Efficacy and safety of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg combination in a cyclic regimen for the treatment of primary and secondary dysmenorrhea: A multicenter, placebo-controlled, double-blind, randomized study

To evaluate the efficacy and safety of the estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg combination in a cyclic regimen in Japanese women with primary and secondary dysmenorrhea.OBJECTIVETo evaluate the efficacy and safety of the estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg combination in a cyclic regimen in Japanese women with primary and secondary dysmenorrhea.A 16-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study, followed by a 36-week, open-label, extension study.DESIGNA 16-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study, followed by a 36-week, open-label, extension study.162 Japanese women with primary and secondary dysmenorrhea.SUBJECTS162 Japanese women with primary and secondary dysmenorrhea.Participants were randomly allocated to either the E4/DRSP group or the placebo group. In the E4/DRSP group, participants orally received one tablet containing E4 15 mg and DRSP 3 mg daily for 24 days, followed by a placebo tablet for 4 days, constituting one cycle. The placebo group was given one placebo tablet daily for 28 days. After 16 weeks, participants in the placebo group were switched to receive E4/DRSP for 36 weeks.INTERVENTIONParticipants were randomly allocated to either the E4/DRSP group or the placebo group. In the E4/DRSP group, participants orally received one tablet containing E4 15 mg and DRSP 3 mg daily for 24 days, followed by a placebo tablet for 4 days, constituting one cycle. The placebo group was given one placebo tablet daily for 28 days. After 16 weeks, participants in the placebo group were switched to receive E4/DRSP for 36 weeks.Absolute change in the most severe total dysmenorrhea score from baseline to the end of the 16-week double-blinded period.MAIN OUTCOME MEASURESAbsolute change in the most severe total dysmenorrhea score from baseline to the end of the 16-week double-blinded period.E4/DRSP reduced the most severe total dysmenorrhea score by 2.3 points from baseline at week 16. The between-group difference was significant (-1.4, two-sided 95% confidence interval: -1.8 to -1.0), showing superiority to placebo (p