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Authors
Lim, Chay Ngee https://orcid.org/0000-0002-7307-9851
Al Yacoub, Omar N. https://orcid.org/0000-0002-2069-8472
Mostafa, Nael M. https://orcid.org/0000-0003-3065-768X
Salem, Ahmed Hamed https://orcid.org/0000-0002-9261-1583
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Clinical Trials BETA
Clinical trials referenced in this document:
nct00635817 at ClinicalTrials.govDocuments that mention this clinical trial
Fixed Dosing of Leuprolide Acetate, a GnRH Agonist, in Children with Central Precocious Puberty: A Population Pharmacokinetic Justification
https://doi.org/10.1007/s40272-025-00733-2
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Funding
Funding for this research was provided by:
AbbVie
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Article History
Received: 7 July 2025
Accepted: 14 December 2025
First Online: 13 March 2026
Declarations
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: Omar N. Al Yacoub, Ahmed H. Salem, and Nael M. Mostafa are employees of AbbVie and may hold AbbVie stock or options. Chay Ngee Lim is a former employee of AbbVie and may hold stock in the company.
: The study reported herein was conducted in accordance with the International Council for Harmonisation guidelines, applicable regulations, and guidelines governing clinical study conduct and the ethical principles that have their origin in the Declaration of Helsinki. Approval was granted by institutional review boards and independent ethics committees at participating institutions.
: Informed consent was obtained from all individual participants included in the study.
: Patients signed an informed consent form regarding publishing their data.
: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols, clinical study reports, or analysis plans), provided the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following the review and approval of a research proposal and a statistical analysis plan, and the execution of a data sharing agreement. Data requests can be submitted at any time after approval in the USA and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: then select “Home”.
: Not applicable.
: All authors contributed to the study conception and design. Data collection and analysis were performed by CL, OA, AS, and NM. The first draft of the manuscript was written by CL and OA and all authors critically reviewedprevious versions of the manuscript. All authors read and approved the final manuscript.
