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Long-Term Efficacy and Tolerability of Flutamide Combined with Oral Contraception in Moderate to Severe Hirsutism: A 12-Month, Double-Blind, Parallel Clinical Trial

Department of Gynaecology (J.C., J.J.E.), Hospital de la Santa Creu i Sant Pau, 08025 Barcelona, Spain; Department of Gynaecology (E.L.), Hospital Virgen de la Arrixaca, 30120 Murcia, Spain; Department of Gynaecology (A.M.), Hospital Clínico Universitario de Valencia, 46010 Valencia, Spain; Department of Endocrinology (J.A.), Clínica Puerta de Hierro, 28035 Madrid, Spain; Department of Gynaecology (A.F.), Hospital Clínic i Provincial de Barcelona, 08036 Barcelona, Spain; Department of Endocrinology (O.V.), Hospital Juan Canalejo, 15006 La Coruña, Spain; Department of Gynaecology (J.C.), Hospital San Joan de Déu, 08950 Barcelona, Spain; and Department of Endocrinology (F.E.-J., E.T.), Hospital Clínico de Granada, 18012 Granada, Spain

Address all correspondence and requests for reprints to: Dr. Joaquim Calaf, Servicio de Obstetricia y Ginecología, Hospital de la Santa Creu i Sant Pau, Avenida Sant Antoni M^a Claret, 167, 08025 Barcelona, Spain. E-mail: jcalaf{at}hsp.santpau.es.

Objective: Our objective was to test the efficacy and tolerability of three doses of flutamide (125, 250, and 375 mg) combined with a triphasic oral contraceptive (ethynylestradiol/levonorgestrel) during 12 months to treat moderate to severe hirsutism in patients with polycystic ovary syndrome or idiopathic hirsutism.

Design: We conducted a randomized, double-blind, placebo-controlled, parallel clinical trial.

Patients: A total of 131 premenopausal women, suffering from moderate to severe hirsutism, were randomized to placebo or 125, 250, or 375 mg flutamide daily associated with a triphasic oral contraceptive pill. Hirsutism (Ferriman-Gallwey), acne and seborrhea (Cremoncini), and hormone serum levels were monitored at baseline and at 3 (except hormone serum levels), 6, and 12 months. Side effects and biochemical, hematological, and hepatic parameters were assessed.

Methods: We used three-way ANOVA (subject, dose, and visit) with Scheffé adjustment for multiple comparisons or nonparametrical Friedman test and least-squares mean (paired data) and Kruskall-Wallis test for unpaired data analyses. We used ² or Fisher’s test for categorical data.

Results: A total of 119 patients were included in the intention-to-treat analysis. All flutamide doses induced a significant decrease in hirsutism, acne, and seborrhea scores after 12 months compared with placebo without differences among dose levels. Similar related side effects were observed with placebo and 125 mg flutamide (12.5%), and slightly higher with 250 mg (17.3%) and 375 mg (21.2%). No statistically significant differences were observed either among doses or compared with placebo.

Conclusions: Flutamide at 125 mg daily during 12 months was the minimum effective dose to diminish hirsutism in patients with polycystic ovary syndrome or with idiopathic hirsutism.

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