A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: elagolix; estradiol/norethindrone acetate (E2/NETA)
Intervention description: Tablets; Capsules
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Endometriosis associated pain; Elagolix; Non-menstrual pelvic pain (NMPP); Dysmenorrhea (DYS)

Summary:

      This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both
      elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in
      the management of endometriosis with associated moderate to severe pain in premenopausal
      women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of
             Screening.

          -  Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of
             endometriosis established by visualization or histology within 10 years prior to entry
             into Washout or Screening,

          -  Participant must agree to use only those rescue analgesics permitted by the protocol
             during the Screening and Treatment Periods for her endometriosis-associated pain.

          -  Participant must have the following documented in the e-Diary during the last 35 days
             prior to Study Day 1:

               1. At least 2 days of "moderate" or "severe" DYS, AND either,

               2. At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at
                  least 1.0, OR

               3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at
                  least 0.5.

        Exclusion Criteria:

          -  Participant has chronic pelvic pain that is not caused by endometriosis that requires
             chronic analgesic therapy, which would interfere with the assessment of
             endometriosis-associated pain.

          -  Participant 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 or
             intranasal corticosteroids are allowed.

          -  Participant has a history of major depression or post-traumatic stress disorder (PTSD)
             within 2 years prior to screening or other major psychiatric disorder at any time

          -  Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on
             the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS)
             at Screening or prior to study drug dosing on Day 1.

          -  Participant has any condition that would interfere with obtaining adequate dual energy
             x-ray absorptiometry (DXA) measurements

          -  Screening DXA results of the lumbar spine (L1 - L4), femoral neck or total hip bone
             mineral density (BMD) corresponding to less than 2 or more standard deviations below
             normal (Z-score < -2.0 for participants < 40 years of age, T-score for participants >=
             40 years of age).

          -  Participant has either

               1. a newly diagnosed, clinically significant medical condition that requires
                  therapeutic intervention (e.g., new onset hypertension) that has not been
                  stabilized 30 days prior to enrollment on Day 1 OR

               2. a clinically significant medical condition that is anticipated to required
                  intervention during the course of study participation (e.g., anticipated major
                  elective surgery) OR

               3. an unstable medical condition that makes the participant an unsuitable candidate
                  for the study in the opinion of the Investigator

          -  Participant has any conditions contraindicated with use of E2/NETA