ABSTRACT
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.
