A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Public ClinicalTrials.gov record NCT03695237. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03695237
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 45 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 24, 2018 (Actual)
- Primary completion
- May 6, 2021 (Actual)
- Completion
- Nov 29, 2023 (Actual)
- Last update posted
- May 29, 2024
2018 – 2023
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pediatric Endocrinology Associates /ID# 200629 | Long Beach | California | 90806-1651 | — |
| Rady Children's Hospital San Diego /ID# 202491 | San Diego | California | 92123 | — |
| Children's Hospital Colorado /ID# 201645 | Aurora | Colorado | 80045 | — |
| Pediatric Endocrine Associates /ID# 201089 | Greenwood Village | Colorado | 80111 | — |
| Nemours Children's Health System /ID# 201331 | Jacksonville | Florida | 32207 | — |
| Arnold Palmer Hospital /ID# 201624 | Orlando | Florida | 32806 | — |
| Van Meter Pediatric Endocrinology /ID# 201688 | Atlanta | Georgia | 30318-2508 | — |
| Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878 | Idaho Falls | Idaho | 83404-7596 | — |
| Indiana University /ID# 200526 | Indianapolis | Indiana | 46202 | — |
| Pediatric Endocrine Associates /ID# 202396 | Boston | Massachusetts | 02114 | — |
| University of Minnesota /ID# 200508 | Minneapolis | Minnesota | 55455-1450 | — |
| Children's Mercy Hospital/ID# 200221 | Kansas City | Missouri | 64111 | — |
| University of Oklahoma /ID# 200659 | Tulsa | Oklahoma | 74135-2527 | — |
| Penn State Hershey Medical Ctr /ID# 200287 | Hershey | Pennsylvania | 17033-2360 | — |
| Children's Hospital of Philadelphia - Main /ID# 203846 | Philadelphia | Pennsylvania | 19104-4319 | — |
| Cook Children's Med. Center /ID# 212937 | Fort Worth | Texas | 76104 | — |
| Multicare Institute for Research and Innovation /ID# 202188 | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03695237, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 29, 2024 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03695237 live on ClinicalTrials.gov.