https://orcid.org/0000-0001-7325-4173
Abstract
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).
Abbreviations
ANCOVA, analyses of covariance; CI, confidence interval; HRQoL, health-related quality of life; JAOG, Japan Association of Obstetricians and Gynecologists; JSOG, Japan Society of Obstetrics and Gynecology; LEP, low-dose estrogen/progestin; LSM, least squares mean; MCID, minimal clinically important differences; PMS, post-marketing surveillance; QOL, quality of life; SD, standard deviation; SF-36, 36-Item Short-Form Health Survey.
Data Sharing Statement
Availability of the data underlying this publication will be determined according to Bayer’s commitment to the EFPIA/PhRMA “Principles for responsible clinical trial data sharing.” This pertains to scope, time point, and process of data access. As such, Bayer commits to sharing, upon request from qualified scientific and medical researchers, patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and European Union (EU) as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 1, 2014.
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Ethics and Consent Statement
Japan’s Ministry of Health, Labour, and Welfare requires post-marketing surveillance for all drugs, and the current study was conducted as part of a regulatory mandate. All study data were collected during actual clinical practice; patients provided prior, written informed consent for their data to be used in research, but no national ethical approvals were required to conduct this study.
Acknowledgments
The authors are thankful to all the study-clinic health-care professionals for their participation in this study. The authors would like to thank Caitlin Rothermel (McCANN HEALTH CMC) for medical writing assistance. The authors also wish to thank the Bayer PMS team for their contributions to the study operation.
Author contributions
All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.
Disclosure
Mikio Momoeda was a paid medical advisor to Bayer Yakuhin, Ltd. for the duration of the study. Sayako Akiyama was an employee of Bayer Yakuhin, Ltd. at that time of the study. Kota Tanaka is an employee of EPS, which received funding from Bayer for the statistical analysis and reporting of study data. Yoshimi Suzukamo was a paid advisor on patient-reported outcome research to Bayer Yakuhin, Ltd. for the duration of the study. The authors report no other conflicts of interest in this work.