Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tokyo, Tokyo, Japan.
Clinical Development Department, Mochida Pharmaceutical Co., Ltd., Tokyo, Japan.
Fertil Steril. 2020 Mar;113(3):627-635.e1. doi: 10.1016/j.fertnstert.2019.11.010.
To evaluate the efficacy and safety of dienogest (DNG), a progestational 19-norsteroid, in patients with primary and secondary dysmenorrhea.
Phase III, randomized, double-blind, multicenter, placebo-controlled study.
Clinical study sites in Japan.
PATIENT(S): Ninety-four women with dysmenorrhea.
INTERVENTION(S): Random assignment to receive DNG (1 mg/day, orally) or placebo for 12 weeks; patients treated for anemia before randomization in cases of complicated anemia.
MAIN OUTCOME MEASURE(S): Change in the dysmenorrhea score from baseline to week 12 of treatment with visual analog scale used for pain assessment.
RESULT(S): The DNG group was superior to the placebo group in terms of the change from baseline in the dysmenorrhea score at week 12 of treatment in patients with dysmenorrhea. In both primary and secondary dysmenorrhea, the DNG group was superior to the placebo group for each diagnostic category. The mean serum estradiol concentrations were similar between the DNG and the placebo groups. Although the incidence of irregular uterine bleeding was higher in the DNG group, there were no severe or serious events. Most events of genital bleeding were spotting or breakthrough bleeding, suggesting DNG was well tolerated.
CONCLUSION(S): In both primary and secondary dysmenorrhea, DNG at 1 mg/day relieved pain and was well tolerated.
JapicCTI-173547(en).
评估地诺孕素（DNG）作为一种孕激素 19-去甲甾体在原发性和继发性痛经患者中的疗效和安全性。
III 期、随机、双盲、多中心、安慰剂对照研究。
日本临床研究场所。
94 名痛经患者。
随机接受 DNG（1 毫克/天，口服）或安慰剂治疗 12 周；在随机分组前治疗复杂贫血的患者给予贫血治疗。
使用视觉模拟评分法评估疼痛的痛经评分从基线到治疗第 12 周的变化。
DNG 组在原发性和继发性痛经患者中，与安慰剂组相比，治疗第 12 周时痛经评分的变化具有统计学意义。在原发性和继发性痛经的每个诊断类别中，DNG 组均优于安慰剂组。DNG 组和安慰剂组的血清雌二醇浓度相似。虽然 DNG 组不规则子宫出血的发生率较高，但无严重或严重不良事件。大多数生殖道出血事件为点滴出血或突破性出血，表明 DNG 具有良好的耐受性。
DNG 每天 1 毫克可缓解原发性和继发性痛经的疼痛，且耐受性良好。
JapicCTI-173547(en)。
