Comparison of high-dose finasteride (5 mg/day) versus low-dose finasteride (2.5 mg/day) in the treatment of hirsutism.

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 (n=29) received 2.5 mg finasteride/day and group II (n=27) received 5 mg finasteride/day orally for 1 year. Hirsutism score, body mass index and hormonal parameters (FSH, LH, estradiol, androstenedione, testosterone, free testosterone, 17alpha-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 18.4+/-4.6 to 13.3+/-5.2 (P<0.001) and 18.4+/-4.6 to 8.6+/-4.2 (P<0.001) in group I and from 18.7+/-5.2 to 13.9+/-5.3 (P<0.001) and 18.7+/-5.2 to 10.3+/-5.0 (P<0.001) 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.