Effect of megestrol acetate on uroflow rates in patients with benign prostatic hypertrophy: double-blind study.

Sixty-one patients with benign prostatic hypertrophy (BPH) and decreased maximum and mean urine flow rates were randomly assigned to megestrol (Megace, 120 mg./day) or placebo therapy. The patients were studied over a five-month period with maximal and mean urine flow rates every two weeks. The patients on megestrol demonstrated significant increases in maximum and mean urine flow rates from the sixth through the twentieth weeks compared with their own control baseline values; the placebo-treated patients showed no significant changes in mean flow rates at any time point over the twenty weeks in comparison with their own baseline control values; maximum flow rates in placebo-treated patients did demonstrate statistically significant increases above their own control baseline values at eight, twelve, eighteen, and twenty weeks. Megestrol-treated patients, in comparison with the placebo group, showed statistically significant increases in maximum flow rate at fourteen, sixteen, and twenty weeks after therapy, and statistically significant increases in mean flow rate over the placebo patients at ten, twelve, fourteen, and twenty weeks. Clinical symptoms improved in 78 per cent of the megestrol-treated patients and 57 per cent of the placebo-treated patients. The side effects of megestrol were minimal except for loss of libido in 70 per cent of patients.