Efficacy of cyclic and extended regimens of ethinylestradiol 0.02 mg ‐levonorgestrel 0.09 mg for dysmenorrhea: A placebo‐controlled, double‐blind, randomized trial

• Main Authors: Tasuku Harada, Mikio Momoeda
• Format: Article
• Language: English
• Published: Wiley 2021-04-01
• Series: Reproductive Medicine and Biology
• Subjects: dysmenorrhea; ethinylestradiol; levonorgestrel; low‐dose estrogen/progestin combination product; placebo‐controlled randomized trial
• Online Access: https://doi.org/10.1002/rmb2.12373

Abstract Purpose We aimed to evaluate the efficacy and safety of 28‐day Cyclic and 84‐day Extended regimens of NPC‐16 (ethinylestradiol 0.02 mg plus levonorgestrel 0.09 mg) in patients with dysmenorrhea. Methods This was a placebo‐controlled, double‐blind, randomized trial conducted in Japan. A total of 251 primary and secondary dysmenorrhea patients were randomly assigned to the NPC‐16‐Cyclic group, NPC‐16‐Extended group, or the Placebo group. The primary end point was a comparison of the efficacy and safety of the Cyclic and Extended NPC‐16 regimen for the treatment of dysmenorrhea relative to the Placebo. Main findings Significantly greater reductions in total dysmenorrhea score and visual analog scale score were observed in the Cyclic and Extended groups compared with the Placebo group. Compared with the Cyclic regimen as a secondary end point, the Extended regimen exhibited greater efficacy in the treatment of dysmenorrhea over the course of the study period, particularly in patients with severe dysmenorrhea. The incidence of adverse drug reactions (ADRs) was significantly higher in the Cyclic and Extended groups than in the Placebo group. Conclusion The Cyclic and Extended regimens of NPC‐16 significantly reduced dysmenorrhea severity compared to placebo. The Extended regimen was superior to cyclic regimen in reducing the dysmenorrhea.