Pharmacokinetic and exposure-response analyses of leuprolide following administration of leuprolide acetate 3-month depot formulations to children with central precocious puberty.

Background And Objective: A pharmacokinetic substudy was conducted within a phase 3 clinical trial that evaluated the efficacy and safety of two leuprolide acetate 3-month depot formulations in children with central precocious puberty (CPP), where the pharmacokinetics of leuprolide and the exposure-response relationship between leuprolide concentration and the probability of luteinizing hormone (LH) suppression were assessed.

Methods: Children diagnosed with CPP (N = 42 in each dosing cohort), who were treatment naïve or previously treated, received a total of two intramuscular injections of either leuprolide acetate depot 11.25 or 30 mg formulations administered 3 months apart.

Efficacy of Leuprolide Acetate 1-Month Depot for Central Precocious Puberty (CPP): Growth Outcomes During a Prospective, Longitudinal Study.

Introduction: Gonadotropin-releasing hormone analogs (GnRHa) are the treatment of choice for CPP. We investigated growth in GnRHa-naïve subjects, treated with leuprolide acetate 1-month depot for CPP.

Methods: This prospective, open-label study had a long-term, observational, follow-up period.

Validation of the PAGI-SYM and PAGI-QOL among healing and maintenance of erosive esophagitis clinical trial participants.

Background And Aims: Valid instruments are needed to assess important patient-reported outcomes (PROs) in erosive esophagitis (EE).

Methods: Data from 4,092 patients in clinical trials to determine efficacy of dexlansoprazole MR to heal EE and maintain healed EE were used to assess the psychometric properties of the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) and the PAGI-Symptoms Severity Index (PAGI-SYM). A daily diary, gastroesophageal reflux disease (GERD) Symptoms Investigator Assessment and endoscopy results were also used in this study.