Medium-dose oral cyproterone acetate therapy in women with moderate androgenization. Results of a multicenter double-blind study

Abstract

The low-dose oral standard antiandrogen treatment with cyproterone acetate (CPA), Diane, is frequently associated with unsatisfactory results regarding moderate to severe seborrhoea/acne/acne and/or mild to moderate hirsutism. This multicenter double-blind study (n = 164) was, therefore, initiated to analyze the effectiveness of a medium dose oral regimen, i.e. the addition of 10 mg of CPA during the first 15 days of the Diane-treatment cycle. Good or satisfactory results after 3, 6, 9 and 12 months were observed in 61, 81, 95 and 97% of patients with moderate to severe seborrhoea (n = 79); in 53, 95, 98 and 100% of patients with moderate to severe acne (n = 62); and in 10, 28, 45 and 55% of patients with mild to moderate hirsutism (n = 89), respectively. The regression of moderate facial hirsutism and severe facial acne occurred faster and was more complete under the medium-dose than with the low-dose regimen. Side effects corresponded to those of conventional oral contraceptives except for a higher frequency of mastodynia. Both regimens caused a significant suppression of plasma dehydroepiandrosterone sulfate, while testosterone, triiodothyronine and thyroxine were lowered insignificantly. In contrast, cortisol, prolactin and insulin increased significantly. The extent of these changes did not differ in both modes of treatment. The medium-dose regimen (total dosage per cycle: 192 mg of CPA) is more effective than the low-dose regimen (42 mg of CPA per cycle) in the treatment of patients with moderate hyperandrogenism who do not require the high-dose oral standard antiandrogen therapy (1000 mg of CP A per cycle).