Long-term safety and tolerability of flutamide for the treatment of hirsutism.
OBJECTIVE
To evaluate the long-term safety and tolerability of flutamide therapy for hirsutism.


METHODS
Prospective observational study.


METHODS
Gynecology department in a teaching hospital.


METHODS
Hyperandrogenic women presenting for hirsutism treatment were followed between January 2000 and January 2007.


METHODS
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).


METHODS
Adverse events, safety, tolerability and efficacy were assessed every 6 months during the follow-up. Liver and lipid profiles were also recorded.


RESULTS
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.


CONCLUSIONS
Flutamide is very effective for hirsutism treatment; however, adverse effects are very frequent and associated with low long-term compliance.
Castelo-Branco
Camil
C
Faculty of Medicine-University of Barcelona, Institut Clinic of Gynecology, Obstetrics and Neonatology, Hospital Clinic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain. castelobranco@ub.edu
Moyano
Dolores
D
Gómez
Olga
O
Balasch
Juan
J
D000328:Adult; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D003278:Contraceptives, Oral, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D017135:Desogestrel / Q000008:administration & dosage / Q000009:adverse effects; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005485:Flutamide / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006628:Hirsutism / Q000188:drug therapy*; D006801:Humans; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000726:Androgen Antagonists; D003278:Contraceptives, Oral, Hormonal; D004997:Ethinyl Estradiol; D005485:Flutamide; D017135:Desogestrel