Clinical studies with finasteride in women

Finasteride is not indicated for use in women. Due to its mechanism of action (type 2 5aR inhibition), finasteride use is contraindicated in women when they are or may be pregnant because of the risk of undervirilization of a developing male fetus. However, several studies have been published testing finasteride in women with a variety of disorders, including female pattern hair loss and hirsutism.

18.7.1 Study in postmenopausal women with androgenetic alopecia

To determine whether finasteride has utility in the treatment of women with AGA (female pattern hair loss), a randomized, placebo-controlled, one-year study of 137 postmenopausal women with AGA was conducted (Price etal. 2000). Women were eligible if they were assessed by the investigator as being Ludwig class I to II (Ludwig 1977) and Savin scale hair density and pattern classification 3 to 5 (Savin 1994). At the end of one year, no benefit of finasteride treatment compared to placebo was demonstrated in any predefined efficacy endpoint, including macrophotographic hair count, global photographic assessment, investigator assessment, patient self-assessment, and histopathologic analysis of scalp biopsies (Whiting et al. 1999). Thus, the pathophysiology of AGA in postmenopausal women appears to differ from that of men with AGA. This difference in response between men and post-menopausal women is likely related to the differing hormonal environment of the hair follicle between men and women and may explain the differing phenotypes of male and female pattern hair loss (Olsen 1994; Sawaya and Price 1997). Other lines of evidence supporting a differing pathophysiology between male and female pattern hair loss have been provided, including differences in the perifollicular hormonal environment and levels of 5aR activity in vitro. Taken together, these reports have prompted scientists to question whether typical female pattern hair loss is, in fact, androgen-dependent (Olsen 2001).

18.7.2 Studies in women with hirsutism

Several clinical trials evaluating the utility of finasteride in the treatment of women with hirsutism have been published (Castello etal. 1996; Ciotta etal. 1995; Erenus etal. 1997; Faloia etal. 1998; Falsetti etal. 1997; Fruzzetti etal. 1994; 1999; Moghetti etal. 1994; Sahin etal. 1998; Tolino etal. 1996; Venturoli etal. 1999; Wong etal. 1995). While some studies were uncontrolled and thus of limited value, others were conducted as placebo- or active comparator-controlled (with spironolactone, flutamide, ketoconazole or cyproterone acetate as comparator) trials. It should be noted that most of these studies enrolled premenopausal women of childbearing potential who were counseled regarding appropriate contraception requirements to avoid pregnancy; as was noted earlier, finasteride use is contraindicated in women when they are or maybe pregnant. Nonetheless, the results of some studies demonstrated that finasteride treatment produced modest benefit in women with hirsutism up to 12 months of observation, based on improvements in the Ferriman-Gallwey score (Ferriman and Gallwey 1961), terminal hair diameter, or other measures, that was superior to placebo and generally comparable to the active comparator used. Few side-effects related to finasteride treatment were reported in this patient population.



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