Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
Public ClinicalTrials.gov record NCT05493709. 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
An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.
Study identification
- NCT ID
- NCT05493709
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 94 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 9 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
- Jun 2, 2023 (Actual)
- Primary completion
- Dec 7, 2025 (Actual)
- Completion
- May 24, 2026 (Actual)
- Last update posted
- Jul 20, 2026
2023 – 2026
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona University | Tucson | Arizona | 85719 | — |
| Rady Children's Hospital- San Diego | San Diego | California | 92123 | — |
| Nemours Children's Health Center | Jacksonville | Florida | 32207 | — |
| Johns Hopkins - All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Cook Children's | Fort Worth | Texas | 76104 | — |
| Virginia University | Charlottesville | Virginia | 22908 | — |
| Multicare Health System | 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 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05493709, 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 Jul 20, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05493709 live on ClinicalTrials.gov.