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Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
Plain-language guide to NCT05493709: phase 3 interventional trial of Leuprolide, 94 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05493709
- Phase
- phase 3
- Status
- completed
- Start
- 2023-06-02
- Completion (planned or actual)
- 2025-12-07
- Participants
- 94 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Puberty; Precocious, Central
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Leuprolide.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
More on the Plan
This is a multi-center, open-label, single-arm study.
Who Took Part
Enrollment: 94 actual participants took part.
It was open to people of any sex aged from 2 years up to 9 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive). Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRHa treatment for CPP. Pubertal-type LH response at 60 minutes post GnRHa stimulation test before treatment initiation \> 5 mIU/mL. Willing and able to participate in the study. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year.
The full record lists 9 inclusion and 15 exclusion criteria; among the exclusions: prior or current gnrh treatment for cpp; non-progressing isolated premature thelarche; presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. patients with hamartomas or adenomas not requiring surgery are eligible.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Leuprolide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-06-02 with completion listed for 2025-12-07.
It ran at 41 sites in China (24), United States (10), Taiwan (6) and Puerto Rico (1).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 5 secondary outcomes, for example Acute-On-Chronic (AOC) phenomenon of serum testosterone and LH.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Leuprolide in 94 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Leuprolide compound page, all human trials.
Our Notes on the Compound
Leuprolide: A 9-amino-acid GnRH analog (Lupron, Eligard) that lowers sex-hormone levels with ongoing use; used in prostate cancer, endometriosis and early puberty.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.