Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome
Information source: University of Colorado, Denver
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Klinefelter Syndrome; XXY Syndrome
Intervention: Testosterone gel 1% (Drug); Placebo gel (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Colorado, Denver Official(s) and/or principal investigator(s): Nicole Tartaglia, MD, Principal Investigator, Affiliation: University of Colorado School of Medicine
Overall contact: Susan Howell, MS, Phone: 720-777-8361, Email: susan.howell@childrenscolorado.org
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.
Clinical Details
Official title: Psychological and Motor Effects of Testosterone Therapy in Adolescents With XXY/Klinefelter Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Change from baseline on the Delis-Kaplan Executive Function SystemChange from baseline on the Bruininks-Oseretsky Test of Motor Development - 2 Change from baseline on the Conners Parent Rating Scales
Secondary outcome: Change from baseline on the Vineland Adaptive Behavior ScalesChange from baseline on the Wechsler Intelligence Scale for Children - Fourth Edition Change from baseline on the Comprehensive Test of Phonological Processing
Detailed description:
Klinefelter syndrome (47,XXY) is the most common chromosomal abnormality in humans and
occurs in approximately 1 in 650 males. Testosterone deficiency develops during adolescence
in the majority of individuals with XXY. However, there are no previous studies that
evaluate the psychological and motor effects of testosterone replacement therapy in
adolescents with XXY.
The study researchers are interested in learning if testosterone therapy initiated in early
puberty in XXY (KS) will lead to improvements in psychological and/or motor skills. They are
also interested in learning if genetic variations of the androgen receptor gene or the
parent-of-origin of the extra X chromosome influence the response to testosterone therapy.
Specific psychological factors to be studied include verbal and nonverbal cognitive skills,
attention, executive function (organization, problem-solving skills, inhibition), anxiety,
language, self-esteem, and other behavioral factors. Motor skills to be studied include
gross and fine motor skills, motor coordination, and motor planning.
Participants in the study will be randomized to one of two treatment groups, receiving
either testosterone gel or placebo, for 12 months. 60% of the study group will receive
testosterone, and 40% will receive placebo.
The research participants, parents/caregivers, and the members of the study team will be
blinded to the treatment group, and will not know whether they are receiving testosterone
gel or placebo treatments.
The supervising endocrinologist for the study will not be blinded and will know which
patients are in the testosterone and placebo groups. This will allow him to monitor results
to determine if participants in the placebo group may develop a significant need for
testosterone therapy during the study period. If this occurs, the patient will be switched
to the testosterone group and will continue to be monitored in the study.
All participants will be evaluated at the beginning of the study and at 1, 3, 6, and 12
months. Travel costs are included. Evaluations will include a combination of psychological
and motor skills testing, questionnaires completed by the parent/caregiver and study
participant, physical examinations, and blood draws for safety monitoring and genetic
studies.
Participation in the trial will last one year and includes 5 clinic visits to the
eXtraordinarY Kids Clinic at Children's Hospital Colorado in Denver.
Eligibility
Minimum age: 8 Years.
Maximum age: 18 Years.
Gender(s): Male.
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
Locations and Contacts
Susan Howell, MS, Phone: 720-777-8361, Email: susan.howell@childrenscolorado.org
Childrens Hospital Colorado, Aurora, Colorado 80045, United States; Recruiting Susan Howell, MS, Phone: 720-777-8361, Email: susan.howell@childrenscolorado.org Nicole Tartaglia, MD, Phone: 720-777-8087, Email: nicole.tartaglia@childrenscolorado.org Nicole R Tartaglia, MD, Principal Investigator
Additional Information
KS&A supports individuals with XXY/Klinefelter syndrome and other X&Y chromosome variations The eXtraordinary Kids Clinic at Children's Hospital Colorado is a multispecialty clinic that evaluates and treats children, adolescents, and young adults with all X&Y chromosome variations
Starting date: March 2012
Last updated: June 8, 2015
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