Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Synd… (NCT01585831) | Clinical Trial Compass
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 range
8 Years – 18 Years
Sex
MALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline on the Delis-Kaplan Executive Function System
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)
2
Change From Baseline on the Bruininks-Oseretsky Test of Motor Development - 2
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)
3
Change From Baseline on the Conners Parent Rating Scales: DSM Attention
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)
4
Change From Baseline on the Conners Parent Rating Scales: DSM Hyperactivity
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)
5
Change From Baseline on the Conners Parent Rating Scales: Anxiety
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)
6
Change From Baseline on the Conners Parent Rating Scales: Social Skills
Timeframe: Visit 1 (baseline) and Visit 5 (1 year)
7
Change From Baseline on the Conners Parent Rating Scales: Emotional Lability