Phase 4
N=79
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Central Precocious Puberty
Bottom Line
View on ClinicalTrials.gov: NCT05341115 ↗Enrolled (actual)
79
Serious AEs
1.3%
Results posted
Jan 2026
Primary outcome: Primary: Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24 — 97.47 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Leuprorelin Acetate Depot 3M (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Peak Luteinizing Hormone (LH) Suppression in Gonadotropin-Releasing Hormone (GnRH) Stimulation at Week 24 |
97.47 | — |
| SECONDARY Percentage of Participants With Tanner Stage Regression or No Progression at Week 24 |
97.47; 32.91; 64.56 | — |
| SECONDARY Concentrations of Basal Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) |
1.224; 0.454; 0.458; 3.213; 1.457; 1.569 | — |
| SECONDARY Percentage of Participants With Decreased Ratio of Bone Age Over Chronological Age at Week 24 |
84.81 | — |
| SECONDARY Percentage of Participants With Decreased First Morning Voided (FMV) Urinary Gonadotropin (Gn) at Week 24 |
62.03; 63.29 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAE) |
27 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05341115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.