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NCT03325647 · ClinicalTrials.gov registry record · Phase 4
TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY
A Phase 4 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 4
- Development phase
- 72
- Enrollment target
NCT03325647: Completed Phase 4 study, sponsored by University of Colorado, Denver.
NCT03325647 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 72 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03325647, a Phase 4 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 72 participants
- Enrollment target
Study Summary
This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about the effect of testosterone on early health and development. The study is a total of three visits over 6 months with assessments of motor skills, body composition (muscle and fat), and hormone levels. This is a randomized, placebo-controlled study but all infants will receive testosterone treatment during the study period. The investigators will learn how testosterone treatment in infancy effects short term outcome measures on health and development.
Primary Outcome
Body fat percentage will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period
Interventions
- DRUG Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution
- DRUG Placebo injectable saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2021-05-05 |
| Phase | Phase 4 |
What the finished NCT03325647 record still lists
NCT03325647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution is the first listed.
NCT03325647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03325647 about?
NCT03325647 is a clinical study titled "TESTO: Testosterone Effects on Short-Term Outcomes in Infants With XXY". This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about the effect of testosterone on early health and development. The study is a total of three visits over 6 months with assessments of motor skills, body composition (muscle and fat), and hormone levels. This is...
What is the current status of trial NCT03325647?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 72 participants. The study started on 2017-11-06. Estimated completion is 2021-05-05.
What interventions are being tested in trial NCT03325647?
The interventions under investigation include: Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution (DRUG), Placebo injectable saline (DRUG).
Who is sponsoring clinical trial NCT03325647?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03325647's enrollment target sits among peer trials
72 1035th of 2000 higher than 961 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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