A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of BG2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 29
- 主要终点
- Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24.
研究概览
简要总结
The primary objective of this study is to demonstrate the superior efficacy versus placebo of BG2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
详细描述
The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of BG2109 alone and in combination with add-back therapy (Estradiol 1 mg / Norethindrone Acetate 0.5 mg) for the treatment of uterine fibroids in China.
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
- •Subject is an 18 years and older premenopausal woman.
- •Subject's Body Mass Index ≥ 18 kg/m
- •Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound.
- •Subject's menstrual cycles is between 21 days and 35 days in the last 3 months.
- •Subject has clinical manifestations of heavy menstrual bleeding.
- •Subject's menstrual blood loss >80mL for at least 2 menstrual periods assessed at screening using the alkaline hematin method.
排除标准
- •The subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study.
- •The subject has a history of uterus surgery that would interfere with the study.
- •The subject's condition is so severe that she will require surgery within 6 months.
- •The subject have had or are currently suffering from any estrogen- dependent malignancy.
- •The subject has a significant risk of osteoporosis, or have a known history of osteoporosis or other metabolic bone disease.
研究组 & 干预措施
BG2109 200mg+ABT group
Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.
干预措施: Add-back therapy (Drug)
BG2109 100mg group
One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
干预措施: BG2109 (Drug)
BG2109 100mg group
One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
干预措施: Placebo for BG2109 (Drug)
BG2109 100mg group
One tablet of BG2109 100mg + one tablet of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
干预措施: Placebo for add-back therapy (Drug)
BG2109 200mg+ABT group
Two tablets of BG2109 100mg + one tablet of add-back therapy, oral, once-daily.
干预措施: BG2109 (Drug)
Placebo group
Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
干预措施: Placebo for BG2109 (Drug)
Placebo group
Two tablets of placebo for BG2109 + one tablet of placebo for add-back therapy, oral, once-daily.
干预措施: Placebo for add-back therapy (Drug)
结局指标
主要结局
Percentage of Responders based on menstrual blood loss (MBL) volume reduction at Week 24.
时间窗: The last 28 days before the Week 24.
MBL will be determined using the Alkaline Hematin method (AHM). Responder means whose MBL less than 80mL during the last 28 days before the Week 24 and more than 50% reduction in MBL compared to the baseline.
次要结局
- Time to reduced MBL before the Week 24.(From baseline to Week 24.)
- Percentage of amenorrhea at the Week 24.(From baseline to Week 24.)
- Time to amenorrhea before the Week 24.(From baseline to Week 24.)
- Days of menstrual bleeding in the last 28 days before the Week 24.(The last 28 days before the Week 24.)
- Hemoglobin levels at the Week 24 in the subgroup of subjects with anemia.(The Week 24.)