An open-label randomized comparative study of oral contraceptives between medications containing 3 mg drospirenone/30 μg ethinylestradiol and 150 μg levonogestrel/30 μg ethinylestradiol in Thai women

Abstract

This study was conducted to compare the cycle control, efficacy and adverse events of a new low-dose oral contraceptive pill regimen containing 3 mg drospirenone (DRSP)/30 μg ethinylestradiol (EE), with a widely prescribed 150 μg levonogestrel (LNG)/30 μg EE. The results of this comparative trial demonstrated that the two preparations had no statistically significant difference in terms of cycle control, efficacy and adverse events. The occurrence of spotting and breakthrough bleeding was low and was not different between the two regimens. There was neither amenorrhea nor pregnancies reported in either group. The most common adverse events in both groups were nausea, headache and breast tenderness. Also statistically significant changes were found in body weight and blood pressure in both groups at the end of the study. In conclusion, the 3 mg DRSP/30 μg EE regimen provides good cycle control with reliable contraceptive efficacy and a low incidence of adverse events equal to the 150 μg LNG/30 μg EE preparation. Compared with the 150 μg LNG/30 μg EE preparation, the 3 mg DRSP/30 μg EE preparation demonstrated a more favorable effect on body weight and blood pressure, with the mean body weight and mean blood pressure remaining lower than baseline mean. The new formulation may be especially beneficial for women susceptible to body weight gain and rise in blood pressure.