A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3 Study to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Proportion of subjects with a total PBAC score < 10
研究概览
简要总结
The goal of this clinical trial was to determine whether the investigational drug KLH-2109 is effective for treating excessive menstrual bleeding in patients with uterine fibroids. Uterine fibroids are benign tumors that grown in the uterus.
The primary objectives of this trial were to answer the following questions:
- Does KLH-2109 lower the amount of menstrual bleeding?
- Does KLH-2109 reduce menstrual bleeding?
- Is KLH-2109 safe for participants to use?
Investigators will compare KLH-2109 with a standard of care treatment (control) to determine which treatment is more effective.
Participants will be required to follow:
- Take either KLH-2109 or the common treatment as a pill
- Visit the clinic regularly for health checkups and safety tests
- Keep track of their bleeding and any health changes during the study
详细描述
A Multi-center, Randomized, Double-blind, Active-controlled, Parallel, Phase 3
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals diagnosed with uterine fibroids
排除标准
- •Metrorrhagia or anovulatory bleeding
- •Patients with a history of total hysterectomy or bilateral oophorectomy
研究组 & 干预措施
KLH-2109+ Leurprorelin acetate Placebo
KLH-2109: 200mg/day for 24 weeks(PO, QD) Leurprorelin acetate Placebo: Once every 4 weeks, subcutaneous injection
干预措施: KLH-2109+ Leurprorelin acetate Placebo (Drug)
KLH-2109 Placebo + Leurprorelin acetate
KLH-2109 Placebo: 24 weeks(PO, QD) Leurprorelin acetate : 1.88mg or 3.75mg, Once every 4 weeks, subcutaneous injection
干预措施: KLH-2109 Placebo + Leurprorelin acetate (Drug)
结局指标
主要结局
Proportion of subjects with a total PBAC score < 10
时间窗: Week 6 to the day before Week 12
Proportion of subjects with a total PBAC score \< 10 from Week 6 to the day before Week 12 after administration of the investigational product
次要结局
- Proportion of subjects with a total PBAC score < 10(Week 6 , Week12, Week 18, Week 24)