A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 571
- 主要终点
- Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
研究概览
简要总结
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
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 51 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is pre-menopausal female 18 to 51 years of age at Screening.
- •Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
- •Subject has heavy uterine bleeding associated with uterine fibroids.
排除标准
- •Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
- •Subject has a history of osteoporosis or other metabolic bone disease.
- •Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
- •Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
研究组 & 干预措施
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID alone
干预措施: Elagolix (Drug)
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID alone
干预措施: E2/NETA placebo (Drug)
Cohort 1: Placebo
Placebo for elagolix and placebo for E2/NETA twice daily (BID)
干预措施: Elagolix placebo (Other)
Cohort 1: Placebo
Placebo for elagolix and placebo for E2/NETA twice daily (BID)
干预措施: E2/NETA placebo (Drug)
Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD
Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)
干预措施: Elagolix (Drug)
Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD
Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)
干预措施: 0.5 mg estradiol / 0.1 mg norethindrone acetate (Drug)
Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD
Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
干预措施: Elagolix (Drug)
Cohort 1: Elagolix 300 mg BID plus SD E2/NETA QD
Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
干预措施: 1 mg estradiol / 0.5 mg norethindrone acetate (Drug)
Cohort 2: Placebo
Placebo for elagolix and E2/NETA QD
干预措施: Elagolix placebo (Other)
Cohort 2: Placebo
Placebo for elagolix and E2/NETA QD
干预措施: E2/NETA placebo (Drug)
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD alone
干预措施: Elagolix (Drug)
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD alone
干预措施: E2/NETA placebo (Drug)
Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
干预措施: Elagolix (Drug)
Cohort 2: Elagolix 600 mg QD plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
干预措施: 0.5 mg estradiol / 0.1 mg norethindrone acetate (Drug)
Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
干预措施: Elagolix (Drug)
Cohort 2: Elagolix 600 mg QD plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
干预措施: 1 mg estradiol / 0.5 mg norethindrone acetate (Drug)
结局指标
主要结局
Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
时间窗: Baseline, Final Month (last 28 days of treatment)
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of \< 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
次要结局
- Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit(Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination))
- Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit(Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination))
- Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month(Final Month (last 28 days of treatment))
- Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit(Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination))
- Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit(Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination))
- Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit(Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination))
- Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month(Baseline, Final Month (last 28 days of treatment))
- Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment(Last 56 days of treatment (after 10 days from first dose date))
- Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment(Last 56 days of treatment (after 10 days from first dose date))
- Mean Change in the Number of Bleeding Days From Baseline to Month 6(Baseline, Month 6)
- Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6(Baseline, Month 6)
- Mean Change in Hemoglobin Concentration From Baseline to Final Visit(Baseline, Final Visit during treatment period (Month 6 or early termination))
- Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit(Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination))
- Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment(Baseline, second last 28 days of treatment (last 56 to 29 days of treatment))
- Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment(Baseline, third last 28 days of treatment (last 84 to 57 days of treatment))
- Change in Bleeding Severity Scores From Baseline at the Final Month(Baseline, Final Month (last 28 days of treatment))
- Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire(Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168)
- Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids(Month 6)