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

Trial ID:
IRB-13-6229
Bruce Kahn
A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female subjects.

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 the Washout Period.
  • 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 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.

Contact Info:

  • Cynthia Mattia-Goldberg, MS
  • cynthia.mattia-goldberg@abbvie.com
  • 847-938-1460