Abstract

In treating central precocious puberty, the monthly formulations of gonadotropin-releasing hormone agonists are the main formulations that have been used. Triptorelin is a gonadotropinreleasing hormone agonist and is approved to be used in central precocious puberty as a 1 mo formulation. This study aimed to compare the efficacy and adverse effects of a subcutaneous formulation of Triptorelin (Varipeptyl) with Diphereline during a double-blinded randomized clinical trial. Girls with idiopathic central precocious puberty were randomly allocated to Group A (intramuscular injection of Diphereline 3.75 mg, IPSEN, France) and Group B (subcutaneously injection of Variopeptyl 3.75 mg, Varian Pharmed, Iran) repeated every 28 d for 3 mo. Hormonal changes, also adverse effects and efficacy endpoints were measured at baseline and mo 3. Out of 35 girls with confirmed central precocious puberty, 18 cases were assigned to take Diphereline (group A) and 17 cases to take Variopeptyl (group B). Mean level of estradiol had a decrease of 31.7±11 pg /ml (p value: 0.00) in group A and 27.3±10 pg /ml (p value: 0.00) in group B. The mean luteinizing hormone’s level reduced 3/1±2/3 IU/L (p value: 0.00) in group A and 1.6±0.9 IU/L (p value: 0.00) in group B. No significant side effects were seen. 3 patients in group B had nodules at the injection site and one patient in each group had minimal vaginal bleeding. This study demonstrated that the efficacy of Variopeptyl is as same as Diphereline in suppressing the hypothalamic-pituitarygonadal axis and can be a substitute for Diphereline.