NCT02408445

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 8, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

April 15, 2020

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

2.7 years

First QC Date

March 31, 2015

Results QC Date

February 21, 2019

Last Update Submit

April 2, 2020

Conditions

Klinefelter Syndrome

Keywords

body compositionKlinefelter syndromeXXYsex chromosome variationsex chromsome aneuploidy

Outcome Measures

Primary Outcomes (1)

  • Change in Body Fat Percent Z-score

    Body fat percentage will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period. Age and sex-normed z-scores will be calculated. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Change in the z-score over time, if following a normal growth curve, is 0. Positive change in z-scores indicates a gain in body fat above growth typically expected. Negative change in z-scores indicates a gain in body fat that is less than typically expected.

    Baseline and 3 months

Secondary Outcomes (11)

  • Serum Luteinizing Hormone (LH)

    baseline only

  • Serum Follicle Stimulating Hormone (FSH)

    baseline only

  • Serum Total Testosterone

    baseline only

  • Serum Inhibin B (INHB)

    baseline only

  • Serum Anti-Mullerian Hormone (AMH)

    baseline only

  • +6 more secondary outcomes

Study Arms (2)

Testosterone treatment

EXPERIMENTAL

Testosterone cypionate (200 mg/ml) intramuscular injection

Drug: testosterone cypionate 200mg/ml

No treatment

NO INTERVENTION

Subjects will not receive any testosterone during the study period.

Interventions

testosterone cypionate 200mg/mlDRUG

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.

Testosterone treatment

Eligibility Criteria

Age42 Days - 108 Days
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male infants with 47,XXY karyotype

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Klinefelter Syndrome

Interventions

testosterone 17 beta-cypionate

Condition Hierarchy (Ancestors)

Sex Chromosome Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSex Chromosome DisordersChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesHypogonadism

Results Point of Contact

Title
Dr. Shanlee Davis
Organization
University of Colorado
shanlee.davis@childrenscolorado.org
720-777-6073

Study Officials

  • Shanlee M Davis, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

May 8, 2015

Primary Completion

January 31, 2018

Study Completion

January 1, 2020

Last Updated

April 15, 2020

Results First Posted

April 15, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)