Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
NCT ID: NCT02408445
Last Updated: 2020-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2015-05-08
2020-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Testosterone treatment
Testosterone cypionate (200 mg/ml) intramuscular injection
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.
No treatment
Subjects will not receive any testosterone during the study period.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Birth weight \<5%ile or \>95% for gestational age
* History of thrombosis in a first degree relative
* Exposure to androgen therapy outside of the study protocol.
42 Days
108 Days
MALE
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Shanlee M Davis, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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14-1720
Identifier Type: -
Identifier Source: org_study_id
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