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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 is a Phase 4 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 72 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03325647
The ClinicalTrials.gov registry entry for NCT03325647 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution is the first listed.
NCT03325647 reports 0 study locations.
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.
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