ArticleInternational journal of women's health2020
Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study.
Article in International journal of women's health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01892904 (A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group Comparative Study to Assess Efficacy and Safety of a Flexible Extended Regimen of BAY 86-5300 (0.02 mg Ethinylestradiol [β-CDC] and 3 mg Drospirenone) Compared to the 28-day (24 + 4-day) Regimen of BAY 86-5300 in the Treatment of Dysmenorrhea for 24 Weeks
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Effect and safety of drospirenone and ethinylestradiol tablets (II) for dysmenorrhea: A systematic review and meta-analysis.Frontiers in medicine · 2022Pooled it
- Beverage consumption patterns and primary dysmenorrhea among women of reproductive age: a population-based study in Beijing, China.Frontiers in nutrition · 2026Article
- Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study.Advances in therapy · 2022Observational
- Comparison of the Effects of Hysteroscopic Cold Broad Sword Play Combined with Estrogen and Progestin Sequential Therapy and Drospirenone and Ethinylestradiol Tablets in Patients with Severe Intrauterine Adhesion.Emergency medicine international · 2022Article
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeDysmenorrhea 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
methodsNCT01892904 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.
resultsThe 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.
conclusionHeatmapping 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.
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