Prospective Cohort Study on the Effects and Tolerability of Flutamide in Patients with Female Pattern Hair Loss

Roberto Paradisi, MD; Eleonora Porcu, MD; Raffaella Fabbri, BSc; Renato Seracchioli, MD; Cesare Battaglia, MD; Stefano Venturoli, MD


The Annals of Pharmacotherapy. 2011;45(4):469-475. 

In This Article

Abstract and Introduction


Background: Flutamide has been rarely used for the treatment of female pattern hair loss (FPHL). Flutamide treatment for FPHL has not been evaluated in long-term studies with sufficiently large numbers of women.
Objective: To evaluate long-term effects, safety, and tolerability of flutamide in women with FPHL.
Methods: A prospective cohort study was conducted in our tertiary care university hospital. The cohort included 101 women diagnosed with FPHL from January 1991 to January 2006. These women received yearly reducing doses (250, 125, and 62.5 mg/day) of flutamide for 4 years. The cohort included 33 patients treated with flutamide alone and 68 treated with flutamide combined with an oral contraceptive. Clinical and endocrine evaluations were assessed semiannually and annually, respectively, in the first 3 years of the study, and once in the following year. Liver function was evaluated quarterly.
Results: Both groups showed a marked decrease in alopecia scores after 12 months of flutamide therapy, compared with baseline values. The maximum drug effect occurred after 2 years and was maintained during the following 2 years of treatment. Androgens were strongly suppressed. During the first year of treatment, 4% of patients abandoned the study due to hepatic disorders related to the drug. During the following years, with the lower treatment regimen, no patient abandoned the study because of hepatic alterations.
Conclusions: Flutamide is a satisfactory therapeutic regimen for treatment of FPHL in the long run. Moreover, the use of very low doses (62.5 mg/day) of flutamide is associated with complete hepatic tolerability and high adherence.


Female pattern hair loss (FPHL) (female androgenetic alopecia) is a common and puzzling condition in women. It is defined as a progressive, diffuse, and symmetric loss of scalp hair due to a combination of genetic predisposition and increased response of hair follicles to androgens.[1] As with hair loss in men, FPHL begins in early adulthood (ages 20-40 years), occurs as often as in men (30–50% of women) but with less severe hair loss, and is diffuse although more marked on the fronto-central area of the scalp.[1–3] A model for the pathogenesis of FPHL must account for the stepwise miniaturization of hair follicles; alteration of hair cycle dynamics, with increased telogen to anagen hair ratio for a progressively shorter anagen phase; systemic and local effects of androgens in promoting the condition; and familial nature of the condition.[2,4] Psychological problems, including stress and depression, altered diet and lifestyles, and thyroid disorders, may also be considered as relevant comorbid conditions. Asian and black populations have a lower prevalence than whites.[5] Androgen therapy may cause iatrogenic hair loss in women.[6]

Considering that hair has essential psychosocial importance in our society, resulting in distress for patients,[7] the demand for drugs that alter hair growth and appearance has led to a multibillion dollar industry.[8] Few drugs that are effective for FPHL are available. The most used are cyproterone acetate,[9–11] spironolactone,[11–13] finasteride,[10,14,15] and minoxidil,[16–18] all with evident but modest, nondefinitive, and often conflicting outcomes.

Flutamide, 2-methyl-N-[4-nitro-3-(trifluoromethyl) phenyl] propanamide, is commonly defined as a pure selective antiandrogen with a nonsteroidal structure devoid of any other hormonal or antihormonal activity[19] and acts mainly at the peripheral level, competitively blocking the cytoplasmatic and nuclear binding of androgens to the receptor.[20,21] It has been used rarely as therapy for FPHL and, in particular, has been reported in only 1 article on the treatment of alopecia as a primary disorder,[10] and in another report, alopecia was only a secondary efficacy endpoint, in addition to hirsutism.[22]

Our primary objective was to evaluate the effects of flutamide in the treatment of FPHL, comparing pre- and duringtreatment conditions; we also attempted to verify whether the addition of an oral contraceptive to flutamide therapy could eventually further improve outcomes. To our knowledge, this is the most comprehensive report on use of flutamide in this population and the duration of treatment.


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