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. 2021 Feb 27;20(2):215-223.
doi: 10.1002/rmb2.12373. eCollection 2021 Apr.

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

Tasuku Harada  1 , Mikio Momoeda  2
Affiliations

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

Tasuku Harada et al. Reprod Med Biol. .

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.

Keywords: dysmenorrhea; ethinylestradiol; levonorgestrel; low‐dose estrogen/progestin combination product; placebo‐controlled randomized trial.

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Conflict of interest statement

Conflicts of interest: Tasuku Harada and Mikio Momoeda received consulting fees from Nobelpharma Co., Ltd.

Figures

FIGURE 1
FIGURE 1
Flow‐chart of patients and study design. N, NPC‐16; P, Placebo
FIGURE 2
FIGURE 2
Change in total dysmenorrhea and visual analog scale scores. Change in total dysmenorrhea score (A) and visual analog scale score (B) among all patients, and change in total dysmenorrhea score in patients with a baseline total dysmenorrhea score of 3 or 4 (C) or those with a baseline total dysmenorrhea score of 5 or 6 (D) for the Cyclic versus. Extended regimens. VAS, visual analog scale
FIGURE 3
FIGURE 3
Change in dysmenorrhea score from baseline in the Cyclic and Extended groups. Least‐squares means were calculated using a mixed model for repeated measures for change in the dysmenorrhea score from baseline to the mean of 3 cycles. * P < .001 by two‐sample t‐test for NPC‐16‐Cyclic versus NPC‐16‐ Extended adjusted using Bonferroni's method
See this image and copyright information in PMC

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