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NCT Number: NCT05341115

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

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.

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Key information

Conditions

Central Precocious Puberty Endocrine System Diseases Gonadal Disorders Puberty, Precocious

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Children's Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

The drug being tested in this study is called leuprorelin acetate depot 3M. Leuprorelin acetate depot 3M will be tested to treat children who have central precocious puberty. This study will look at the efficacy and safety of leuprorelin acetate depot 3M in the treatment of CPP.

The study will enroll approximately 80 participants with CPP. Participants with a bodyweight of ≥ 20 kg will receive the recommended dose of leuprorelin acetate depot 3M in a 24 weeks Treatment Period followed by a 12 weeks Post-treatment follow-up period. Participants will be assigned to the following drug administration:

  • Leuprorelin Acetate Depot 3M 11.25 mg

Participants will receive leuprorelin acetate depot 3M 11.25 mg as subcutaneous (SC) injection on Weeks 0, 12, and 24. The gonadotropin-releasing hormone agonist (GnRHa) stimulation, basal luteinizing hormone (LH), and follicle-stimulating hormone (FSH) levels will be tested pre-dose of every SC injection of the study drug or at premature termination.

This multi-center trial will be conducted in China. The overall time to participate in this study is 38 weeks. Participants will make a follow-up visit to the site at approximately 12 weeks after the last dose of study treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Leuprorelin Acetate Depot 3M

Drug

Leuprorelin Acetate Depot 3M SC injections.

Other names: Leuprolide acetate Depot 3M

Primary outcomes

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

    Time frame: Week 24

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

Secondary outcomes

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

    Time frame: Baseline and Week 24

    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.

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

    Time frame: Baseline, Weeks 24 and 36

    Plasma LH and FSH peak concentrations under GnRH stimulation were assessed.

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

    Time frame: Baseline and Week 24

    Bone age was determined by Greulich and Pyle standards or Tanner-Whitehouse 3 (TW3) standards.

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

    Time frame: Baseline and Week 24

  5. 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)

    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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

An Open Label, Multicenter, Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty (CPP)

Acronym: PUPIL

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 22, 2022
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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