Efficacy and safety of highly purified urinary follicle-stimulating hormone with human chorionic gonadotropin for treating men with isolated hypogonadotropic hypogonadism. European Metrodin HP Study Group.

OBJECTIVE: To assess the efficacy and safety of highly purified urinary FSH in combination with hCG in inducing spermatogenesis in men with primary, complete isolated hypogonadotropic hypogonadism.
DESIGN: Prospective, open, noncomparative, multicenter study.
SETTING: Eight European clinical centers. PATIENT(S): Twenty-eight men with primary, complete isolated hypogonadotropic hypogonadism. INTERVENTION(S): The administration of hCG for 3-6 months followed by the administration of SC highly purified urinary FSH in combination with hCG for 18 months. MAIN OUTCOME MEASURE(S): The primary efficacy end point was a sperm density of at least 1.5 x 10(6) mL. Secondary efficacy end points included mean testicular volume, serum inhibin concentration, semen analysis, and pregnancy in the female partner for couples who desired fertility. Safety was assessed by monitoring adverse events and performing routine laboratory tests. RESULT(S): Twenty-five (89.3%) patients achieved spermatogenesis; 18 (64.3%) achieved a density of >1.5 x 10(6)/mL. All secondary end points were improved. No serious study drug-related adverse events were recorded. CONCLUSION(S): Highly purified urinary FSH in combination with hCG was successful in inducing and maintaining spermatogenesis in men with primary, complete isolated hypogonadotropic hypogonadism. Highly purified urinary FSH administered SC was well tolerated during the treatment period.