Comparison of the clinical efficacy of flutamide and spironolactone plus Diane 35 in the treatment of idiopathic hirsutism: a randomized controlled study.

Author(s): Inal MM, Yildirim Y, Taner CE

Affiliation(s): Social Security Agency, Department of Reproductive Endocrinology and Infertility, Aegean Obstetrics and Gynecology Teaching Hospital, Izmir, Turkey.

Publication date & source: 2005-12, Fertil Steril., 84(6):1693-7.

OBJECTIVE: To compare the effectiveness of flutamide and spironolactone plus Diane 35 in the treatment of idiopathic hirsutism (IH). DESIGN: Prospective randomized clinical study. SETTING: Social Security Agency, Aegean Obstetrics and Gynecology Teaching Hospital, Department of Reproductive Endocrinology and Infertility, a tertiary referral center. PATIENT(S): Eighty women with IH who had been admitted to our center. INTERVENTION(S): Patients were randomly and equally assigned to receive flutamide (250 mg/d for the first 10 days of the cycle) and spironolactone plus Diane 35 (spironolactone 100 mg/d; Diane 35 is a combination tablet of 2 mg cyproterone acetate and 35 microg ethinylestradiol/d) for 9 months. MAIN OUTCOME MEASURE(S): Modified Ferriman-Gallwey (F-G) score and hormonal profile before treatment and at the end of treatment. RESULT(S): In spite of the fact that there were no statistically significant differences in modified F-G scores in between the two groups, a significant decrease in modified F-G scores was observed in the flutamide (from 19.93 +/- 4.31 to 15.58 +/- 4.28) and spironolactone plus Diane 35 (from 18.77 +/- 3.76 to 14.54 +/- 3.29) groups. There were also no differences between the two groups with respect to hormonal profiles including serum FSH, LH, free T, 17-OH-progesterone, and DHEAS levels. No major side effect, including liver toxicity, was observed in either group. CONCLUSION(S): Our data suggest that both therapies have similar effectiveness in the treatment of IH.