A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects With Endometriosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 主要终点
- Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12
研究概览
简要总结
This study is designed to see how elagolix works compared to placebo in women with endometriosis and to see the effect, if any, on bone mineral density.
详细描述
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled parallel-group study to assess the efficacy and safety of elagolix at two dose levels administered once daily for up to 6 months. Participants will be randomized (1:1:1) to one of the following treatment groups for the first 12 weeks of dosing: 150 mg elagolix once daily (QD); 250 mg elagolix QD or placebo QD. Following 12 weeks of dosing, participants will continue in the study for an additional 12 weeks; participants randomized to elagolix will continue to receive their assigned dose and participants randomized to placebo will be re-randomized to receive one of the two doses of elagolix for 12 weeks in a double-blind fashion. Six weeks after the last dose of study drug at the end of Week 24, a follow-up visit will be performed (end of Week 30).
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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be female, aged 18 to 49 years, inclusive
- •Have moderate to severe pelvic pain due to endometriosis
- •Have been surgically (laparoscopy) diagnosed with endometriosis within the last 8 years and have recurrent or persistent endometriosis symptoms
- •Have regular menstrual cycle
- •Have a body mass index (BMI) of 18 to 36 kg/m², inclusive
- •Agree to use two forms of non-hormonal contraception during the study
排除标准
- •Are currently receiving gonadotropin-releasing hormone (GnRH) agonist or GnRH antagonist or have received any of these agents within 6 months of the start of screening
- •Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening
- •Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within the last month
- •Have had surgery for endometriosis within the last month
- •Have had a hysterectomy or bilateral oophorectomy
- •Are using systemic steroids on a chronic or regular basis within 3 months
- •Have uterine fibroids ≥ 3 cm in diameter
- •Have pelvic pain that is not caused by endometriosis
- •Have unstable medical condition or chronic disease
- •Have been pregnant within the last six months
- •Currently breast feeding
研究组 & 干预措施
Placebo
Participants received placebo tablets once a day for 12 weeks. At the end of 12 weeks participants were re-randomized to receive one of the two doses of elagolix (150 mg or 250 mg) QD for 12 weeks.
干预措施: placebo (Drug)
Elagolix 150 mg
Participants received elagolix 150 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 150 mg QD for an additional 12 weeks.
干预措施: Elagolix (Drug)
Elagolix 250 mg
Participants received elagolix 250 mg tablets once a day for 12 weeks. At the end of 12 weeks participants continued to receive elagolix 250 mg for an additional 12 weeks.
干预措施: Elagolix (Drug)
结局指标
主要结局
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12
时间窗: Baseline and week 12
The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.
次要结局
- Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain(Baseline and weeks 4 and 8)
- Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score(Baseline and weeks 4, 8, and 12)
- Change From Baseline in the Monthly Mean Dysmenorrhea Score(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores(Baseline and Weeks 4, 8, and 12)
- Percentage of Days With No Pain Based on NRS(Baseline and weeks 4, 8 and 12)
- Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment(Baseline and weeks 4, 8 and 12)
- Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment(Baseline and weeks 4, 8 and 12)
- Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment(Baseline and weeks 4, 8 and 12)
- Change From Baseline in the Percentage of Days of Any Analgesic Use(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in the Percentage of Days of Prescription Analgesic Use(Baseline and Weeks 4, 8, and 12)
- Change From Baseline in the Percentage of Days of Narcotic Analgesic Use(Baseline and Weeks 4, 8, and 12)
- Percentage of Participants With 30% Decrease From Baseline in Monthly Mean NRS(Baseline and weeks 4, 8 and 12)
- Percentage of Participants With 30% Decrease From Baseline in Monthly Peak NRS(Baseline and weeks 4, 8 and 12)
- Percentage of Participants With 50% Decrease From Baseline in Monthly Mean NRS(Baseline and weeks 4, 8 and 12)
- Percentage of Participants With 50% Decrease From Baseline in Monthly Peak NRS(Baseline and weeks 4, 8 and 12)
- Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)(Baseline and Weeks 4, 8, and 12)
- Patient Global Impression of Change at Weeks 4, 8 and 12(Weeks 4, 8, and 12)
- Percentage of Participants With a PGIC Response of Minimally Improved, Much Improved, or Very Much Improved(Weeks 4, 8, and 12)
- Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved(Weeks 4, 8, and 12)
- Change From Baseline in Endometriosis Health Profile-5 (EHP-5) at Week 12(Baseline and week 12)
- Percent Change From Baseline in Bone Mineral Density of the Femur at Week 12(Baseline and week 12)
- Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24(Baseline and Week 24)
- Percent Change From Baseline in Bone Mineral Density of the Spine at Week 12(Baseline and week 12)
- Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24(Baseline and Week 24)