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A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
Plain-language guide to NCT07710430: phase 4 interventional trial of Leuprolide, 43 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07710430
- Phase
- phase 4
- Status
- recruiting participants
- Start
- 2026-08-01
- Completion (planned or actual)
- 2029-08-30
- Participants
- 43 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Central Precocious Puberty
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Leuprolide.
It had 1 arm (groups): Leuprorelin (experimental).
The registry classes the interventions as drug.
Who Took Part
43 planned participants were the target.
It was open to people of any sex aged up to 10 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Tanner stage =\>2. Girls younger than 9 years old, boys younger than 10 years old. Subjects who are diagnosed with central precocious puberty (CPP).
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: gnrh-independent precocious puberty, incomplete precocious puberty, progressive brain tumors, pituitary adenoma; hepatic impairment or abnormal liver function tests at screening; renal impairment or abnormal renal function at screening.
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 2026-08-01 with completion listed for 2029-08-30.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Peak luteinizing hormone (LH) level following gonadotropin-releasing hormone (GnRH) stimulation is < 4 International Units per Liter (IU/L) (time frame: 24 weeks after treatment initiation).
It also tracked 6 secondary outcomes, for example Changes from baseline in pubertal development: Tanner stage, Changes from baseline in growth related parameters: height in centimeter, Changes from baseline in growth related parameters: weight in kilograms and Safety: Number of participants with treatment-related adverse events as assessed by the investigator.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Leuprolide in 43 people.
It is still recruiting; 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.