ArticleInternational journal of women's health2017
Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study.
Article in International journal of women's health, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 3 of them syntheses that pooled it.
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Who cites it
11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.
- Combined oral contraceptive pill for primary dysmenorrhoea.The Cochrane database of systematic reviews · 2023Pooled it
- Efficacy of Low-Dose Estrogen-Progestins and Progestins in Japanese Women with Dysmenorrhea: A Systematic Review and Network Meta-analysis.Advances in therapy · 2022Pooled it
- Effect and safety of drospirenone and ethinylestradiol tablets (II) for dysmenorrhea: A systematic review and meta-analysis.Frontiers in medicine · 2022Pooled it
- Efficacy and safety of desogestrel/ethinylestradiol 150/20 flexible extended regimen (FREEDOM 150/20) in dysmenorrhea: phase 3 study in Japan.F&S reports · 2026Article
- Real-world treatment patterns in patients with dysmenorrhea in Japan: a retrospective database study.Frontiers in global women's health · 2026Article
- Multicentre Trial Evaluating the Safety and Tolerability of Estetrol-Drospirenone Combined Oral Contraceptive in Postmenarchal Female Adolescents.Journal of clinical medicine · 2025Article
- 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
- Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study.International journal of women's health · 2020Article
- Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 μg/Drospirenone 3 mg in a Real-World Setting: An Observational Study.International journal of women's health · 2020Article
- Continuous vs. cyclic combined hormonal contraceptives for treatment of dysmenorrhea: a systematic review.Contraception: X · 2019Article
- A comparison of combined oral contraceptives containing chlormadinone acetate versus drospirenone for the treatment of acne and dysmenorrhea: a randomized trial.Contraception and reproductive medicine · 2018Article
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Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDysmenorrhea is a common condition in women, which is characterized by menstrual pain. Low-dose estrogen/progestin combined oral contraceptives have been shown to reduce the severity of dysmenorrhea symptoms, and a 28-day cyclic regimen of ethinylestradiol/drospirenone (28d regimen) is approved for this indication in Japan.
aimThe aim of this study was to assess the safety and efficacy of a flexible extended regimen of ethinylestradiol/drospirenone (flexible regimen) in Japanese women with dysmenorrhea.
methodsThis multicenter, open-label study was performed in Japanese women with dysmenorrhea who, after a baseline observational phase, were randomized to receive ethinylestradiol 20 μg/drospirenone 3 mg in a flexible regimen (one tablet each day for 24-120 days followed by a 4-day tablet-free interval) or in the standard 28d regimen (one tablet each day for 24 days, followed by 4 days of placebo tablets for six cycles). The primary endpoint was the number of days with dysmenorrhea of at least mild intensity over a 140-day evaluation period. Dysmenorrhea scores, bleeding patterns, and other pain-related parameters were also assessed.
resultsA total of 216 women (mean age 29.7 years) were randomized to the flexible regimen (n=108) or 28d regimen (n=108) and 212 were included in the full analysis sets (flexible regimen, n=105; 28d regimen, n=107). Women in the flexible-regimen group reported a mean of 3.4 fewer days with dysmenorrheic pain than women in the 28d-regimen group, with similar decreases in disease severity reported in both treatment groups. According to the investigators, 64.8% and 59.4% of women in the flexible-regimen and 28d-regimen treatment groups had "very much improved" or "much improved" disease, while 54.3% and 50.9% of patients reported being "very much satisfied" or "much satisfied" with their treatment, respectively.
conclusionIn Japanese women with dysmenorrhea, a flexible extended regimen of ethinylestradiol/drospirenone decreased the number of days with dysmenorrheic pain versus the traditional 28d regimen.
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