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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Psychological and Motor Effects of Testosterone Therapy in Adolescents With XXY/Klinefelter Syndrome

Brief 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.

Detailed Summary:

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
Sponsor: University of Colorado, Denver

Current Primary Outcome:

• Change from baseline on the Delis-Kaplan Executive Function System [ Time Frame: Visit 1 (baseline) and Visit 5 (1 year) ]
  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.
• Change from baseline on the Bruininks-Oseretsky Test of Motor Development - 2 [ Time Frame: Visit 1 (baseline) and Visit 5 (1 year) ]
  This test evaluates many aspects of motor functioning including fine and gross motor skills, visual motor integration, motor planning, and motor coordination
• Change from baseline on the Conners Parent Rating Scales [ Time Frame: Visit 1 (baseline), Visit 4 (6 months) and Visit 5 (1 year) ]
  This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change from baseline on the Vineland Adaptive Behavior Scales [ Time Frame: Visit 1 (baseline) and Visit 5 (1 year) ]
  The Vineland is an interview evaluating adaptive skills in the areas of communication, daily living skills, social skills, and motor skills.
• Change from baseline on the Wechsler Intelligence Scale for Children - Fourth Edition [ Time Frame: Visit 1 (baseline) and Visit 5 (1 year) ]
  This standardized assessment of cognitive functioning allows for evaluation of verbal and nonverbal cognitive skills, working memory, and processing speed.
• Change from baseline on the Comprehensive Test of Phonological Processing [ Time Frame: Visit 1 (baseline) and Visit 5 (1 year) ]
  This standardized test evaluates reading and language skills.

Original Secondary Outcome: Same as current

Information By: University of Colorado, Denver

Dates:
Date Received: March 30, 2012
Date Started: March 2012
Date Completion: June 2017
Last Updated: February 16, 2017
Last Verified: February 2017