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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: Completed Phase 3 study, sponsored by Nemours Children's Clinic.
NCT01248416 is a Phase 3 study that has completed, run by Nemours Children's Clinic. The registered enrollment target is 76 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Differences in height gains
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 |
What the finished NCT01248416 record still lists
NCT01248416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Aromatase Inhibitor is the first listed.
NCT01248416 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01248416's enrollment target sits among peer trials
76 1773rd of 2000 higher than 228 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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