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

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 microg ethinylestradiol (EE), with a widely prescribed 150 microg levonogestrel (LNG)/30 microg 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 microg EE regimen provides good cycle control with reliable contraceptive efficacy and a low incidence of adverse events equal to the 150 microg LNG/30 microg EE preparation. Compared with the 150 microg LNG/30 microg EE preparation, the 3 mg DRSP/30 microg 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.

RCT Entities:   Population Interventions Outcomes