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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.
J Clin Endocrinol Metab. 2007 Sep; 92(9):3446-52.JC

Abstract

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.

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Authors+Show Affiliations

Calaf J
Servicio de Obstetricia y Ginecología, Hospital de la Santa Creu i Sant Pau, Avenida Sant Antoni M Claret, 167, 08025 Barcelona, Spain. jcalaf@hsp.santpau.es
López E
No affiliation info available
Millet A
No affiliation info available
Alcañiz J
No affiliation info available
Fortuny A
No affiliation info available
Vidal O
No affiliation info available
Callejo J
No affiliation info available
Escobar-Jiménez F
No affiliation info available
Torres E
No affiliation info available
Espinós JJ
No affiliation info available
Spanish Working Group for Hirsutism
No affiliation info available

MeSH

Acne VulgarisAdolescentAdultAndrogen AntagonistsContraceptives, Oral, HormonalDermatitis, SeborrheicDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleFlutamideHirsutismHumansPlacebosTime FactorsTreatment Outcome

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17566093

Citation

Calaf, J, 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." The Journal of Clinical Endocrinology and Metabolism, vol. 92, no. 9, 2007, pp. 3446-52.
Calaf J, López E, Millet A, 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;92(9):3446-52.
Calaf, J., López, E., Millet, A., Alcañiz, J., Fortuny, A., Vidal, O., Callejo, J., Escobar-Jiménez, F., Torres, E., & Espinós, J. J. (2007). Long-term efficacy and tolerability of flutamide combined with oral contraception in moderate to severe hirsutism: a 12-month, double-blind, parallel clinical trial. The Journal of Clinical Endocrinology and Metabolism, 92(9), 3446-52.
Calaf J, 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;92(9):3446-52. PubMed PMID: 17566093.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term efficacy and tolerability of flutamide combined with oral contraception in moderate to severe hirsutism: a 12-month, double-blind, parallel clinical trial. AU - Calaf,J, AU - López,E, AU - Millet,A, AU - Alcañiz,J, AU - Fortuny,A, AU - Vidal,O, AU - Callejo,J, AU - Escobar-Jiménez,F, AU - Torres,E, AU - Espinós,J J, AU - ,, Y1 - 2007/06/12/ PY - 2007/6/15/pubmed PY - 2007/11/2/medline PY - 2007/6/15/entrez SP - 3446 EP - 52 JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 92 IS - 9 N2 - 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. SN - 0021-972X UR - https://www.unboundmedicine.com/medline/citation/17566093/Long_term_efficacy_and_tolerability_of_flutamide_combined_with_oral_contraception_in_moderate_to_severe_hirsutism:_a_12_month_double_blind_parallel_clinical_trial_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2006-2798 DB - PRIME DP - Unbound Medicine ER -