A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 413
- 试验地点
- 96
- 主要终点
- Percentage of Participants Meeting the Criteria for Responder
研究概览
简要总结
This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
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 a premenopausal female at the time of Screening.
- •Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound (transabdominal ultrasound/transvaginal ultrasound).
- •Subject has heavy menstrual bleeding associated with uterine fibroids as evidenced by menstrual blood loss > 80 mL during each of two screening menses as measured by the alkaline hematin method.
- •Subject has negative urine and/or serum pregnancy test in Screening and just prior to first dose.
- •Subject has an adequate endometrial biopsy performed during Screening, the results of which show no clinically significant endometrial pathology.
排除标准
- •Subject has screening pelvic ultrasound or saline infusion sonohysterography results that show a clinically significant gynecological disorder.
- •Subject has history of osteoporosis or other metabolic bone disease.
- •Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
- •Subject has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years of screening, OR a history of other major psychiatric disorder at any time (e.g., schizophrenia, bipolar disorder).
- •Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening 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
Placebo
Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/NETA) once daily (QD)
干预措施: Placebo for Estradiol/Norethindrone Acetate (Drug)
Placebo
Placebo for both elagolix twice daily (BID) and norethindrone acetate (E2/NETA) once daily (QD)
干预措施: Placebo for 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)
Elagolix
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
干预措施: Placebo for Estradiol/Norethindrone Acetate (Drug)
Elagolix + E2/NETA
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
干预措施: Elagolix (Drug)
Elagolix + E2/NETA
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
干预措施: Estradiol/Norethindrone Acetate (Drug)
结局指标
主要结局
Percentage of Participants Meeting the Criteria for Responder
时间窗: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
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 Reference Day, which is defined as the last visit date during the Treatment Period \[last treatment visit date\] or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on 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
- Change From Baseline in MBL Volume to the Final Month(Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6)
- Percentage of Participants With Suppression of Bleeding at the Final Month(Final Month (the last 28 days prior to and including the Reference Day), up to Month 6)
- Change From Baseline in MBL Volume to Month 6(Month 0 (Baseline), Month 6)
- Change From Baseline in MBL Volume to Month 3(Month 0 (Baseline), Month 3)
- Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6(Month 0 (Baseline), Month 6)
- Change From Baseline in MBL Volume to Month 1(Month 0 (Baseline), Month 1)