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NCT03695237 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 45
- Enrollment target
NCT03695237: Completed Phase 3 study, sponsored by AbbVie.
NCT03695237 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 45 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03695237, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 45 participants
- Enrollment target
Study Summary
The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.
Primary Outcome
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Interventions
- DRUG Leuprolide Acetate (LA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2023-11-29 |
| Phase | Phase 3 |
What the finished NCT03695237 record still lists
NCT03695237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Leuprolide Acetate (LA) is the first listed.
NCT03695237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03695237 about?
NCT03695237 is a clinical study titled "A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)". The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a...
What is the current status of trial NCT03695237?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2018-10-24. Estimated completion is 2023-11-29.
What interventions are being tested in trial NCT03695237?
The interventions under investigation include: Leuprolide Acetate (LA) (DRUG).
Who is sponsoring clinical trial NCT03695237?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03695237's enrollment target sits among peer trials
45 1870th of 2000 higher than 127 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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