Trials / Completed
CompletedNCT03695237
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 2 Years – 11 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Leuprolide Acetate (LA) | Administered intramuscularly as an injection |
Timeline
- Start date
- 2018-10-24
- Primary completion
- 2021-05-06
- Completion
- 2023-11-29
- First posted
- 2018-10-04
- Last updated
- 2024-05-29
- Results posted
- 2023-05-16
Locations
18 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03695237. Inclusion in this directory is not an endorsement.