RESUMEN
The efficacy and safety of the low dose monophasic oral contraceptive (OC) combination containing 30 micrograms of ethinylestradiol (EE) and 2.0 mg of dienogest (DNG) (EE/DNG) was evaluated in a prospective, open-label, multicenter, uncontrolled, phase III trial. The trial was carried out in five hospitals in Poland, and included 431 healthy women (aged 18-35 years), over 12 cycles, with a total of 4608 cycles. EE/DNG provided reliable ovulation inhibition. No women became pregnant during the trial. The unadjusted Pearl index was 0. EE/DNG provided good cycle control and reduced the incidence of intermenstrual bleedings, the intensity of menstrual bleeding and frequency of dysmenorrhea. Due to the antiandrogenic properties of the progestogen component DNG, EE/DNG improved androgen-related conditions, such as skin blemishes, hair greasiness and acne vulgaris. Of 50 women with acne, 80% improved after the 6th cycle and 1 was healed. After 12 cycles, 54% were improved and 37% were healed. Breast tenderness and gastric complaints were the most frequent of the common complaints due to treatment with EE/DNG. The frequency of all complaints decreased steadily over time. Only 5.6% of subjects discontinued due to adverse reactions. No thrombophlebitic events were noticed.