OBJECTIVE: To compare the efficacy and safety of recombinant human FSH (r-hFSH) and hCG treatment for male hypogonadotropic hypogonadism (HH) in different populations and to identify characteristics predictive of spermatogenesis. DESIGN: A combined analysis of data from four clinical trials. SETTING: Phase III, open-label, noncomparative studies with similar designs conducted in Australia, Europe, Japan, and the United States. PATIENT(S): One hundred men with complete idiopathic or acquired HH. INTERVENTION(S): Pretreatment with hCG for 3-6 months, followed by combination therapy with hCG and r-hFSH (150 IU three times weekly) for up to 18 months. Doses of r-hFSH were adjusted according to spermatozoa count until the maximum dose was reached. MAIN OUTCOME MEASURE(S): The primary efficacy endpoint was a spermatozoa concentration of >or=1.5 x 10(6)/mL. RESULT(S): A total of 81 men remained azoospermic but achieved normal serum T concentrations after hCG pretreatment. Of these, 68 (84.0%) achieved spermatogenesis and 56 (69.1%) achieved spermatozoa concentrations >or=1.5 x 10(6)/mL. Large baseline mean testicular volume, low body mass index, and advanced sexual maturity were predictors of good response to therapy. Similar treatment responses were observed across different study populations. CONCLUSION(S): R-hFSH (combined with hCG) is effective for the restoration of fertility in the majority of men with HH.
OBJECTIVE: To compare the efficacy and safety of recombinant human FSH (r-hFSH) and hCG treatment for male hypogonadotropic hypogonadism (HH) in different populations and to identify characteristics predictive of spermatogenesis. DESIGN: A combined analysis of data from four clinical trials. SETTING: Phase III, open-label, noncomparative studies with similar designs conducted in Australia, Europe, Japan, and the United States. PATIENT(S): One hundred men with complete idiopathic or acquired HH. INTERVENTION(S): Pretreatment with hCG for 3-6 months, followed by combination therapy with hCG and r-hFSH (150 IU three times weekly) for up to 18 months. Doses of r-hFSH were adjusted according to spermatozoa count until the maximum dose was reached. MAIN OUTCOME MEASURE(S): The primary efficacy endpoint was a spermatozoa concentration of >or=1.5 x 10(6)/mL. RESULT(S): A total of 81 men remained azoospermic but achieved normal serum T concentrations after hCG pretreatment. Of these, 68 (84.0%) achieved spermatogenesis and 56 (69.1%) achieved spermatozoa concentrations >or=1.5 x 10(6)/mL. Large baseline mean testicular volume, low body mass index, and advanced sexual maturity were predictors of good response to therapy. Similar treatment responses were observed across different study populations. CONCLUSION(S): R-hFSH (combined with hCG) is effective for the restoration of fertility in the majority of men with HH.
Authors: A A Sinisi; D Esposito; G Bellastella; L Maione; V Palumbo; L Gandini; F Lombardo; A De Bellis; A Lenzi; A Bellastella Journal: J Endocrinol Invest Date: 2010-04-30 Impact factor: 4.256
Authors: A Lenzi; G Balercia; A Bellastella; A Colao; A Fabbri; C Foresta; M Galdiero; L Gandini; C Krausz; G Lombardi; F Lombardo; M Maggi; A Radicioni; R Selice; A A Sinisi; G Forti Journal: J Endocrinol Invest Date: 2009-12-01 Impact factor: 4.256