Comparison of the clinical efficacy and safety of flutamide versus flutamide plus an oral contraceptive in the treatment of hirsutism.

Objective: To compare the clinical, hormonal, biochemical and hemotological effects of flutamide versus flutamide plus an oral contraceptive (OC) in the treatment of hirsutism.

Patients: Eighty-four women with hirsutism were equally randomized to receive either flutamide or flutamide plus OC.

Design: Eighty-four women with hirsutism were recruited from patients presenting to our hospital. Each patient underwent a complete medical and gynecological examination as well as blood cell counts, biochemical and endocrine profiles. Hirsutism scores and laboratory tests were done during the 1st, 3rd and 6th months of therapy. Thirty-seven women in the flutamide group (taking 250 mg flutamide per day) and 32 women in the flutamide plus OC group (taking 250 mg flutamide plus 35 microg ethinyl estradiol and 2 mg cyproterone acetate per day) regularly followed the therapy regimens.

Results: There were no significant differences in Ferriman-Gallway scores at the beginning and at the end of the therapies between the two groups (p > 0.05). At the 6th month, the decreases in Ferriman-Gallway scores were significant in both flutamide (from 18.95 +/- 4.44 to 14.46 +/- 5.02; p < 0.05) and flutamide plus OC groups (from 19.94 +/- 4.31 to 15.58 +/- 4.28; p < 0.05). In the first group, 2 of 6 oligomenorrheic women had regular cycles at the end of the therapy. Oligomenorrhea in 8 women was all changed to regular cycles in the flutamide plus OC group. Regarding the hormonal profile, only in the second group were prolactin, free testosterone and dehydroepiandrosterone sulfate levels significantly decreased (p < 0.05). Hepatic function tests were significantly increased in both groups, but they were all within normal ranges.

Conclusion: These data suggest that both therapies were similarly effective and safe in the treatment of hirsutism. In women with oligomenorrhea and/or needing contraception, adding an OC shows better results than flutamide treatment alone in providing regular cycles.