Trial Outcomes & Findings for A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty (NCT NCT05341115)
NCT ID: NCT05341115
Last Updated: 2026-08-04
Results Overview
The LH suppression was defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L).
COMPLETED
PHASE4
79 participants
Week 24
2026-08-04
Participant Flow
A total of 79 participants took part in the study at 5 investigative sites in China from 12 March 2023 to 10 March 2025.
Participants with a diagnosis of central precocious puberty (CPP) received leuprorelin acetate depot 11.25 milligrams (mg).
Participant milestones
| Measure |
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 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.
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|---|---|
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Overall Study
STARTED
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79
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Overall Study
COMPLETED
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77
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Overall Study
NOT COMPLETED
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2
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Reasons for withdrawal
| Measure |
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 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.
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Overall Study
Adverse Event
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1
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Baseline characteristics by cohort
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 Participants
Participants 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.
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Age, Continuous
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7.59 years
STANDARD_DEVIATION 1.019 • n=20 Participants
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Sex: Female, Male
Female
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78 Participants
n=20 Participants
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Sex: Female, Male
Male
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1 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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79 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Asian
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79 Participants
n=20 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=20 Participants
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Race (NIH/OMB)
White
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0 Participants
n=20 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: Week 24Population: The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug.
The LH suppression was defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L).
Outcome measures
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 Participants
Participants 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.
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|---|---|
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Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24
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96.20 percentage of participants
Interval 89.3 to 99.21
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SECONDARY outcome
Timeframe: Baseline and Week 24Population: The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug.
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.
Outcome measures
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 Participants
Participants 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.
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Percentage of Participants With Tanner Stage Regression or No Progression at Week 24
Tanner Stage Regression or No Progression
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96.20 percentage of participants
Interval 89.3 to 99.21
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Percentage of Participants With Tanner Stage Regression or No Progression at Week 24
Tanner Stage Regression
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32.91 percentage of participants
Interval 22.75 to 44.4
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Percentage of Participants With Tanner Stage Regression or No Progression at Week 24
No Tanner Stage Progression
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63.29 percentage of participants
Interval 51.69 to 73.86
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SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 36Population: The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug. Number analyzed is the number of participants with data available for analysis at the specified timepoints.
Plasma LH and FSH peak concentrations under GnRH stimulation were assessed.
Outcome measures
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 Participants
Participants 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.
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Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
LH: Baseline
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1.224 IU/L
Standard Deviation 1.410
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Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
LH: Week 24
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0.457 IU/L
Standard Deviation 0.298
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Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
LH: Week 36
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0.458 IU/L
Standard Deviation 0.293
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Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
FSH: Baseline
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3.213 IU/L
Standard Deviation 1.593
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Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
FSH: Week 24
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1.457 IU/L
Standard Deviation 0.691
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Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH)
FSH: Week 36
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1.576 IU/L
Standard Deviation 0.708
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SECONDARY outcome
Timeframe: Baseline and Week 24Population: The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug.
Bone age was determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards.
Outcome measures
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 Participants
Participants 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.
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Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24
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83.54 percentage of participants
Interval 73.51 to 90.94
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SECONDARY outcome
Timeframe: Baseline and Week 24Population: The enrolled population set included all the eligible participants enrolled in this study, i.e., all participants enrolled in this study who met the inclusion criteria and did not meet any of the exclusion criteria, regardless of whether they received the study drug.
Outcome measures
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 Participants
Participants 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.
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Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24
Decrease in FMV Gn Urinary LH Values
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60.76 percentage of participants
Interval 49.13 to 71.56
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Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24
Decrease in FMV Gn Urinary FSH Values
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62.03 percentage of participants
Interval 50.41 to 72.72
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SECONDARY outcome
Timeframe: From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks)Population: The safety population set included all included participants who had been under treatment with leuprorelin or who were first prescribed leuprorelin, received at least one dose and completed one follow-up visit.
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.
Outcome measures
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 Participants
Participants 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.
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Number of Participants With Treatment-Emergent Adverse Events (TEAE)
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27 Participants
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Adverse Events
Leuprorelin Acetate Depot 3M 11.25 mg
Serious adverse events
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 participants at risk
Participants 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.
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Infections and infestations
Acute Appendicitis
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1.3%
1/79 • Number of events 1 • From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks)
The safety population set included all included participants who had been under treatment with leuprorelin or who were first prescribed leuprorelin, received at least one dose and completed one follow-up visit.
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Other adverse events
| Measure |
Leuprorelin Acetate Depot 3M 11.25 mg
n=79 participants at risk
Participants 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.
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|---|---|
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Infections and infestations
Upper respiratory tract infection
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5.1%
4/79 • Number of events 4 • From first dose of study drug up to 12 weeks post last dose or early termination Visit (ET) (up to approximately 36 weeks)
The safety population set included all included participants who had been under treatment with leuprorelin or who were first prescribed leuprorelin, received at least one dose and completed one follow-up visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place