Objective: To compare the clinical efficacy and safety of high-dose (5 mg/day) and low-dose (2.5 mg/ day) finasteride in the treatment of hirsutism in women. Design: A prospective, randomized and controlled clinical trial. Methods: Fifty-six hirsute women with moderate to severe hirsutism were prospectively evaluated to see the effects of low-dose (2.5 mg/day) and high-dose (5 mg/day) finasteride. Patients were randomly divided into two treatment groups. Group I ðn ¼ 29Þ received 2.5 mg finasteride/day and group II ðn ¼ 27Þ received 5 mg finasteride/day orally for 1 year. Hirsutism score, body mass index and hormonal parameters (FSH, LH, estradiol, androstenedione, testosterone, free testosterone, 17a-hydroxyprogesterone, dehydroepiandrosterone sulfate and sex hormone-binding globulin) were measured in all the patients before treatment and repeated at six-monthly intervals. Results: The hirsutism scores decreased significantly at months 6 and 12 from a mean^S.D. of 18:44 :6 to 13:3^5:2 ðP , 0:001Þ and 18:4^4:6 to 8:6^4:2 ðP , 0:001Þ in group I and from 18:7^5:2 to 13:9^5:3 ðP , 0:001Þ and 18:7^5:2 to 10:3^5:0 ðP , 0:001Þ in group II respectively. No significant changes in the blood chemistry and hormonal parameters except estradiol levels were observed. No serious side-effects were seen in the two groups. In group II, estradiol levels increased significantly at 6 and 12 months. Conclusions: In this study, hirsutism scores decreased significantly at 6 and 12 months in both groups I and II. Low-dose (2.5 mg/day) finasteride is safe and cost effective in the treatment of hirsutism and may be used instead of high-dose finasteride (5 mg/day) therapy.

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