A comparison between two doses of flutamide (250 mg/d and 500 mg/d) in the treatment of hirsutism

Abstract

Objective: To compare the effects of flutamide at 250 mg/d and 500 mg/d in the treatment of hirsutism. Design: Randomized, prospective clinical study. Patient(s): Sixty-five patients with moderate to severe hirsutism. Intervention(s): Group I (n = 35) patients were treated with flutamide, 250 mg/d, and group II (n = 30) patients were treated with flutamide, 500 mg/d, for 12 months. Baseline hormone levels, body mass index, and hirsutism scores were similar between the groups. Hirsutism score, hormone levels, and multiscreen blood chemistry were measured at 3-month intervals for 12 months. Result(s): The modified Ferriman-Gallwey scores for hirsutism decreased significantly at months 6 and 12 from a mean ± SEM of 17.8 ± 0.9 to 6.0 ± 0.6 ( P < 0.001) and 17.8 ± 0.9 to 4.8 ± 0.7 ( P < 0.001) in group I and from 17.0 ± 0.9 to 6.6 ± 0.7 and 17.0 ± 0.9 to 5.2 ± 0.7 ( P < 0.001) in group II, respectively. The reductions in hirsutism scores (mean ± SEM) were similar in group I at 6 months (64.6% ± 2.5%) and at 12 months (71.2% ± 2.2%) and in group II at 6 months (62.1% ± 3.0%) and at 12 months (70.3% ± 3.0%). The percent reductions in hirsutism scores at 6 and at 12 months were similar within group I (64.6% ± 2.5% and 71.2% ± 2.2%) and group II (62.1% ± 3.0% and 70.3% ± 3.0%), respectively. The decreases in hirsutism scores in the first 6 months were more significant than in the last 6 months of treatment in both groups. There were no significant differences in any of the hormone levels during therapy in either group. One patient in group II was excluded from the study because of liver dysfunction. Conclusion(s): This study shows that two different doses of flutamide (250 mg/d and 500 mg/d) are similarly effective in reducing hair growth. Flutamide at a dose of either 250 mg/d or 500 mg/d has no further effect after 6 months. We conclude that if flutamide is administered at a dose of 250 mg/d it may represent an effective and well tolerated treatment with reduced cost for the patient.