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NCT02408445 · ClinicalTrials.gov registry record · Phase 4
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
A Phase 4 study of Klinefelter Syndrome, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02408445: Completed Phase 4 study of Klinefelter Syndrome, sponsored by University of Colorado, Denver.
NCT02408445 is a Phase 4 study of Klinefelter Syndrome that has completed, run by University of Colorado, Denver. The registered enrollment target is 20 participants, below the 284-participant average among 4 other Klinefelter Syndrome trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02408445, a Phase 4 study of Klinefelter Syndrome, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG testosterone cypionate 200mg/ml
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2015-05-08 |
| Est. Completion | 2020-01-01 |
| Phase | Phase 4 |
What the finished NCT02408445 record still lists
NCT02408445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 284-participant average among 4 other Klinefelter Syndrome trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Klinefelter Syndrome appearing as the primary indexed condition, and to 1 intervention - of which testosterone cypionate 200mg/ml is the first listed.
NCT02408445 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02408445 about?
NCT02408445 is a clinical study titled "Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment". 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 ...
What is the current status of trial NCT02408445?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2015-05-08. Estimated completion is 2020-01-01.
What conditions does trial NCT02408445 study?
This clinical trial studies the following conditions: Klinefelter Syndrome.
What interventions are being tested in trial NCT02408445?
The interventions under investigation include: testosterone cypionate 200mg/ml (DRUG).
Who is sponsoring clinical trial NCT02408445?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02408445 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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