CompletedNot Applicable

Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome

United States48 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range8 Years – 18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline on the Delis-Kaplan Executive Function System

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: DSM Attention

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: Anxiety

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: Social Skills

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: Emotional Lability

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Trial details

NCT IDNCT01585831

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

Results submitted2021-07-16

View on ClinicalTrials.gov More Klinefelter Syndrome trials

Plain-language summary

Who can participate

Age range8 Years – 18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline on the Delis-Kaplan Executive Function System

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: DSM Attention

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: Anxiety

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: Social Skills

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)

Change From Baseline on the Conners Parent Rating Scales: Emotional Lability

Timeframe: Visit 1 (baseline) and Visit 5 (1 year)