Phase 3 trial of a small volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty
Journal of Clinical Endocrinology and Metabolism Aug 05, 2020
Klein KO, Freire A, Gryngarten MG, et al. - Researchers conducted this phase 3 multicenter, open-label, single-arm study to determine effectiveness, pharmacokinetics, and safety of 6-month 45 mg subcutaneous leuprolide acetate for central precocious puberty (CPP). Sixty-four GnRHa naive children with CPP (age: 7.5 ± 0.1 years) received study drug: 59 completed the study. Interventions included 2 doses of 45 mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks, children followed for 48 weeks. According to results, 54/62 (87%) children achieved post-stimulation LH < 4 IU/L at week 24. At a 6-month interval, a small volume of 45 mg subcutaneous leuprolide acetate administered effectively inhibited pubertal hormones and stopped or caused the regression of pubertal progression. For children with CPP, this long-acting GnRHa preparation of leuprolide acetate is a new effective and well-tolerated treatment. Adverse events were mild and did not lead to discontinuation of the treatment.
-
Exclusive Write-ups & Webinars by KOLs
-
Daily Quiz by specialty
-
Paid Market Research Surveys
-
Case discussions, News & Journals' summaries