https://orcid.org/0000-0001-7325-4173
Abstract
Purpose
Dysmenorrhea negatively affects women’s quality of life and poses a considerable economic burden. A recent study in Japanese patients with dysmenorrhea (NCT01892904) reported a significant reduction in the number of days with menstrual pain after treatment with a flexible extended regimen of ethinylestradiol (EE)/drospirenone (DRSP) compared with a cyclic regimen. However, individual patients’ menstrual pain patterns and intensities were not indicated. Heatmapping was used to visualize menstrual pain patterns and intensities by re-evaluating the previously published data from NCT01892904.
Patients and Methods
NCT01892904 was a Phase III, multicenter, randomized, open-label, active-control study of 212 women aged ≥20 years randomized 1:1 to receive flexible extended or 28-day cyclic EE/DRSP treatment. Daily pain levels were recorded in patient diaries, and menstrual pain patterns and intensities were visualized using heatmapping. Patients were stratified by baseline dysmenorrhea scores and primary or secondary dysmenorrhea.
Results
The heatmap data demonstrated that EE/DRSP reduced the degree of menstrual pain. Regular peaks of menstrual pain were alleviated in the extended regimen group but were still observed in the cyclic regimen group. While a decrease in the days with menstrual pain was observed in patients with higher baseline dysmenorrhea scores (5–6), those with lower baseline scores (3–4) were more likely to experience lower intensities of menstrual pain. Although pain relief was less likely in patients with secondary dysmenorrhea, those who had lower baseline dysmenorrhea scores (3–4) and received the flexible extended regimen experienced a greater reduction in the number of days with menstrual pain than those who received the cyclic regimen.
Conclusion
Heatmapping effectively visualized the daily burden of menstrual pain in Japanese patients with dysmenorrhea. The analysis using heatmaps suggested that the flexible extended EE/DRSP treatment regimen was more likely to alleviate the regular occurrence of menstrual pain peaks compared with the cyclic regimen.
Abbreviations
EE/DRSP, ethinylestradiol/drospirenone; RR, rate ratio; MCF, mean cumulative function; QOL, quality of life; SD, standard deviation.
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. Interested researchers can use www.clinicalstudydatarequest.com to request access to available datasets and supporting documents from clinical studies to conduct further research that can help advance medical science or improve patient care. Information on the Bayer criteria for listing studies and other relevant information is provided in the “Study sponsors” section of the portal. Data access will be granted to available datasets, protocols, and clinical study reports after approval by an independent scientific review panel. Bayer is not involved in the decisions made by the independent review panel. Bayer will take all necessary measures to ensure that patient privacy is safeguarded.
Ethics Approval and Informed Consent
The protocol and all protocol amendments were reviewed and approved by each study site’s independent ethics committee/institutional review board (Suzuran Clinic, Ikebukuro Clinic, Seijo Kinoshita Hospital, Hayakawa Clinic, New Medical Research System Clinic, Shirokane Ladies’ Clinic, Juno Vesta Clinic Hatta, Chayamachi Ladies Clinic). All patients provided written informed consent before entering the study.
Acknowledgments
Medical writing services were provided by Marion Barnett and Sarah Bubeck, PhD, from Edanz Medical Writing, and sponsored by Bayer Yakuhin, Ltd. The authors would like to thank the patients who participated in the study and the staff members at the study sites who provided care for them. The authors also wish to thank Tetsushi Komori for providing guidance on the data analysis.
Author Contributions
MM, SA, and TF made contributions to the study conception and design; TF contributed to data analysis. All authors made substantial contributions to the interpretation of data and drafted or critically revised the article 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 is a paid medical advisor to Bayer Yakuhin, Ltd. for this study and outside of this study. Takeshi Fukai, Shigetomo Yamamoto, and Masami Kondo are employees of Bayer Yakuhin, Ltd. and Sayako Akiyama was an employee of Bayer Yakuhin, Ltd. during the conduct of this study. The authors report no other conflicts of interest related to this work.