Retrospective observational study on the effects and tolerability of flutamide in a large population of patients with various kinds of hirsutism over a 15-year period.

Objective: The aim of the study was to evaluate the long-term effects and tolerability of flutamide in hirsute women. To the best of our knowledge, this study represents the largest report, concerning the population studied and the duration of treatment, in evaluating flutamide use in hirsutism treatment. Design, Patients and Methods: Over the 15-year period which spans from January 1991 to January 2006, a total of 414 premenopausal women with hirsutism of different etiopathogenesis received yearly reducing doses (250, 125 and 62.5 mg/day) of flutamide alone or combined with oral contraceptive for a period varying from at least three years to eight years and more of treatment. Clinical and endocrine evaluations were assessed half-yearly and yearly, respectively, in the first three years of study, and yearly in the following years. Liver function evaluations were quarterly. Results: The both groups of patients under flutamide therapy showed a marked decrease in hirsutism scores after 12 months compared with basal values. The maximum drug effect was after 2 years, and was maintained during the following years of treatment. Androgens were strongly suppressed during treatment. During the first year of treatment 6.0% of patients abandoned the study for hepatic disorders related with the drug. During the following years with the lowest treatment regimen none patient abandoned the study for hepatic discomfort. Conclusions: Flutamide is a satisfactory therapeutic regimen of any form of hirsutism in the long run. Moreover, the use of very low doses of flutamide is associated with minimal side-effects and high compliance.