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

University of Colorado Denver (CU Denver)

Status and phase: Completed; Phase 4

Conditions: Klinefelter Syndrome

Treatments: Drug: testosterone cypionate 200mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT02408445

14-1720

UL1TR001082 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Male

Ages: 42 to 108 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male infants with 47,XXY karyotype

Exclusion criteria

• Gestational age at birth <36 weeks
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Testosterone treatment

Experimental group

Description:

Testosterone cypionate (200 mg/ml) intramuscular injection

Treatment:

Drug: testosterone cypionate 200mg/ml

No treatment

No Intervention group

Description:

Subjects will not receive any testosterone during the study period.