Effectiveness of ethinylestradiol/drospirenone for premenstrual symptoms in Japanese patients with dysmenorrhea: Open-label pilot study

Aim A combined oral contraceptive containing ethinylestradiol 20μg plus drospirenone 3mg (EE20+DRSP) in a 24/4 regimen has been shown to alleviate the symptoms of premenstrual syndrome and premenstrual dysphoric disorder. This study was conducted to evaluate the efficacy of EE20+DRSP in Japanese patients with premenstrual symptoms. Material and Methods A multicenter, prospective, open-label, single-arm, phase IV study was performed in Japanese women with dysmenorrhea and premenstrual symptoms. They were treated with EE20+DRSP to alleviate the symptoms of dysmenorrhea for six treatment cycles. Premenstrual symptoms were evaluated using a Premenstrual Symptoms Questionnaire at baseline and after three and six cycles of EE20+DRSP. The degree of dysmenorrhea was also evaluated using a visual analog scale at baseline and after one, three, and six cycles of EE20+DRSP. Results Forty-eight patients were treated with EE20+DRSP. Most of the premenstrual symptoms were alleviated significantly by three and six cycles of EE20+DRSP treatment. EE20+DRSP treatment significantly improved the severity of premenstrual symptoms. We also confirmed the effectiveness of EE20+DRSP for the treatment for dysmenorrhea. Conclusion This study showed that EE20+DRSP could be a useful treatment strategy for premenstrual symptoms in Japanese women.