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.


METHODS
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.
Bayram
Fahri
F
Department of Endocrinology and Metabolism, Faculty of Medicine, Erciyes University, Kayseri, Turkey. fbayram@erciyes.edu.tr
Müderris
I Ipek
II
Güven
Muhammed
M
Keleştimur
Fahrettin
F
D019326:17-alpha-Hydroxyprogesterone / Q000097:blood; D000293:Adolescent; D000328:Adult; D000735:Androstenedione / Q000097:blood; D019314:Dehydroepiandrosterone Sulfate / Q000097:blood; D004791:Enzyme Inhibitors / Q000008:administration & dosage*; D004958:Estradiol / Q000097:blood; D005260:Female; D018120:Finasteride / Q000008:administration & dosage*; D005640:Follicle Stimulating Hormone / Q000097:blood; D006628:Hirsutism / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007986:Luteinizing Hormone / Q000097:blood; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D013739:Testosterone / Q000097:blood
D004791:Enzyme Inhibitors; D012738:Sex Hormone-Binding Globulin; D013739:Testosterone; D000735:Androstenedione; D004958:Estradiol; D019314:Dehydroepiandrosterone Sulfate; D018120:Finasteride; D019326:17-alpha-Hydroxyprogesterone; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone