Trial reportThe Journal of clinical endocrinology and metabolism2020
Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty.
Trial report in The Journal of clinical endocrinology and metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 32 citations in OpenAlex.
- Utility of a 40-minute LH level after depot leuprolide for diagnosis and treatment monitoring in girls with CPP.Journal of endocrinological investigation · 2026Trial
- Unstimulated Luteinizing Hormone for Assessment of Suppression during Treatment of Central Precocious Puberty with 6-Month Subcutaneous Leuprolide Acetate: Correlations with Clinical Response.Hormone research in paediatrics · 2025Trial
- Effect of dietary with Zhibai dihuang pills and gonadotropin-releasing-hormone-analogue on girls with precocious and rapidly progressive puberty.World journal of clinical cases · 2024Trial
- Effects of leuprorelin acetate microspheres on sex hormones, secondary sexual characteristics, and predicted adult height in early and fast puberty girls: a real-world, single-arm, retrospective cohort study.Translational pediatrics · 2026Article
- A survey on treatment satisfaction with leuprorelin acetate in girls with central precocious puberty.Clinical pediatric endocrinology : case reports and clinical investigations : official journal of the Japanese Society for Pediatric Endocrinology · 2026Article
- Effectiveness and Safety of Hormonal Treatments in Children with Growth Disorders: A Systematic Review of Clinical Evidence.Clinics and practice · 2026Review
- Long-term Safety, Efficacy, and PROs: Phase 3 Study of Leuprolide Acetate 6-month IM Depot in Central Precocious Puberty.Journal of the Endocrine Society · 2026Article
- Long-Acting Gonadotropin-Releasing Hormone Analogues for Central Precocious Puberty, Including 45-Mg 6-Month Subcutaneous Leuprolide Acetate: Use for Treatment and Treatment Monitoring.Hormone research in paediatrics · 2025Review
- Precocious Puberty and GnRH Analogs: Current Treatment Practices and Perspectives among US Pediatric Endocrinologists.Hormone research in paediatrics · 2025Article
- Impact of dietary patterns on body weight in girls with central precocious puberty treated with leuprolide during the COVID-19 pandemic.Frontiers in pediatrics · 2025Article
- Puberty Blocker and Aging Impact on Testicular Cell States and Function.bioRxiv : the preprint server for biology · 2024Article
- Critical appraisal of diagnostic laboratory tests in the evaluation of central precocious puberty.Frontiers in pediatrics · 2024Article
- Efficacy and Safety of Leuprolide Acetate 6-Month Depot for the Treatment of Central Precocious Puberty: A Phase 3 Study.Journal of the Endocrine Society · 2023Article
- Analysis of the efficacy of Dabuyin pill combined with gonadotropin-releasing hormone analogue in the treatment of central precocious puberty girls based on network pharmacology.Translational pediatrics · 2023Article
- Determination of Leuprolide-Fatty Acid Conjugate in Rat Plasma Using LC-MS/MS and Its Pharmacokinetics after Subcutaneous Administration in Rats.Molecules (Basel, Switzerland) · 2022Article
- Diagnostic Value of LH Peak Value of the GnRH Stimulation Test for Girls with Precocious Puberty and Its Correlation with Body Mass Index.Computational and mathematical methods in medicine · 2022Article
- Gonadotropin-releasing hormone analog therapies for children with central precocious puberty in the United States.Frontiers in pediatrics · 2022Review
- Diagnosis and management of precocious sexual maturation: an updated review.European journal of pediatrics · 2021Review
- Delayed and Precocious Puberty: Genetic Underpinnings and Treatments.Endocrinology and metabolism clinics of North America · 2020Review
Corrections and comments
- Erratum issued
Authors and funding
9 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
contextGonadotropin-releasing hormone agonists (GnRHas) are standard of care for central precocious puberty (CPP). A 6-month subcutaneous injection has recently been approved by the Food and Drug Administration.
objectiveDetermine efficacy, pharmacokinetics, and safety of 6-month 45-mg subcutaneous leuprolide acetate for CPP.
designPhase 3 multicenter, open-label, single-arm study.
setting25 sites in 6 countries. SUBJECTS: 64 GnRHa-naïve children with CPP (age: 7.5 ± 0.1 years) received study drug: 59 completed the study. INTERVENTION(S): 2 doses of 45-mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks; children were followed for 48 weeks. MAIN OUTCOME MEASURE(S): Percentage of children with serum luteinizing hormone (LH) <4 IU/L 30 minutes following GnRHa stimulation at week 24.
results54/62 (87%) children achieved poststimulation LH <4 IU/L at week 24; 49/56 (88%) girls and 1/2 boys maintained peak LH <4 IU/L at week 48. Mean growth velocity decreased from 8.9 cm/year at week 4 to 6.0 cm/year at week 48. Mean bone age was advanced 3.0 years beyond chronological age at screening and 2.7 years at week 48. Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys. Adverse events were mild and did not cause treatment discontinuation.
conclusionsA small volume of 45-mg subcutaneous leuprolide acetate administered at a 6-month interval effectively suppressed pubertal hormones and stopped or caused regression of pubertal progression. This long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy for children with CPP.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.