Estetrol/drospirenone helps relieve dysmenorrhea

Treatment with estetrol/drospirenone (E4/DRSP) appears to be safe and efficacious in Japanese women with primary and secondary dysmenorrhea, according to a study.

A total of 162 Japanese women were randomly allocated to either the E4/DRSP or the placebo group. Women in the E4/DRSP group received one tablet containing E4 15 mg and DRSP 3 mg, administered orally daily for 24 days, followed by a placebo tablet for 4 days, constituting one cycle. Those in the placebo group received one placebo tablet daily for 28 days. After 16 weeks, women in the placebo group were switched to E4/DRSP for 36 weeks.

Researchers measured the absolute change in the most severe total dysmenorrhea score from baseline to the end of the 16-week double-blinded period as the primary outcome.

Results showed that E4/DRSP was associated with a 2.3-point reduction in the most severe total dysmenorrhea score from baseline to week 16. E4/DRSP was superior to placebo, with a between-group difference of −1.4 (95 percent confidence interval, −1.8 to −1.0).

The percentage of participants who achieved a ≥2.0-point reduction in the most severe total dysmenorrhea score from baseline was 64.3 percent in the E4/DRSP group vs 28.4 percent in the placebo group.

At week 16, visual analogue scale scores for pelvic pain and dysmenorrhea symptoms during the menstrual bleeding periods decreased by 44.2 and 42.3 mm, respectively, in the E4/DRSP group, significantly greater than that observed in the placebo group.

Objective gynaecological examinations in the E4/DRSP group indicated improvements in pelvic tenderness, uterine mobility, and cul-de sac induration. Furthermore, E4/DRSP was associated with better quality of life-related questionnaire (interference with daily activities and sleeping) and global impression scores.

The primary treatment-emergent adverse event in the E4/DRSP group was intermenstrual bleeding. None of the women who received E4/DRSP had venous thromboembolism.