Objective: A new 3-month depot formulation of 11.25 mg leuprorelin, has been developed recently. The aim of this study was to evaluate the therapeutic bioequivalence of this new formulation compared with that currently used of 3.75 mg leuprorelin 1-month depot for the treatment of central precocious puberty (CPP). Patients and methods: 18 children (17F, 1M) affected by CPP, with onset of pubertal development before the age of 8 yrs in girls and 9 in boys, were included in the trial. At the time of the inclusion the patients were under treatment with montly depot 3.75 mg leuprorelin for 3- 12 months and showed an adequate gonadotropin suppression (peak LH <3IU/L after GnRH test). Seven patients were randomly selected for continuing the therapy with 3.75 mg every 4 weeks and 11 children for therapy with 11.25 mg every 12 weeks, for 1 year period. Results: In patients treated with the 3-month depot formulation the mean peak LH and FSH levels after GnRH test tended to be higher, but not significantly, at 3 months as compared with those obtained with the previous montly formulation in the same patients (LH: 1.69±0.95 IU/L vs 1.29±0.72 IU/L; FSH: 3.30± 1.88 vs 1.73±0.88 IU/L) and in those children continuing the montly formulation (LH 1.06±0.85IU/L; FSH 1.77±0.76 IU/L). The peak FSH and LH decreased thereafter at 6 and 12 months of therapy. Breast stage was unchanged in 7/11 girls treated with the 3-month depot formulation and progressed from the stage B2 to B3 in the remaining 4 cases. No modifications in uterine and ovarian volumes were observed during the study in all patients. Predicted adult height, CA/BA and HA/BA ratios remained unchanged respect to those observed during the previous montly injection treatment in both groups of patients. Conclusion: The 3-month depot formulation of 11.25 mg leuprorelin, efficiently maintains the gonadal suppression induced by 1-month depot formulation. The FSH and LH levels tended to be higher in the first months of therapy compared with those observed during the montly injection regimen but they do not seem influence negatively the patients bone age and predicted adult height in the first year of therapy.
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