ESPE2021 Free Communications Neuroendocrinology (6 abstracts)
Efficacy and Safety of Corifollitropin Alfa in Combination with Human Chorionic Gonadotropin for Initiation or Restoration of Puberty in Adolescent Males Aged 14 to < 18 Years with Hypogonadotropic Hypogonadism
R. Ravi Shankar 1 , Suneri Shah 1 , Hee-Koung Joeng 1 , Geraldine Mendizabal 1 , Yanfen Guan 1 , Barbara J. Stegmann 2 , Eberhard Nieschlag 3 , Hermann M. Behre 4 , Ronald S. Swerdloff 5 , Michelle C. Fox 1 & Keith D. Kaufman 1
1Merck & Co., Inc., Kenilworth, USA.;2Organon & Co, Jersey City, USA.;3Center for Reproductive Medicine and Andrology, University of Munster, Munster, Germany.;4Center for Reproductive Medicine and Andrology, Martin Luther University Halle-Wittenberg, Halle, Germany.;5David Geffen School of Medicine at UCLA, The Lundquist Institute at Harbor-UCLA Medical Center, Torrance, USA
Background: Combinations of follicle-stimulating hormone (FSH) and human chorionic gonadotropin (hCG) have been successful in treating males with hypogonadotropic hypogonadism (HH). The aim of this study was to investigate the efficacy and safety of corifollitropin alfa (CFA), a long-acting FSH analog, combined with hCG to induce testicular growth and pubertal development in adolescent males with HH.
Methods: This was a 64-week, multi-center, open label, single-arm study of CFA in males 14 to <18 years of age with HH (n = 17). After a 12-week priming period with CFA (100 μg if weight ≤60 kg, or 150 μg if weight >60 kg) given subcutaneously (SC) every other week (EOW), participants entered a 52-week combined treatment period with CFA EOW + SC hCG twice-weekly (dose adjusted between 500 IU and 5,000 IU to keep total testosterone [T] and estradiol levels within acceptable ranges). The primary efficacy endpoint was change from baseline at Week 64 (overall treatment period) in testicular volume (TV), measured as the sum of volumes of left and right testes by ultrasound. Efficacy analyses were based on the Full Analysis Set population (n = 13), which included all participants who had a baseline and at least 1 post-baseline TV measurement, had LH levels ≤3 IU/L, had received treatment for at least 12 weeks with CFA followed by at least 24 weeks of CFA + hCG, and had ≤4 weeks between the last dose of CFA and the last endpoint measurement. Safety was evaluated by the presence of anti-CFA antibodies and the occurrence of adverse events.
Results: In the CFA priming period, mean TV increased (geometric mean [95% CI] fold increase from baseline at Week 12: 1.83 [1.58, 2.13]) and continued to increase during the combined treatment period (geometric mean [95%CI] fold increase from baseline at Week 64: 9.43 [7.44, 11.97]). Increases in serum T were noted and participants progressed through puberty (assessed by Tanner stages and growth velocity). Changes in serum inhibin-B and anti-Mullerian hormone levels were consistent with the initiation and progression of puberty. Treatment was generally well tolerated. No participant developed anti-CFA antibodies.
Conclusions: In adolescent males with HH, treatment with CFA (alone for 12 weeks and then combined with hCG from Weeks 12 to 64) was generally well tolerated and induced testicular growth and pubertal development.
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