Clinical efficacy and safety of cyproterone acetate in severe hirsutism: results of a multicentered Canadian study.

We compared the efficacy and safety of cyproterone acetate (Shering AC, Berlin, FRG) at a low (Diane, 2 mg) or a high dose (Androcur, 100 mg) in the treatment of 158 patients with severe hirsutism. At baseline, no difference was observed in mean hirsutism total index (19.5 Diane versus 20.1 Androcur) or distribution (facial, bust, or abdomen). By the end of the study, patient loss in Diane and Androcur groups was 29.1% and 27.8%, respectively, and the mean percent difference in the scoring index was as follows: total, 24.6 Diane versus 30.8 Androcur, P less than 0.05; facial, 30.1 Diane versus 33.0 Androcur, P less than 0.10; bust, 12.1 Diane versus 31.2 Androcur, P less than 0.02; and abdomen, 20.1 Diane versus 31.2 Androcur, P less than 0.02. Except for breast tenderness (Diane greater than Androcur), amenorrhea, and weight gain, (Androcur greater than Diane), the incidence of side effects was comparable in both groups.