ESPE Abstracts (2018) 89 RFC10.2

Non-Inferiority Clinical Trial on Gonadotropinversus Pulsatile Gonadotropin-Releasing Hormone Infusion Therapy in Male Adolescent Patient Withcongenital Hypogonadotropic Hypogonadism

Ying Liu & Chunxiu Gong


Capital Medical University Affiliated Beijing Children Hospital, Beijing, China


Context: We investigate the efficacy and safetyof non-inferiority clinical trial for human chorionic gonadotropin/ human menopaousal gonadotropin (HCG/HMG) versus pulsatile gonadotropin-releasing hormone (GnRH) which have not been evaluated 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).

Methods: For this prospective cohort nonrandomized controlled study, a total of 43 male adolescent CHH patients were recruited and categorized into HCG/HMG (group 1, n=20) and GnRH (group 2, n=23) groups. All patients were treated for 3–12 months. Testicular volume (TV), penile length (PL), blood sex hormones levels, height, body weight, and other related laboratory indices were measured and evaluated. And then, when alpha =0.05, take the 3 month growth differential (2 ml) between group 1 and group 2 as non-inferior validity boundary value (δ) and conduct independent sample t test.

Results: All CHH patients were treated for over 3 months. At the beginnig, 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±1.4 ml VS 2.7±1.5 ml, 4.8±1.3 cm VS 4.2±1.4 cm and 1.6±0.4 cm vs 1.5±0.4 cm. 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 4.6±2.2 ml VS 4.6±2.7 ml, 6.1±1.3 cm VS 5.1±1.6 cm, 2.7±2.7 ml vs 2.0±2.2 ml, 1.3±1.0 cm vs 1.0±0.8 cm and 0.9±0.9 cm vs 0.4±0.4 cm. The difference of two groups was not statistically significant. There was no significant difference in height, body weight, or BMI between the two treatments. There was no significant difference in efficacy comparison in both groups after 6–12 months treatment. There was no significant difference in side effects in both groups.

Conclusions: Adolescents patients with CHH may be effectively treated with HCG/HMG and GnRH. We discoverd that the effect of HCG/HMG was as good as GnRH in treating adolescent boys with CHH.

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