Clinical trial NCT01620528: A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Keywords: Gonadotropin-Releasing Hormone Antagonist
Endometriosis associated pain
Dysmenorrhea (DYS)
Non-Menstrual Pelvic Pain (NMPP)
Elagolix
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 872
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
3. Agrees to use required birth control methods during the entire length of participation in the study.
4. 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. 5. Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1

Exclusion Criteria:

1. 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.
2. 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).
3. 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.
4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
5. Subject has a history of osteoporosis or other metabolic bone disease.
6. Subject has a current history of undiagnosed abnormal genital bleeding.

Primary outcomes:
measure: Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
timeFrame: At Month 3 of the Treatment Period
measure: Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
timeFrame: At Month 3 of Treatment Period
Secondary outcomes:
measure: Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
timeFrame: Baseline, Month 3 of the Treatment Period
measure: Change From Baseline to Month 6 in DYS
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 6 in NMPP
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 3 in Dyspareunia (DYSP)
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
timeFrame: Baseline, Month 3 of Treatment Period
measure: Percentage of Responders at Month 1 Based on Daily Assessment of DYS
timeFrame: At Month 1 of the Treatment Period
measure: Percentage of Responders at Month 2 Based on Daily Assessment of DYS
timeFrame: At Month 2 of the Treatment Period
measure: Percentage of Responders at Month 4 Based on Daily Assessment of DYS
timeFrame: At Month 4 of the Treatment Period
measure: Percentage of Responders at Month 5 Based on Daily Assessment of DYS
timeFrame: At Month 5 of the Treatment Period
measure: Percentage of Responders at Month 6 Based on Daily Assessment of DYS
timeFrame: At Month 6 of the Treatment Period
measure: Percentage of Responders at Month 1 Based on Daily Assessment of NMPP
timeFrame: At Month 1 of Treatment Period
measure: Percentage of Responders at Month 2 Based on Daily Assessment of NMPP
timeFrame: At Month 2 of Treatment Period
measure: Percentage of Responders at Month 4 Based on Daily Assessment of NMPP
timeFrame: At Month 4 of Treatment Period
measure: Percentage of Responders at Month 5 Based on Daily Assessment of NMPP
timeFrame: At Month 5 of Treatment Period
measure: Percentage of Responders at Month 6 Based on Daily Assessment of NMPP
timeFrame: At Month 6 of Treatment Period
measure: Percentage of Responders at Month 1 for DYSP
timeFrame: At Month 1 of the Treatment Period
measure: Percentage of Responders at Month 2 for DYSP
timeFrame: At Month 2 of the Treatment Period
measure: Percentage of Responders at Month 4 for DYSP
timeFrame: At Month 4 of the Treatment Period
measure: Percentage of Responders at Month 5 for DYSP
timeFrame: At Month 5 of the Treatment Period
measure: Percentage of Responders at Month 6 for DYSP
timeFrame: At Month 6 of the Treatment Period
measure: Change From Baseline to Month 1 in Mean Pain Score for DYS
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in Mean Pain Score for DYS
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 3 in Mean Pain Score for DYS
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 4 in Mean Pain Score for DYS
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in Mean Pain Score for DYS
timeFrame: Baseline, Month 5 of Treatment Period
measure: Percent Change From Baseline to Month 1 in Mean Pain Score for DYS
timeFrame: Baseline, Month 1 of Treatment Period
measure: Percent Change From Baseline to Month 2 in Mean Pain Score for DYS
timeFrame: Baseline, Month 2 of Treatment Period
measure: Percent Change From Baseline to Month 3 in Mean Pain Score for DYS
timeFrame: Baseline, Month 3 of Treatment Period
measure: Percent Change From Baseline to Month 4 in Mean Pain Score for DYS
timeFrame: Baseline, Month 4 of Treatment Period
measure: Percent Change From Baseline to Month 5 in Mean Pain Score for DYS
timeFrame: Baseline, Month 5 of Treatment Period
measure: Percent Change From Baseline to Month 6 in Mean Pain Score for DYS
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 3 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 4 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 5 of Treatment Period
measure: Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 1 of Treatment Period
measure: Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 2 of Treatment Period
measure: Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 3 of Treatment Period
measure: Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 4 of Treatment Period
measure: Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 5 of Treatment Period
measure: Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in Mean Pain Score of DYSP
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in Mean Pain Score of DYSP
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 4 in Mean Pain Score of DYSP
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in Mean Pain Score of DYSP
timeFrame: Baseline, Month 5 of Treatment Period
measure: Change From Baseline to Month 6 in Mean Pain Score of DYSP
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics
timeFrame: Baseline, Month 5 of Treatment Period
measure: Response to Patient Global Impression of Change (PGIC) at Month 1
timeFrame: Month 1 of Treatment Period
measure: Response to PGIC at Month 2
timeFrame: Month 2 of Treatment Period
measure: Response to PGIC at Month 3
timeFrame: Month 3 of Treatment Period
measure: Response to PGIC at Month 4
timeFrame: Month 4 of Treatment Period
measure: Response to PGIC at Month 5
timeFrame: Month 5 of Treatment Period
measure: Response to PGIC at Month 6
timeFrame: Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in NRS Scores
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in NRS Scores
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 4 in NRS Scores
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in NRS Scores
timeFrame: Baseline, Month 5 of Treatment Period
measure: Change From Baseline to Month 6 in NRS Scores
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 3 in the Pain Domain of the EHP-30
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 6 in the Pain Domain of the EHP-30
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
timeFrame: Baseline, Month 5 of Treatment Period
measure: Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
timeFrame: Baseline, Month 5 of Treatment Period
measure: Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
timeFrame: Baseline, Month 5 of Treatment Period
measure: Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
timeFrame: Baseline, Month 5 of Treatment Period
measure: Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
timeFrame: Baseline, Month 5 of Treatment Period
measure: Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace
timeFrame: Baseline, Month 6 of Treatment Period
measure: Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
timeFrame: Baseline, Month 1 of Treatment Period
measure: Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
timeFrame: Baseline, Month 2 of Treatment Period
measure: Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
timeFrame: Baseline, Month 3 of Treatment Period
measure: Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
timeFrame: Baseline, Month 4 of Treatment Period
measure: Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
timeFrame: Baseline, Month 5 of Treatment Period
measure: Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household
timeFrame: Baseline, Month 6 of Treatment Period
measure: Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period
timeFrame: Up to Month 6 of Treatment Period
measure: Number of Days of Hospitalization
timeFrame: Up to Month 6 of Treatment Period
measure: Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type
timeFrame: Up to Month 6 of Treatment Period
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Rachel Duan, MD
role: STUDY_DIRECTOR
References:
citation: Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19.
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citation: Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8.
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