Objective: To evaluate the long-term safety and tolerability of flutamide therapy for hirsutism.
Design: Prospective observational study.
Setting: Gynecology department in a teaching hospital.
Patient(s): Hyperandrogenic women presenting for hirsutism treatment were followed between January 2000 and January 2007.
Intervention(s): Women received flutamide 250 mg/day alone (n = 27) or combined with a fixed dose of an oral contraceptive containing 0.020 mg of ethinyl estradiol (EE) and 0.15 mg of desogestrel (n = 56).
Main outcome measure(s): Adverse events, safety, tolerability and efficacy were assessed every 6 months during the follow-up. Liver and lipid profiles were also recorded.
Result(s): Patients under flutamide therapy showed, compared with basal values, a significant progressive decrease in hirsutism scores after 6 months of treatment with a maximum effect at 12 months that was maintained during the 84 months of follow-up. A total of 40.96% women presented one or more adverse effects during the follow-up; 33.73% showed at least one adverse effect possibly related with the study drug, and 24.09% withdrew from the study because of adverse effects. During the follow-up, as many as 59% of patients abandoned the study.
Conclusion(s): Flutamide is very effective for hirsutism treatment; however, adverse effects are very frequent and associated with low long-term compliance.