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

NCT05341115 | Completed Phase 4 Results

• 2 other identifiers: Leuprorelin-40022022-002471-11
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Central Precocious Puberty

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

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

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

  Week 24

Secondary Outcomes (5)

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

  Baseline and Week 24

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

  Baseline, Weeks 24 and 36

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

  Baseline and Week 24

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

  Baseline and Week 24

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

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

Study Arms (1)

Leuprorelin Acetate Depot 3M 11.25 mg

EXPERIMENTAL

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.

Drug: Leuprorelin Acetate Depot 3M

Interventions

Leuprorelin Acetate Depot 3M DRUG

Leuprorelin Acetate Depot 3M SC injections.

Also known as: Leuprolide acetate Depot 3M

Leuprorelin Acetate Depot 3M 11.25 mg

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Maximum age to participate is this study is up to 10 years (child). Early appearance of secondary sexual characteristics: Girls ≤8 years, Boys ≤9years
• Body weight ≥20 kg
• 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.

You may not qualify if:

• The participant has received GnRHa treatment in a previous clinical study or as a therapeutic agent.
• The participant has a history or clinical manifestations of significant adrenal or thyroid diseases or intracranial tumor OR has a history of malignant disease.
• The participant has a history of hypersensitivity or allergies to leuprorelin, or related compounds including any excipients of the compound.
• The participant has a diagnosis of peripheral precocious puberty.

Sponsors & Collaborators

• Takeda: lead

Study Sites (5)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100033, China

Location

the First A liated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510062, China

Location

The Hospital attached by the Torigji Medical College, Huazhong Science and Technology University.

Wuhan, Hubei, 430030, China

Location

Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250021, China

Location

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, 200062, China

Location

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: March 14, 2023
• Primary Completion: December 19, 2024
• Study Completion: March 10, 2025
• Last Updated: January 13, 2026
• Results First Posted: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (5)