MON-LB051 Non-inferiority Clinical Trial on Gonadotropinversus Pulsatile Gonadotropin-releasing Hormone Infusion Therapy in Male Adolescent Patient with Congenital Hypogonadotropic Hypogonadism

Abstract

Context We investigate the efficacy and safety of non-inferiority clinical trial for human chorionic gonadotropin/ human menopausal gonadotropin (HCG/HMG) versus pulsatile gonadotropin-releasing hormone (GnRH) which has not been evaluated on non-inferiority clinical trial in puberty boys with CHH. Objective To compare the efficacy and security of two different treatments in male adolescent patient with congenital hypogonadotropic hypogonadism (CHH) . To explore the standardization of early treatment and it is possible clinical recommended regimen. Methods For this prospective cohort nonrandomized controlled study, male adolescent CHH patients were recruited and categorized into HCG/HMG(group 1) and GnRH (group 2) groups. All patients were treated for 3-12months. The study was divided into research period (3 months of treatment) and extension period (3 to 12 months of treatment). Testicular volume (TV), penile length(PL), blood sex hormones levels, height, body weight, and other related laboratory indices were measured and evaluated. In this study, we observe the therapeutic effect within 3 months and also collect partial extended period data for providing further research experience. Results All CHH patients were treated for over 3 months. At the beginning, the average age of patients, the testicular volume, penile length, penile diameter in group 1 and group 2 were 15.3±1.9 years VS 14.2±1.5 years, 2.5±1.4ml VS 2.7±1.5ml, 4.8±1.3cm VS 4.2±1.4cm and 1.6±0.4cm VS 1.5±0.4cm. The difference of two groups was not statistically significant. After 3 months treatment, the testicular volume, penile length, penile diameter, the growth of testicular volume, the growth of penile length and the growth of penile diameter in group 1 and group 2 were 5.1±2.7ml VS 4.6±2.7ml , 6.9±1.7cm VS 5.1±1.6cm, 2.5±0.5cm VS 1.9±0.6cm,2.0±1.6 cm 和1.0±0.8cm, 0.9±0.5cmand0.3±0.4cm. The difference of two groups was not statistically significant. There was no significant difference in height, body weight, or BMI between the two treatments. Based on the principles of hypothesis-test, mean value M-0.25625, standard error(SE) = 0.69319,M±1.96, Se=-0.25625±1.3586524,(-1.161,1.10). The growth differential of testicular volume between group 1 and group 2 was less than 2ml in (P<0.05) . It can be inferred that group 1 is not inferior to group 2. There was no significant difference in efficacy comparison in some of the patients were treated after 6-12 months in both groups. There was no significant difference in side effects in both groups. Conclusions In this clinical trial, 3 months was an observation period. Short-term therapeutic indicated adolescent patients with CHH were effectively treated with HCG/HMG and GnRH. We discovered that the effect of HCG/HMG was as good as GnRH in treating adolescent boys with CHH. This therapeutic schedule can be used in more patients. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.