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Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment

NCT02408445 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-04-15

Study results available
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Summary

This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. The Investigators know that older boys and men with Klinefelter syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. The Investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.

Conditions

  • Klinefelter Syndrome

Interventions

DRUG

testosterone cypionate 200mg/ml

Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Shanlee M Davis, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
108 Days
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-08
Primary Completion
2018-01-31
Completion
2020-01-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408445 on ClinicalTrials.gov