The development and evaluation of an ovulation inhibitor (DIAne) containing an antiandrogen

Abstract

The combination of 2 mg cyproterone acetate, a pronounced antiandrogenic substance, in combination with 0.05 mg ethinyl estradiol has undergone intensive multiphasic clinical evaluation. The preparation with the trade name Diane has proven to be not only a reliable contraceptive, but also a very potent drug for the treatment of both acne and seborrhea, and of milder cases of hirsutism. The effect of Diane on markedly increased hair growth was not so pronounced. In addition to the presentation of the most pertinent steps of the clinical investigation of Diane, the possible mode of actions of antiandrogens alone and in combination with an estrogen is discussed.