Calaf, JLópez, EMillet, AAlcañiz, JFortuny, AVidal, OCallejo, JEscobar-Jiménez, FTorres, EEspinós, J J2012-12-032012-12-032007-09Calaf J, López E, Millet A, Alcañiz J, Fortuny A, Vidal O, et al. Long-term efficacy and tolerability of flutamide combined with oral contraception in moderate to severe hirsutism: a 12-month, double-blind, parallel clinical trial. J. Clin. Endocrinol. Metab.. 2007 Sep; 92(9):3446-52http://hdl.handle.net/10668/684Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;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 chi(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.enAcné VulgarAdolescenteAdultoAntagonistas de AndrógenosAnticonceptivos Hormonales OralesDermatitis SeborreicaRelación Dosis-Respuesta a DrogaMétodo Doble CiegoEsquema de MedicaciónQuimioterapia CombinadaFemeninoFlutamidaHirsutismoHumanosPlacebosFactores de TiempoResultado del TratamientoMedical Subject Headings::Named Groups::Persons::Age Groups::AdolescentMedical Subject Headings::Named Groups::Persons::Age Groups::AdultMedical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Reproductive Control Agents::Contraceptive Agents::Contraceptive Agents, Female::Contraceptives, Oral::Contraceptives, Oral, HormonalMedical Subject Headings::Diseases::Skin and Connective Tissue Diseases::Skin Diseases::Dermatitis::Dermatitis, SeborrheicMedical Subject Headings::Phenomena and Processes::Physiological Phenomena::Pharmacological Phenomena::Dose-Response Relationship, DrugMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Methods::Research Design::Double-Blind MethodMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration ScheduleMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Therapy, CombinationMedical Subject Headings::Check Tags::FemaleMedical Subject Headings::Chemicals and Drugs::Organic Chemicals::Amides::Anilides::FlutamideMedical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Virilism::HirsutismMedical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::HumansMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::PlacebosMedical Subject Headings::Phenomena and Processes::Physical Phenomena::Time::Time FactorsMedical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment OutcomeMedical Subject Headings::Diseases::Skin and Connective Tissue Diseases::Skin Diseases::Acneiform Eruptions::Acne VulgarisMedical Subject Headings::Chemicals and Drugs::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormone Antagonists::Androgen Antagonistsresearch article17566093open access10.1210/jc.2006-27980021-972X