NCT05445167已完成3 期
A Phase III Confirmatory Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration
研究概览
简要总结
Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal Japanese woman diagnosed with uterine fibroids
- •Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
- •Larger than a certain standard
- •No calcification
- •Not receiving surgical treatment
- •Patients with a normal menstrual cycle
- •Patients diagnosed with menorrhagia
- •Patients with pain symptoms associated with uterine fibroids
排除标准
- •Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
- •Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
- •Patients with undiagnosed abnormal genital bleeding
研究组 & 干预措施
KLH-2109
Experimental
干预措施: KLH-2109 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of women with a maximum NRS for pain score of 1 or less during 28 days before the end of study drug administration
时间窗: Up to 12 weeks
NRS (numeric rating scale) for pain
Proportion of subjects with a total PBAC score of less than 10 from Week 6 to 12 after beginning of study drug administration
时间窗: Up to 12 weeks
PBAC (pictorial blood loss assessment chart) score
次要结局
- Proportion of subjects with a total PBAC score of less than 10 from Week 2 to 6 after beginning of study drug administration(Up to 12 weeks)
- Average NRS score every 28 days for pain symptoms(Up to 12 weeks)
- Proportion of subjects with a maximum NRS score of 1 or less for pain symptoms every 28 days(Up to 12 weeks)
- Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) during 28 days before end of study drug administration(Up to 12 weeks)
- Proportion of subjects with a total PBAC score of less than 10 during 6 weeks before end of study drug administration(Up to 12 weeks)
- Percentage of asymptomatic days (number of the days with NRS score of zero for pain symptoms) every 28 days(Up to 12 weeks)
- Proportion of subjects with maximum NRS score of zero for pain symptoms during 28 days before end of study drug administration(Up to 12 weeks)
- Proportion of subjects with a maximum NRS score of zero for pain symptoms every 28 days(Up to 12 weeks)
- Incidence of adverse events and adverse drug reactions(Up to 12 weeks)
研究者
研究点 (1)
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