Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty

Short name PUPIL

NCTNCT05341115Other idLeuprorelin-4002Other id2022-002471-11

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 79 participants (actual)
Sponsor: Takeda · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
China
Start: 12 Mar 2023
Primary completion: 19 Dec 2024
Completion: 10 Mar 2025
First posted: 22 Apr 2022
Last update posted: 4 Aug 2026
Conditions: Central Precocious Puberty

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2023202420252026

Ph 4
PUPIL
NCT05341115
12 Mar 2023 to 10 Mar 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study clinic 6 times to complete some assessments.

Interventions

Leuprorelin Acetate Depot 3MDrug

Arms1

Experimental
Leuprorelin Acetate Depot 3M 11.25 mg
Participants with CPP having body weight greater than equal to (≥)20 kilograms (kg) received the recommended dose of leuprorelin acetate depot 11.25 milligrams (mg) subcutaneous administration (SC) every 12 weeks based on the standard of 30～180 micrograms (μg)/kg/4 weeks for the 24-week Treatment Period. It was not recommended to exceed the dose above 180 μg/kg.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24
Time frame · Week 24
Registry description
The LH suppression was defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L).

Secondary outcomes(5)

Percentage of Participants With Tanner Stage Regression or No Progression at Week 24
Time frame · Baseline and Week 24
Registry description
Tanner Stage was used to measure pubertal development. Tanner Stage was based on progression through 5-stages. The progression was defined as either breast/genitals or pubic hair score had increased score compared with baseline score. Otherwise, the status was classified as regression or no progression. Baseline is defined as the assessment prior to the first dose of study drug.
Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
Time frame · Baseline, Weeks 24 and 36
Registry description
Plasma LH and FSH peak concentrations under GnRH stimulation were assessed.
Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24
Time frame · Baseline and Week 24
Registry description
Bone age was determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards.
Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24
Time frame · Baseline and Week 24
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Time frame · From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks)
Registry description
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as an AE with an onset that occurs after receiving study drug.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Week 24

Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24

Group	Value (percentage of participants)
Leuprorelin Acetate Depot 3M 11.25 mg	96.20

Secondary and other outcome results(5)

Secondary outcomeNumber· Baseline and Week 24

Percentage of Participants With Tanner Stage Regression or No Progression at Week 24

Group	Value (percentage of participants)
Leuprorelin Acetate Depot 3M 11.25 mg	96.20

Secondary outcomeMean· Baseline, Weeks 24 and 36

Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)

Group	Value (IU/L)	Spread
Leuprorelin Acetate Depot 3M 11.25 mg	1.224	1.410

Secondary outcomeNumber· Baseline and Week 24

Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24

Group	Value (percentage of participants)
Leuprorelin Acetate Depot 3M 11.25 mg	83.54

Secondary outcomeNumber· Baseline and Week 24

Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24

Group	Value (percentage of participants)
Leuprorelin Acetate Depot 3M 11.25 mg	60.76

Secondary outcomeCount of participants· From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks)

Number of Participants With Treatment-Emergent Adverse Events (TEAE)

Group	Value (Participants)
Leuprorelin Acetate Depot 3M 11.25 mg	27

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Leuprorelin Acetate Depot 3M 11.25 mgParticipants with CPP having body weight ≥20 kg received the recommended dose of leuprorelin acetate depot 11.25 mg SC every 12 weeks based on the standard of 30～180 μg/kg/4 weeks for the 24-week Treatment Period. It was not recommended to exceed the dose above 180 μg/kg.	0 / 79	1 / 79	4 / 79

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: up to 10 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Maximum age to participate is this study is up to 10 years (child). Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years 2. Body weight ≥20 kg 3. According to the National Consensus Statement in China (2015), CPP is diagnosed when secondary sexual characteristics appeared before the age of 8 years in girls and 9 years in boys, a peak LH level \>5.0 IU/L with LH/FSH \>0.6 in stimulating test; evidence of gonadal development by ultrasonography (multiple ovarian follicles ≥4 mm in any ovary or uterine enlargement in females or testicular volume ≥4 mL in males); advanced bone age (BA) ≥1 year; linear growth acceleration with higher growth velocity (GV) than normal children. BA is determined by Greulich and Pyle standards or TW3 standards at screening. Exclusion Criteria: 1. The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent. 2. The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease. 3. The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound. 4. The participant has a diagnosis of peripheral precocious puberty.

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