Back to Journals » International Journal of Women's Health » Volume 12

Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 μg/Drospirenone 3 mg in a Real-World Setting: An Observational Study

Authors Momoeda M, Akiyama S, Tanaka K, Suzukamo Y

Received 13 November 2019

Accepted for publication 26 March 2020

Published 4 May 2020 Volume 2020:12 Pages 327—338


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Everett F. Magann

Mikio Momoeda,1 Sayako Akiyama,2 Kota Tanaka,3 Yoshimi Suzukamo4

1Department of Integrated Women’s Health, St. Luke’s International Hospital, Tokyo, Japan; 2Market Access, Bayer Yakuhin, Ltd., Tokyo, Japan; 3Statistics Analysis Department 2, EPS Corporation, Osaka, Japan; 4Department of Physical Medicine and Rehabilitation, Tohoku University, Sendai, Japan

Correspondence: Mikio Momoeda
Department of Integrated Women’s Health, St. Luke’s International Hospital, 9-1 Akashicho, Chuo City, Tokyo 104-8560, Japan
Tel +81-3-3541-5151
Fax +81-3-5550-2605

Background: Dysmenorrhea affects approximately 80% of women in Japan and has a negative impact on health-related quality of life (HRQoL). Low-dose estrogen/progestin combined oral contraceptives have been shown to reduce the severity of dysmenorrhea symptoms. This study characterized HRQoL in Japanese women with dysmenorrhea before and after ethinylestradiol/drospirenone (EE/DRSP) treatment.
Methods: This prospective, observational study recruited 531 patients, of which 186 were evaluated after treatment with EE 20 μg/DRSP 3 mg for dysmenorrhea in a 24/4 cyclic regimen. The primary endpoints were mean baseline and post-treatment 36-Item Short-Form Health Survey version 2.0 (SF-36v2) scores for study patients compared with the general female population of Japan (calculated using norm-based scoring), and mean changes in study patient SF-36v2 scores between baseline and 6 to 8 treatment cycles.
Results: Compared with Japanese norms, women with dysmenorrhea had lower pre-treatment SF-36v2 scores, except for the physical functioning domain. After 6– 8 cycles of EE/DRSP treatment, all 8 SF-36v2 domain scores were significantly higher than baseline. The greatest improvements were observed in bodily pain and social functioning (mean change [standard deviation (SD)]: physical functioning: 1.4 [5.7], role physical: 3.2 [8.1], bodily pain: 7.8 [10.0], general health: 3.0 [7.0], vitality: 2.7 [8.1], social functioning: 3.5 [9.8], role emotional: 3.3 [9.2], and mental health: 3.0 [7.3]; p< 0.001 for all). Compared with the Japanese general population, study patients’ post-treatment scores were significantly higher for the general health domain (p= 0.008) and physical summary scores (p= 0.033).
Conclusion: Dysmenorrhea has a profound impact on all aspects of functioning and well-being. This study, conducted in a real-world setting, found that physical, social, and mental HRQoL improved significantly after a cyclic regimen of EE/DRSP in Japanese patients with dysmenorrhea. This regimen may have the potential to provide an effective option to improve patient HRQoL.
Trial Registration: Study sample was drawn from patients enrolled in a post-marketing surveillance study, registered June 20, 2011 (NCT 01375998).

Keywords: patient-reported outcomes, SF-36, dysmenorrhea, quality of life, ethinylestradiol/drospirenone, Japan

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]