Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 433
- 试验地点
- 124
- 主要终点
- Percentage of Participants Meeting the Criteria for Responder
研究概览
简要总结
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated 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
- •Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
- •Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
- •Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
- •Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.
排除标准
- •Participant met criteria for removal from therapy in her respective Pivotal Study.
- •Participant is planning a pregnancy within the next 18 months.
- •Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
- •Participant has any new medical conditions that may be unsuitable for participation.
- •Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
研究组 & 干预措施
Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)
Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD)
干预措施: Estradiol/Norethindrone Acetate (Drug)
Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA)
Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD)
干预措施: Elagolix (Drug)
Elagolix
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
干预措施: Elagolix (Drug)
结局指标
主要结局
Percentage of Participants Meeting the Criteria for Responder
时间窗: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
次要结局
- Percentage of Participants With Suppression of Bleeding at the Final Month(Final Month of Treatment Period (up through Month 6))
- Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period(Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6))
- Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period(Month 6)
- Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period(Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6))