Context: Clinical experience is limited regarding the efficacy of different depot Leuprolide acetate (dLA) treatment protocols in girls with central precocious puberty (CPP).
Aim: To compare the 3.75 mg/4 weeks versus 11.25 mg/12 weeks ıntramuscular injection of dLA in suppressing gonadotropins and pubertal development.
Subjects and Methods: In a prospective study, 92 girls with CPP were randomized to receive ıntramuscular dLA 3.75 mg/4 weeks (Group-1, n=47) or 11.25 mg/12 weeks (Group-2, n=45). A GnRH stimulation test was performed before- and at 6 months of treatment to assess gonadotropin suppression. Basal and 40-minute post-dLA gonadotropins and estradiol were measured at the beginning, at the 3rd and 6th month in both groups and, at the 13th injection in Group-1, and at the 4th injection in Group-2. Clinical and anthropometric parameters of pubertal progression, pelvic ultrasound, bone age assessments were performed at the onset and the 12th month of treatment.
Results: There was no difference in clinical, anthropometric, and hormonal characteristics of Group-1 and Group-2 at the initiation of treatment. Serum gonadotropins and pubertal progression were effectively suppressed in both groups. There was no difference in the parameters examined at all time points during treatment between the groups except slight but significantly higher basal LH levels at 3rd (0,61± 0,35 vs 1,0±0,76), and 6th month (0.7± 0.4 vs 0.9 ±0.4) and at the end and of the study (0,7±0,3 vs 0.9± 0.4) in Group-2 (P<0.01). However, mean GnRH-stimulated LH at 6 months or 40-minute post-dLA injection LH at 6th months and at the end of the study did not differ between the groups. Furthermore, Tanner stage of breast development, height SDS, height velocity, bone age advancement, bone age/chronological age ratio, weight SDS, BMI-SDS, uterine and ovarian diameter, and volumes were similar in both groups at the completion of the study. No significant side effects were observed in both groups.
Conclusion: Although basal LH levels are slightly higher in 11.25 mg/4weeks dose, stimulated LH levels and clinical parameters of pubertal suppression are similar during the first year of dLA treatment with 3.75 mg/4 weeks or 11.25 mg/12 weeks doses. The latter offers the further advantage of less injection numbers in treatment of CPP.
21 Sep 2023 - 23 Sep 2023