A new association of ethinylestradiol (0.035 mg) cyproterone acetate (2 mg) in the therapy of polycystic ovary syndrome

Abstract

The authors treated 28 patients with polycystic ovary syndrome (PCOS) with the new preparation SH B 209 AE consisting of 0.035 mg of ethinylestradiol and 2 mg of cyproterone acetate (EE + CPA) throughout 12 months. From the analysis of the endocrine and clinical modifications induced by the drug along with the negligible incidence of side effects the conclusion can be drawn that this new estro-progestational association is indicated in the therapy of PCOS.

PIP: 28 patients with polycystic ovary syndrome were treated for 12 months with the new preparation SH B 209 AE, consisting of 0.035 mg of ethinyl estradiol and 2 mg of cyproterone acetate. This was the first clinical trial of estroprogestational therapy on a homogeneous sample of women with polycystic ovary syndrome. Endocrine findings indicated a significant decrease in all hormonal parameters, the invariableness of prolactinemia, a considerable increase in sex hormone binding globulin (SHBG) at the 6th treatment cycle examination, a continuous significant decrease in 17 beta E2 and androstenedione from the 6th to the 12th treatment cycles. In terms of clinical findings, there was a significant decline in the severity of acne, seborrhea, and hirsutism during drug administration. The menstrual cycle in the 28 study subjects remained under control during treatment, and there were no pregnancies. Side effects such as weight gain, nausea, headache, and changes in libido were not reported. Overall, the findings of this study suggest that administration of the new monophasic contraceptive association SH B 209 AE can normalize endocrine patterns in polycystic ovary syndrome and improve its androgenic symptomatology. The low content of estrogen, the changes in clinical and hormonal parameters, the low incidence of side effects, and the good control of the menstrual cycle provided by this treatment make SH B 209 AE deserving of more widespread application.