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临床试验/NCT01620528
NCT01620528已完成3 期

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

AbbVie (prior sponsor, Abbott)0 个研究点目标入组 872 人开始时间: 2012年5月22日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
872
主要终点
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.

详细描述

This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study.

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

  • •Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
  • •Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
  • •Agrees to use required birth control methods during the entire length of participation in the study.
  • •Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain.
  • •Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1

排除标准

  • •Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
  • •Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
  • •Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
  • •Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
  • •Subject has a history of osteoporosis or other metabolic bone disease.
  • •Subject has a current history of undiagnosed abnormal genital bleeding.

研究组 & 干预措施

Elagolix 150 mg QD

Experimental

Elagolix 150 mg once daily (QD) for the 6-month Treatment Period

干预措施: elagolix (Drug)

Elagolix 200 mg BID

Experimental

Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period

干预措施: elagolix (Drug)

Placebo

Placebo Comparator

Placebo BID for the 6-month Treatment Period

干预措施: placebo (Other)

结局指标

主要结局

Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)

时间窗: At Month 3 of Treatment Period

The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)

时间窗: At Month 3 of the Treatment Period

The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

次要结局

  • Change From Baseline to Month 6 in DYS(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores(Baseline, Month 3 of the Treatment Period)
  • Change From Baseline to Month 6 in NMPP(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 3 in Dyspareunia (DYSP)(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)(Baseline, Month 3 of Treatment Period)
  • Percentage of Responders at Month 1 Based on Daily Assessment of DYS(At Month 1 of the Treatment Period)
  • Percentage of Responders at Month 2 Based on Daily Assessment of DYS(At Month 2 of the Treatment Period)
  • Percentage of Responders at Month 4 Based on Daily Assessment of DYS(At Month 4 of the Treatment Period)
  • Percentage of Responders at Month 5 Based on Daily Assessment of DYS(At Month 5 of the Treatment Period)
  • Percentage of Responders at Month 6 Based on Daily Assessment of DYS(At Month 6 of the Treatment Period)
  • Percentage of Responders at Month 1 Based on Daily Assessment of NMPP(At Month 1 of Treatment Period)
  • Percentage of Responders at Month 2 Based on Daily Assessment of NMPP(At Month 2 of Treatment Period)
  • Percentage of Responders at Month 4 Based on Daily Assessment of NMPP(At Month 4 of Treatment Period)
  • Percentage of Responders at Month 5 Based on Daily Assessment of NMPP(At Month 5 of Treatment Period)
  • Percentage of Responders at Month 6 Based on Daily Assessment of NMPP(At Month 6 of Treatment Period)
  • Percentage of Responders at Month 1 for DYSP(At Month 1 of the Treatment Period)
  • Percentage of Responders at Month 2 for DYSP(At Month 2 of the Treatment Period)
  • Change From Baseline to Month 2 in Mean Pain Score for DYS(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 3 in Mean Pain Score for DYS(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 4 in Mean Pain Score for DYS(Baseline, Month 4 of Treatment Period)
  • Percent Change From Baseline to Month 1 in Mean Pain Score for DYS(Baseline, Month 1 of Treatment Period)
  • Percentage of Responders at Month 4 for DYSP(At Month 4 of the Treatment Period)
  • Percentage of Responders at Month 6 for DYSP(At Month 6 of the Treatment Period)
  • Change From Baseline to Month 1 in Mean Pain Score for DYS(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 5 in Mean Pain Score for DYS(Baseline, Month 5 of Treatment Period)
  • Percent Change From Baseline to Month 3 in Mean Pain Score for DYS(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 1 in Mean Pain Score for NMPP(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 2 in Mean Pain Score for NMPP(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 3 in Mean Pain Score for NMPP(Baseline, Month 3 of Treatment Period)
  • Percentage of Responders at Month 5 for DYSP(At Month 5 of the Treatment Period)
  • Percent Change From Baseline to Month 2 in Mean Pain Score for DYS(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 4 in Mean Pain Score for NMPP(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 5 in Mean Pain Score for NMPP(Baseline, Month 5 of Treatment Period)
  • Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP(Baseline, Month 1 of Treatment Period)
  • Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP(Baseline, Month 2 of Treatment Period)
  • Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP(Baseline, Month 3 of Treatment Period)
  • Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP(Baseline, Month 4 of Treatment Period)
  • Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP(Baseline, Month 5 of Treatment Period)
  • Change From Baseline to Month 2 in Mean Pain Score of DYSP(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 5 in Mean Pain Score of DYSP(Baseline, Month 5 of Treatment Period)
  • Response to Patient Global Impression of Change (PGIC) at Month 1(Month 1 of Treatment Period)
  • Response to PGIC at Month 2(Month 2 of Treatment Period)
  • Response to PGIC at Month 3(Month 3 of Treatment Period)
  • Response to PGIC at Month 4(Month 4 of Treatment Period)
  • Percent Change From Baseline to Month 4 in Mean Pain Score for DYS(Baseline, Month 4 of Treatment Period)
  • Percent Change From Baseline to Month 5 in Mean Pain Score for DYS(Baseline, Month 5 of Treatment Period)
  • Percent Change From Baseline to Month 6 in Mean Pain Score for DYS(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 6 in NRS Scores(Baseline, Month 6 of Treatment Period)
  • Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 1 in Mean Pain Score of DYSP(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 4 in Mean Pain Score of DYSP(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 3 in the Pain Domain of the EHP-30(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 6 in the Pain Domain of the EHP-30(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 6 in Mean Pain Score of DYSP(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics(Baseline, Month 5 of Treatment Period)
  • Response to PGIC at Month 5(Month 5 of Treatment Period)
  • Response to PGIC at Month 6(Month 6 of Treatment Period)
  • Change From Baseline to Month 1 in NRS Scores(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 2 in NRS Scores(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 4 in NRS Scores(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 5 in NRS Scores(Baseline, Month 5 of Treatment Period)
  • Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism(Baseline, Month 5 of Treatment Period)
  • Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism(Baseline, Month 5 of Treatment Period)
  • Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism(Baseline, Month 5 of Treatment Period)
  • Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism(Baseline, Month 6 of Treatment Period)
  • Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism(Baseline, Month 5 of Treatment Period)
  • Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household(Baseline, Month 1 of Treatment Period)
  • Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household(Baseline, Month 5 of Treatment Period)
  • Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household(Baseline, Month 6 of Treatment Period)
  • Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period(Up to Month 6 of Treatment Period)
  • Number of Days of Hospitalization(Up to Month 6 of Treatment Period)
  • Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type(Up to Month 6 of Treatment Period)
  • Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace(Baseline, Month 3 of Treatment Period)
  • Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household(Baseline, Month 2 of Treatment Period)
  • Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household(Baseline, Month 4 of Treatment Period)
  • Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace(Baseline, Month 5 of Treatment Period)
  • Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace(Baseline, Month 6 of Treatment Period)

研究者

发起方
AbbVie (prior sponsor, Abbott)
申办方类型
Industry
责任方
Sponsor

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