Study 2

TITLE
Comparison of flutamide and spironolactone in the treatment of hirsutism: a randomized controlled trial [see comments]

AUTHOR
Cusan L; Dupont A; Gomez JL; Tremblay RR; Labrie

ORGANISATION
Medical Research Council Group in Molecular Endocrinology, Centre Hospitalier, Universite Laval Research Center, Quebec, Canada.

SOURCE
Fertil Steril 1994 Feb; 61 (2): 281-7

LANGUAGE OF PUBLICATION
English

ABST: OBJECTIVE:
To compare the clinical efficacy and safety of the pure antiandrogen flutamide and the steroidal derivative spironolactone in the treatment of hirsutism in women.

DESIGN:
Fifty-three premenopausal women suffering from moderate to severe hirsutism were randomized into two groups and received either flutamide or spironolactone in association with a triphasic oral contraceptive (OC) pill. Hirsutism, acne, seborrhea, alopecia, and side effects were monitored monthly for a treatment period of 9 months and a follow-up after treatment period of 6 months. Blood samples were taken at each visit for assessment of endocrine, biochemical, and hematologic parameters.

RESULTS:
After only 6 months of therapy, flutamide caused a maximal reduction in the hirsutism score to a value within almost normal range; during the same period, spironolactone caused only a 30% reduction of the hirsutism score. Whereas flutamide caused a dramatic (80%) decrease in total acne, seborrhea, and hair loss score after only 3 months of therapy, spironolactone caused only a 50% reduction in acne and seborrhea, with no significant effect on the hair loss score. Four patients in the spironolactone group but only one in the flutamide group stopped the medication because of adverse side effects.

CONCLUSION: The present data obtained in a randomized prospective study clearly demonstrate that the pure antiandrogen flutamide is superior to spironolactone in the treatment of female hirsutism and its related androgen-dependent symptoms and signs in women. (AUTHOR)

MJTR: Flutamide TU. Hirsutism DT.

MNTR: Adult. Comparative Study. Estradiol BL. Female. Flutamide AE. FSH BL. Human. LH BL. Prasterone AA. Prasterone BL. Premenopause. Progesterone BL. Spironolactone AE. Spironolactone TU. Support, Non-U.S. Gov’t. Testosterone BL. CLINICAL TRIAL. JOURNAL ARTICLE. RANDOMIZED CONTROLLED TRIAL

RNUM: 13311-84-7 (Flutamide); 50-28-2 (Estradiol); 52-01-7 (Spironolactone); 53-43-0 (Prasterone); 57-83-0 (Progesterone); 57-85-2 (Testosterone); 651-48-9 (dehydroepiandrosterone sulfate); 9002-67-9 (LH); 9002-68-0 (FSH)

GEOT: UNITED STATES

IDEN: ISSN: 0015-0282. JOURNAL-CODE: EVF. ENTRY-DATE: 940310. JOURNAL-SUBSET: M. IM-DATE: 9405.

ACCE: 94131082