The contraceptive efficacy and tolerability of a new flexible extended regimen of EE 20 μg/DRSP 3 mg to extend the menstrual cycle enable intracyclic bleeding management investigated, and the bleeding pattern compared with a conventional 28-day regimen and a fixed extended 124-day regimen.
This Phase III, 2-year, multicentre, open-label study randomly allocated women to the following regimens: flexibleMIB; conventional, or fixed extended. Primary outcomes included bleeding/spotting days during Year 1 and the number of observed unintended pregnancies over two years.
The researchers analyzed the data of 1067 women. The mean number of spotting days was lower with the flexibleMIB vs. the conventional regimen. The corresponding value for the fixed extended regimen was 60.9±51.1 days. The Pearl Index for the flexibleMIB regimen was 0.64. All regimens had similar tolerability profiles.
The study concluded that EE 20 μg/DRSP 3 mg administered as a flexible extended regimen with MIB is effective, well-tolerated, and is associated with statistically significantly fewer bleeding/spotting days and withdrawal bleeding episodes vs. EE/DRSP in a conventional 28-day regimen.