Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 506
- 主要终点
- Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
研究概览
简要总结
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.
详细描述
This is a Phase 3 multicenter, double blind randomized study to assess the continued safety and efficacy of the 150 mg once daily (QD) and 200 mg twice daily (BID) doses of elagolix in premenopausal women with moderate to severe endometriosis-associated pain who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.
Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg QD or elagolix 200 mg BID for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.
An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.
All participants who prematurely discontinued treatment (unless pregnant or elected surgery for endometriosis) or completed the 6-month Treatment Period in this extension study were to enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)
- •Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period
排除标准
- •Clinically significant gynecological condition
- •Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip
- •Plans to become pregnant in the next 18 months
研究组 & 干预措施
Elagolix 150 mg QD
Participants received elagolix 150 mg tablets once a day (QD) for 6 months.
干预措施: Elagolix (Drug)
Elagolix 200 mg BID
Participants received elagolix 200 mg tablets twice a day (BID) for 6 months.
干预措施: Elagolix (Drug)
结局指标
主要结局
Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
时间窗: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6
Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment
时间窗: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6
Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.
次要结局
- Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5)
- Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5)
- Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6)
- Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6)
- Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6)
- Change From Baseline in NSAID Rescue Analgesic Use(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6)
- Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS)(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6)
- Percent Change From Baseline in Dyspareunia Based on Daily Assessment(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6)
- Change From Baseline in Any Rescue Analgesic Use(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6)
- Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6)
- Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and month 6)
- Number of Participants With Non-study Health Visits During the Treatment Period(6 months)
- Change From Baseline in Opioid Rescue Analgesic Use(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6)
- Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved(Months 1, 2, 3, 4, 5, and 6)
- Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension(Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6)
- Number of Days in Hospital During the Treatment Period(6 months)