A Prospective Randomized Trial Comparing Low Dose Flutamide, Finasteride, Ketoconazole, and Cyproterone Acetate-Estrogen Regimens in the Treatment of Hirsutism

Abstract

Sixty-six hirsute women were randomized and treated with 1) flutamide (n = 15), 250 mg/day; 2) finasteride (n = 15), 5 mg/day; 3) ketoconazole (n = 16), 300 mg/day; and 4) ethinyl estradiol (EE)-cyproterone acetate (CPA; n = 20), 0.01 mg EE/day for the first week, 0.02 mg EE/day for the second week, and 0.01 mg EE/day for the third week, followed by a pause of 7 days, then 12.5 mg CPA/day added during the first 10 days of every month for 12 months. Hirsutism was evaluated by the Ferriman-Gallwey score, and hair diameter and hair growth rate were determined by a special image analysis processor in basal conditions and after 90, 180, 270, and 360 days of treatment. All treatments produced a significant decrease in the hirsutism score, hair diameter, and daily hair growth rate: flutamide, -55 +/- 13%, -21 +/- 14%, and -37 +/- 18%; finasteride, -44 +/- 13%, -16 +/- 12%, and -27 +/- 14%; ketoconazole, -53 +/- 18%, -14 +/- 12%, and -30 +/- 21%; and EE-CPA, -60 +/- 18%, -20 +/- 11%, and -28 +/- 21%. Some differences existed among treatments with regard to effectiveness; EE-CPA and flutamide seem to be the most efficacious in improving hirsutism. For the hirsutism score, a greater decrease was seen with EE-CPA (-60 +/- 18%) than with finasteride (-44 +/- 13%; P < 0.01) and a greater decrease was seen with flutamide (-58 +/- 18%) than with finasteride (-44 +/- 13%; P < 0.05). Flutamide is the fastest in decreasing hair diameter; EE-CPA is the fastest in slowing down hair growth, even though at the end of the treatment there was a significant difference between flutamide and finasteride only (-41 +/- 18% vs. -27 +/- 14%; P < 0.05). Flutamide, ketoconazole, and EE-CPA induced a significant decrease in total and free testosterone, 5alpha-dihydrotestosterone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, and androstenedione plasma levels. During the EE-CPA treatment, gonadotropins were suppressed, and the sex hormone-binding globulin level increased. Finasteride induced a decrease in dehydroepiandrosterone sulfate and 5alpha-dihydrotestosterone and an increase in testosterone levels. Very few side-effects were observed during treatment with low doses of flutamide, EE-CPA, and particularly finasteride. Flutamide induced a decrease whereas EE-CPA induced an increase in triglycerides and cholesterol, showing higher values within the normal range. Ketoconazole induced several side-effects and complications, and several people dropped out of the study. Despite different modalities of action and significantly different effects on androgen levels, low doses of flutamide, finasteride, and EE-CPA constitute very satisfactory alternative therapeutic regimens in the treatment of hirsutism.

Finasteride is effective for the treatment of central serous chorioretinopathy

“…49 Finasteride is approved by the FDA for the treatment of benign prostatic hyperplasia (BPH) and androgenic alopecia, and is known to have an excellent safety profile, [51][52][53] and has also been shown to have fewer side effects and drug interactions than ketoconazole. 54 Its most common adverse effect is decreased libido, and no laboratory workup is required except for monitoring of prostate-specific antigen in men with BPH who are using it long-term. In the only previous study of its use in CSC, finasteride was shown to improve CMT and SRF in five patients who were treated with it for 3 months and followed for 3 more, with no adverse events.…”

Comparison of high-dose finasteride (5 mg/day) versus low-dose finasteride (2.5 mg/day) in the treatment of hirsutism

“…Differences in clinical efficacy of antiandrogen drugs are minor and the choice of drug depends on the availability, cost and its side-effects (7). A low-dose antiandrogen may be a suitable choice in an attempt to prevent the incidence of side-effects and complications (22,23).…”

“…Previously, successful results had been obtained with finasteride in woman with hirsutism (9,25,26). Venturoli et al (22) reported that Ferriman -Gallwey scores in 15 women with hirsutism were significantly decreased (44%) after 12 months of finasteride therapy. Falsetti et al (11) observed that finasteride caused a significant reduction in the hirsutism scores in PCOS and idiopathic hirsutism at the end of 12 months.…”

“…The administration of finasteride is associated with a decrease in DHT and DHEAS levels and an increase in total testosterone levels (9,11,22,24). In our previous study (10), we have shown that serum E 2 and SHBG levels were increased and DHEAS levels were decreased significantly at 12 months.…”

Retrospective observational study on the effects and tolerability of flutamide in a large population of patients with various kinds of hirsutism over a 15-year period

“…Today, various satisfactory therapeutic regimens exist for the treatment of hirsutism (6). Among these, flutamide (Flu) is commonly defined as a pure selective anti-androgen with a non-steroidal structure and with no progestogenic, glucocorticoid, androgenic, oestrogenic or anti-gonadotrophic action (7).…”