NCT07015268进行中（未招募）3 期
Phase III Confirmatory Study of KLH-2109 in Patients With Endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment
研究概览
简要总结
To verify the non-inferiority of KLH-2109 to leuprorelin acetate in a double-blind manner in terms of efficacy in endometriosis patients with pelvic 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women aged 18 years or older (at the time of consent) with endometriosis who meet any of the following inclusion criteria.:
- •A diagnosis of endometriosis by laparotomy or laparoscopy within 5 years before the start of the screening period;
- •Ovarian chocolate cyst confirmed by MRI performed within 1 year before the start of the screening period or ultrasonography (transvaginal, transabdominal, or transrectal) carried out at the start of the screening period; or
- •Any of induration of the pouch of Douglas, limitation of uterine mobility, and pelvic tenderness based on the result of pelvic/rectal examination at the start of the screening period and a diagnosis of clinical endometriosis
排除标准
- •Patients with undiagnosed abnormal genital bleeding
- •Patients with abnormal uterine bleeding or anovulatory bleeding judged to be severe by the principal investigator or subinvestigator
- •Patients with concomitant chronic abdominal pain not attributable to endometriosis (such as irritable bowel syndrome [IBS] and interstitial cystitis)
- •Patients with concomitant pelvic inflammatory disease or a history of pelvic inflammatory disease within 8 weeks before obtaining informed consent
研究组 & 干预措施
KLH-2109 group
Experimental
Oral administration
干预措施: KLH-2109 (Drug)
Leuprorelin group
Active Comparator
Subcutaneous administration
干预措施: Leuprorelin acetate (Drug)
结局指标
主要结局
Change from baseline in the maximum NRS score for pelvic pain during 28 days prior to 12 weeks of the investigational product treatment
时间窗: 12 weeks
NRS score for pelvic pain: The NRS score for pelvic pain is an integer scale of 0 to 10 in which the worst daily pain associated with endometriosis is scored as 0 for "no pain" and 10 for "the worst pain imaginable."
次要结局
- Change from baseline in and actual values of the maximum NRS score for pelvic pain every 28 days(Up to 24 weeks)
- Change from baseline in and actual values of the maximum severity score for pelvic pain every 28 days(Up to 24 weeks)
- Percent change from baseline in bone mineral density at each evaluation time point(Up to 24 weeks)
- Change from baseline in and actual values of severity score for temporary pain at each evaluation time point(Up to 24 weeks)
- Change from baseline in and actual values of severity score of objective findings at each evaluation time point(Up to 24 weeks)
- Percent change from baseline in and actual values of ovarian chocolate cyst volume at each evaluation time point(Up to 24 weeks)
- Change from baseline in and actual values of EHP-30 domain score at each evaluation time point(Up to 24 weeks)
- Incidence of adverse events and treatment-related adverse events(Up to 24 weeks)
- Change from baseline in T-score at each evaluation time point(Up to 24 weeks)
研究者
研究点 (1)
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