning, and motor coordination. Possible scores range from 20-80, with higher scores indicating a better outcome. | Visit 1 (baseline) and Visit 5 (1 year) | |
Primary | Change From Baseline on the Conners Parent Rating Scales: DSM Attention | This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100 (Mean T-score 50), with higher scores indicating a worse outcome. | Visit 1 (baseline) and Visit 5 (1 year) | |
Primary | Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity | This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100 (Mean T-score 50), with higher scores indicating a worse outcome. | Visit 1 (baseline) and Visit 5 (1 year) | |
Primary | Change From Baseline on the Conners Parent Rating Scales: Anxiety | This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100 (Mean T-score 50), with higher scores indicating a worse outcome. | Visit 1 (baseline) and Visit 5 (1 year) | |
Primary | Change From Baseline on the Conners Parent Rating Scales: Social Skills | This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100, with higher scores indicating a worse outcome. | Visit 1 (baseline) and Visit 5 (1 year) | |
Primary | Change From Baseline on the Conners Parent Rating Scales: Emotional Lability | This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability. The range of possible scores is 0 to 100, with higher scores indicating a worse outcome. | Visit 1 (baseline) and Visit 5 (1 year) | |
Secondary | Change From Baseline on the Vineland Adaptive Behavior Scales - 2nd Edition | The Vineland-2 is an interview evaluating adaptive skills in the areas of communication, daily living skills, social skills, and motor skills. Possible scores range from 20 to 160 (mean 100), with higher scores indicating a better outcome. | Visit 1 (baseline) and Visit 5 (1 year) | |
Secondary | Change From Baseline on the Wechsler Intelligence Scale for Children - Fourth Edition | This standardized assessment of cognitive functioning allows for evaluation of verbal and nonverbal cognitive skills, working memory, and processing speed. Possible full scale IQ scores range from 40-180 (mean 100), with higher scores indicating a better outcome. | Visit 1 (baseline) and Visit 5 (1 year) | |
Secondary | Change From Baseline on the Comprehensive Test of Phonological Processing | This standardized test evaluates reading and language skills. Possible scores range from 20-200 (Mean Standard Score 100), with higher scores indicating a better outcome. | Visit 1 (baseline) and Visit 5 (1 year) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03396562 -
The eXtroardinarY Babies Study: Natural History of Health and Neurodevelopment in Infants and Young Children With Sex Chromosome Trisomy
|
||
Completed |
NCT02526628 -
Thrombosis and Neurocognition in Klinefelter Syndrome
|
||
Completed |
NCT01690013 -
Life Quality and Health in Patients With Klinefelter Syndrome
|
N/A | |
Completed |
NCT01678261 -
X-chromosome Inactivation, Epigenetics and the Transcriptome
|
N/A | |
Completed |
NCT01918280 -
Fertility Preservation in Cases of Klinefelter Syndrome.
|
N/A | |
Completed |
NCT02787486 -
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study
|
||
Completed |
NCT03325647 -
TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY
|
Phase 4 | |
Enrolling by invitation |
NCT03836300 -
Parent and Infant Inter(X)Action Intervention (PIXI)
|
N/A | |
Recruiting |
NCT05498090 -
Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males With Klinefelter Syndrome
|
Phase 4 | |
Completed |
NCT00999310 -
Neuropsychologic, Neuroradiologic, Endocrinologic, and Genetic Aspects of Klinefelter Syndrome
|
N/A | |
Completed |
NCT02408445 -
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
|
Phase 4 | |
Completed |
NCT00896272 -
Adaptation Among Adolescents and Adults With Klinefelter Syndrome
|
||
Completed |
NCT02723305 -
Cardiometabolic Profiles of Boys With Klinefelter Syndrome
|
||
Completed |
NCT05581147 -
Thyroid Function and Structure IN Klinefelter Syndrome
|
||
Recruiting |
NCT05586802 -
Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
|
Phase 3 | |
Active, not recruiting |
NCT02430584 -
Whole Blood Specimen Collection From Pregnant Subjects
|
||
Completed |
NCT01817296 -
Klinefelter Fertility Preservation
|
N/A | |
Completed |
NCT01206270 -
Androgen for Leydig Cell Proliferation
|
Phase 2/Phase 3 | |
Withdrawn |
NCT00347464 -
Adaptive Behavior Assessment of Men With 49, XXXXY, Klinefelter Syndrome
|
N/A | |
Recruiting |
NCT05425953 -
Endocrine, Metabolic, Cardiovascular and Immunological Aspects of Sex Chromosome Abnormalities in Relation to Genotype
|