Large observational trial of a new low-dose oral contraceptive containing 20 micrograms ethinylestradiol and 100 micrograms levonorgestrel (Miranova) in Germany.

The aim of this observational trial was to obtain clinical data from a large cohort of women using the new low-dose contraceptive (Miranova) and therefore to eliminate the restrictions which are normally present in clinical studies. Data were gathered in a clinical practice setting regarding cycle control and tolerance from women who were using Miranova (20 micrograms ethinylestradiol and 100 micrograms levonorgestrel). A total of 13,085 subjects were initially evaluated for this observational trial; data were available for 12,843 subjects during the treatment cycles. A total of 10,736 subjects (84.2%) completed all six treatment cycles. The method failure (Pearl index), calculated for 70,796 cycles, was 0.44. Cycle control was considered good during the trial; the length of cycle, duration of withdrawal bleeding and intensity of withdrawal bleeding did not significantly change during treatment. Intracyclic bleeding occurred mainly in the first cycle (31.4%) and declined significantly thereafter to a value of 14.5% in the third cycle. In the sixth (final) cycle, the intracyclic bleeding rate was 7.0%. There were no clinically relevant changes in mean systolic blood pressure, mean diastolic blood pressure or body weight. Miranova was shown to be an effective, well-tolerated oral contraceptive with good cycle control.