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NCT00635817 · ClinicalTrials.gov registry record · Phase 3
A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
A Phase 3 study, sponsored by Abbott.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT00635817: Completed Phase 3 study, sponsored by Abbott.
NCT00635817 is a Phase 3 study that has completed, run by Abbott. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00635817, a Phase 3 study, has completed, sponsored by Abbott.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).
Primary Outcome
Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone \>= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.
Interventions
- DRUG Leuprolide acetate 11.25 mg
- DRUG Leuprolide acetate 30 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 3 |
What the finished NCT00635817 record still lists
NCT00635817 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Leuprolide acetate 11.25 mg is the first listed.
NCT00635817 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00635817 about?
NCT00635817 is a clinical study titled "A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty". The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).
What is the current status of trial NCT00635817?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2008-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00635817?
The interventions under investigation include: Leuprolide acetate 11.25 mg (DRUG), Leuprolide acetate 30 mg (DRUG).
Who is sponsoring clinical trial NCT00635817?
This trial is sponsored by Abbott, which has 181 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00635817's enrollment target sits among peer trials
84 1749th of 2000 higher than 250 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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