Trial Outcomes & Findings for A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty (NCT NCT05341115)

Results Overview

The LH suppression was defined as LH peak value in GnRH stimulation ≤3.0 international unit per liter (IU/L).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

Week 24

Results posted on

2026-01-13

Participant Flow

A total of 79 participants took part in the study at 5 investigative sites in China from 14 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

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.
Overall Study STARTED	79
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	2

Reasons for withdrawal

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.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

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.
Age, Continuous	7.59 years STANDARD_DEVIATION 1.019 • n=210 Participants
Sex: Female, Male Female	78 Participants n=210 Participants
Sex: Female, Male Male	1 Participants n=210 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=210 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=210 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=210 Participants
Race (NIH/OMB) Asian	79 Participants n=210 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=210 Participants
Race (NIH/OMB) Black or African American	0 Participants n=210 Participants
Race (NIH/OMB) White	0 Participants n=210 Participants
Race (NIH/OMB) More than one race	0 Participants n=210 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=210 Participants

PRIMARY outcome

Timeframe: Week 24

Population: 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

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.
Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24	97.47 percentage of participants Interval 91.15 to 99.69

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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

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.
Percentage of Participants With Tanner Stage Regression or No Progression at Week 24 Tanner Stage Regression or No Progression	97.47 percentage of participants Interval 91.15 to 99.69
Percentage of Participants With Tanner Stage Regression or No Progression at Week 24 Tanner Stage Regression	32.91 percentage of participants Interval 22.75 to 44.4
Percentage of Participants With Tanner Stage Regression or No Progression at Week 24 No Tanner Stage Progression	64.56 percentage of participants Interval 52.99 to 75.0

SECONDARY outcome

Timeframe: Baseline, Weeks 24 and 36

Population: 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

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.
Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) LH: Baseline	1.224 IU/L Standard Deviation 1.410
Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) LH: Week 24	0.454 IU/L Standard Deviation 0.297
Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) LH: Week 36	0.458 IU/L Standard Deviation 0.293
Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) FSH: Baseline	3.213 IU/L Standard Deviation 1.593
Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) FSH: Week 24	1.457 IU/L Standard Deviation 0.686
Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) FSH: Week 36	1.569 IU/L Standard Deviation 0.706

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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

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.
Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24	84.81 percentage of participants Interval 74.97 to 91.9

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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.

Outcome measures

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.
Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24 Decrease in FMV Gn Urinary LH Values	62.03 percentage of participants Interval 50.41 to 72.72
Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24 Decrease in FMV Gn Urinary FSH Values	63.29 percentage of participants Interval 51.69 to 73.86

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

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.
Number of Participants With Treatment-Emergent Adverse Events (TEAE)	27 Participants

Adverse Events

Leuprorelin Acetate Depot 3M 11.25 mg

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

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.
Infections and infestations Acute Appendicitis	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.

Other adverse events

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.
Infections and infestations Upper respiratory tract infection	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.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place