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NCT01248416 · ClinicalTrials.gov registry record · Phase 3
Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature
A Phase 3 study, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 76
- Enrollment target
NCT01248416 is a Phase 3 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 76 participants.
The verdict
NCT01248416, a Phase 3 study, has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 76 participants
- Enrollment target
Study Summary
When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. Human and animal data show that estrogen, in females and males, is a principal regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs), which block testosterone to estrogen conversion, in boys with different growth disorders, we have shown that AIs may have beneficial effects enhancing height potential in growth-retarded males, without affecting their puberty. However, no direct comparison of the effect of AIs alone vs. conventional GH treatment has been done to date. This study will assess the effect of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent boys with idiopathic short stature.
Interventions
- DRUG Aromatase Inhibitor
- DRUG Growth Hormone
- DRUG Aromatase Inhibitor and Growth Hormone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2010-11 |
| Est. Completion | 2016-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01248416
The ClinicalTrials.gov registry entry for NCT01248416 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Aromatase Inhibitor is the first listed.
NCT01248416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01248416 about?
NCT01248416 is a clinical study titled "Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature". When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. Human and animal...
What is the current status of trial NCT01248416?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 76 participants. The study started on 2010-11. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01248416?
The interventions under investigation include: Aromatase Inhibitor (DRUG), Growth Hormone (DRUG), Aromatase Inhibitor and Growth Hormone (DRUG).
Who is sponsoring clinical trial NCT01248416?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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