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.


METHODS
Prospective, open, noncomparative, multicenter study.


METHODS
Eight European clinical centers.


METHODS
Twenty-eight men with primary, complete isolated hypogonadotropic hypogonadism.


METHODS
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
D000293:Adolescent; D000328:Adult; D006063:Chorionic Gonadotropin / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D005640:Follicle Stimulating Hormone / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use* / Q000652:urine; D006801:Humans; D007006:Hypogonadism / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009845:Oligospermia / Q000188:drug therapy* / Q000209:etiology; D011247:Pregnancy; D018873:Pregnancy Rate; D011446:Prospective Studies; D013076:Sperm Count / Q000187:drug effects
D006063:Chorionic Gonadotropin; D005640:Follicle Stimulating Hormone