Trial record 1 of 18 for:    "Klinefelter syndrome"
Previous Study | Return to List | Next Study

Study of Psychological and Motor Effects of Testosterone in Adolescents With XXY/Klinefelter Syndrome (TestoXXY/KS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by University of Colorado, Denver
Sponsor:
Collaborators:
Colorado Clinical & Translational Sciences Institute
Children's Hospital Colorado
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01585831
First received: March 30, 2012
Last updated: January 4, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention
Klinefelter Syndrome
XXY Syndrome
Drug: Testosterone gel 1%
Drug: Placebo gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Psychological and Motor Effects of Testosterone Therapy in Adolescents With XXY/Klinefelter Syndrome

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change from baseline on the Delis-Kaplan Executive Function System [ Time Frame: Visit 1 (baseline) and Visit 5 (1 year) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    This questionnaire allows parents to rate many aspects of behavior including attention, hyperactivity, anxiety, social skills, and emotional lability.


Secondary Outcome Measures:
  • Change from baseline on the Vineland Adaptive Behavior Scales [ Time Frame: Visit 1 (baseline) and Visit 5 (1 year) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    This standardized test evaluates reading and language skills.


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Testosterone gel Drug: Testosterone gel 1%
Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
Placebo Comparator: Placebo gel Drug: Placebo gel
The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.

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

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01585831

Contacts
Contact: Susan Howell, MS 720-777-8361 susan.howell@childrenscolorado.org

Locations
United States, Colorado
Childrens Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Susan Howell, MS    720-777-8361    susan.howell@childrenscolorado.org   
Contact: Nicole Tartaglia, MD    720-777-8087    nicole.tartaglia@childrenscolorado.org   
Principal Investigator: Nicole R Tartaglia, MD         
Sponsors and Collaborators
University of Colorado, Denver
Colorado Clinical & Translational Sciences Institute
Children's Hospital Colorado
  More Information

Additional Information:
No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01585831     History of Changes
Other Study ID Numbers: 11-0874, 1K23NS070337
Study First Received: March 30, 2012
Last Updated: January 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Klinefelter syndrome
XXY syndrome
Sex Chromosome Abnormality
Testosterone replacement therapy

Additional relevant MeSH terms:
Klinefelter Syndrome
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 28, 2014