Department of Obstetrics and Gynecology, Tottori University School of Medicine, Tottori, Japan.
Department of Integrated Women's Health, St. Luke's International Hospital, Tokyo, Japan.
Fertil Steril. 2016 Dec;106(7):1807-1814. doi: 10.1016/j.fertnstert.2016.08.051. Epub 2016 Oct 4.
To evaluate the efficacy and safety of an ultra-low-dose oral contraceptive (NPC-01; 0.02 mg ethinyl estradiol and 1 mg norethisterone) in subjects with dysmenorrhea.
Placebo-controlled, double-blind, randomized trial.
Clinical trial sites.
PATIENT(S): Two hundred fifteen subjects with dysmenorrhea.
INTERVENTION(S): Subjects were randomly assigned to receive NPC-01, placebo, or IKH-01 (0.035 mg ethinyl estradiol and 1 mg norethisterone) for four cycles.
MAIN OUTCOME MEASURE(S): Total dysmenorrhea score (verbal rating scale) assessing pain on the basis of limited ability to work and need for analgesics.
RESULT(S): The reductions of total dysmenorrhea score and visual analog scale score after the treatment were significantly higher in the NPC-01 group than in the placebo group. Furthermore, the efficacy of NPC-01 was comparable to that of IKH-01. The overall incidence of side effects was significantly higher in the NPC-01 group than in the placebo group. All side effects that occurred in the NPC-01 group were previously reported in patients receiving IKH-01. No serious side effects occurred.
CONCLUSION(S): The ultra-low-dose contraceptive NPC-01 relieved dysmenorrhea as effectively as IKH-01. Thus, NPC-01 could represent a new option for long-term treatment of dysmenorrhea.
NCT01129102.
评估一种超低剂量口服避孕药（NPC-01；0.02 毫克炔雌醇和 1 毫克去氧孕烯）在痛经患者中的疗效和安全性。
安慰剂对照、双盲、随机试验。
临床试验地点。
215 例痛经患者。
受试者随机接受 NPC-01、安慰剂或 IKH-01（0.035 毫克炔雌醇和 1 毫克去氧孕烯）治疗四个周期。
总痛经评分（基于工作能力受限和需要镇痛药的言语评定量表）评估疼痛。
治疗后 NPC-01 组总痛经评分和视觉模拟评分的降低明显高于安慰剂组。此外，NPC-01 的疗效与 IKH-01 相当。NPC-01 组不良反应总发生率明显高于安慰剂组。NPC-01 组发生的所有不良反应均为既往接受 IKH-01 治疗的患者所报告。未发生严重不良反应。
超低剂量避孕药 NPC-01 缓解痛经的效果与 IKH-01 一样有效。因此，NPC-01 可能成为长期治疗痛经的一种新选择。
NCT01129102。
