The efficacy and safety of dydrogesterone for treatment of dysmenorrhea: An open‐label multicenter clinical study

Abstract

Aims: Dydrogesterone is a retro-progesterone preparation widely used for over a half century. We sought to evaluate the efficacy and safety of dydrogesterone in Japanese women with dysmenorrhea. Methods: This study was conducted as an open-label, single-arm, multicenter study. One dydrogesterone 5-mg tablet (Duphaston) was administered orally twice daily for 21 days from the 5th to 25th day of each menstrual cycle. A total of 44 (safety analysis) and 31 patients (efficacy analysis) were enrolled. Total dysmenorrhea score, dysmenorrhea subscale scores, dysmenorrhea visual analog scale, severity of menstruation-related lower abdominal pain, low back pain, headache, and nausea/vomiting, basal body temperature, and serum estradiol and progesterone levels were evaluated. Results: Baseline of the total dysmenorrhea score was 4.61, which went down over time following the administration of dydrogesterone, and the decrease was statistically significant at and after 2nd cycle of menstruation. Mean change from baseline at the final evaluation point was −1.84 (P < 0.001). Severity of menstruation-related lower abdominal pain, low back pain, headache, and nausea/vomiting, in the evaluated menstruation cycles tended to decrease over time. Basal body temperature showed a biphasic pattern in 70% at baseline, 50% in 2nd menstruation cycle, and 61% in 5th menstruation cycle, and at least half of the patients may have had ovulation during the treatment. Incidence of adverse drug reactions was 31.8%, and the most common adverse event was metrorrhagia. Conclusion: Dydrogesterone is efficacious, safe, and clinically beneficial in patients with dysmenorrhea, thereby indicating that dydrogesterone can be considered as a treatment option for patients with dysmenorrhea.

An assessment of the efficacy and safety of dydrogesterone in women with ovarian endometrioma: An open‐label multicenter clinical study

“…29 In agreement with the present study, dydrogesterone was well tolerated although the trial reported a higher incidence of ADRs than this survey (31.8% versus 11.9%) and a higher incidence of the most common AE-abnormal uterine bleeding (29.5%; versus 5.1%). 29 These findings possibly reflect differences in the methodology for recording AEs, since in the Taniguchi study each patient recorded This real-world observational study has a number of limitations which need to be acknowledged. Firstly, it did not include a control group and so all conclusions about the relative effectiveness and safety of dydrogesterone must be guarded.…”

“…A recent open‐label trial of Japanese patients with dysmenorrhea reported that dydrogesterone significantly reduced total dysmenorrhea VAS scores and dysmenorrhea‐related pain symptoms 29 . In agreement with the present study, dydrogesterone was well tolerated although the trial reported a higher incidence of ADRs than this survey (31.8% versus 11.9%) and a higher incidence of the most common AE—abnormal uterine bleeding (29.5%; versus 5.1%) 29 .…”

“…A recent open‐label trial of Japanese patients with dysmenorrhea reported that dydrogesterone significantly reduced total dysmenorrhea VAS scores and dysmenorrhea‐related pain symptoms 29 . In agreement with the present study, dydrogesterone was well tolerated although the trial reported a higher incidence of ADRs than this survey (31.8% versus 11.9%) and a higher incidence of the most common AE—abnormal uterine bleeding (29.5%; versus 5.1%) 29 . These findings possibly reflect differences in the methodology for recording AEs, since in the Taniguchi study each patient recorded such events in a diary which is a more active method than used in the current study (survey and recorded on case report forms).…”

Hypertensive disorders of pregnancy are associated with dysmenorrhea in early adulthood: A cohort study

“…Among reproductive aged women, dysmenorrhea is one of the most common gynecologic problems. [5][6][7] Hypothesizing an association between dysmenorrhea, abnormal uterine contractility and failed placentation, we conducted a prospective cohort study and extracted the background lifestyle and gynecological characteristics for HDP (Table 1). Notably, we found that the history of dysmenorrhea in early adulthood increased the risk of developing HDP.…”

“…Dysmenorrhea is defined as pelvic or low‐back pain during the menstrual period in interference with activities of daily living. Among reproductive aged women, dysmenorrhea is one of the most common gynecologic problems 5–7 . Hypothesizing an association between dysmenorrhea, abnormal uterine contractility and failed placentation, we conducted a prospective cohort study and extracted the background lifestyle and gynecological characteristics for HDP (Table 1).…”