Placebo-controlled double-blind study in human benign obstructive prostatic hypertrophy with flutamide.

A double placebo-controlled study using the anti-androgen non-steroidal compound Flutamide in 32 patients with benign enlargement of the prostate is reported. A statistical analysis of the results showed no difference between the group treated with Flutamide and the group receiving the placebo, except in as far as 'the size' of the prostate was concerned. We observed a significant reduction of the latter in patients receiving Flutamide. The different problems produced by the choice and the measure of parameters in this type of investigation have been discussed.