A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

Stopped early · Phase 3

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT03343067

Run by

AbbVie

People needed

11

Starts

2017-12-27

Expected to finish

2018-10-23

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• At least 2 days of "moderate" or "severe" DYS, AND either,
• At least 2 days of "moderate" or "severe" NMPP and an average NMPP score of at least 1.0, OR
• At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.

You may not qualify if…

• 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
• 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
• a clinically significant medical condition that is anticipated to required intervention during the course of study participation (e.g., anticipated major elective surgery) OR
• 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

Where it is running

• Pinnacle Research Group /ID# 202016 — Anniston, Alabama, United States
• Noble Clinical Research /ID# 170628 — Tucson, Arizona, United States
• Lynn Institute of the Ozarks /ID# 165052 — Little Rock, Arkansas, United States
• SC Clinical Research /ID# 165049 — Garden Grove, California, United States
• Marvel Clinical Research /ID# 169633 — Huntington Beach, California, United States
• Health care Affiliates Medical Group /ID# 165048 — Santa Ana, California, United States
• Western States Clinical Res /ID# 169809 — Wheat Ridge, Colorado, United States
• Nova Clinical Research, LLC /ID# 202227 — Bradenton, Florida, United States
• Midland Florida Clinical Research Center /ID# 201327 — DeLand, Florida, United States
• Southeastern Integrated Med /ID# 203109 — Gainesville, Florida, United States
• Care Partners Clinical Researc /ID# 168395 — Jacksonville, Florida, United States
• LCC Medical Research Institute /ID# 168888 — Miami, Florida, United States
• A Premier Clinical Research of Florida, LLC /ID# 201887 — Orange City, Florida, United States
• GCP Clinical Research, LLC /ID# 169774 — Tampa, Florida, United States
• Triple O Research Institute /ID# 201128 — West Palm Beach, Florida, United States
• Bingham Memorial Hospital /ID# 170110 — Blackfoot, Idaho, United States
• Leavitt Womens Healthcare /ID# 169495 — Idaho Falls, Idaho, United States
• Quad Clinical Research, LLC /ID# 168294 — Chicago, Illinois, United States
• Quad Clinical Research, LLC /ID# 170629 — Chicago, Illinois, United States
• Women's Health Care, PC /ID# 165033 — Newburgh, Indiana, United States
• Delricht Research /ID# 200219 — New Orleans, Louisiana, United States
• Quad Clinical Research, LLC /ID# 200180 — St Louis, Missouri, United States
• Montana Health Research Inst /ID# 170624 — Billings, Montana, United States
• Excel Clinical Research /ID# 170620 — Las Vegas, Nevada, United States
• Northwell health system /ID# 200162 — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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