Status:
TERMINATED
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
Lead Sponsor:
AbbVie
Conditions:
Endometriosis
Eligibility:
FEMALE
18-49 years
Phase:
PHASE3
Brief 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 managemen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03343067
Start Date
December 27 2017
End Date
October 23 2018
Last Update
November 27 2019
Active Locations (37)
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1
Pinnacle Research Group /ID# 202016
Anniston, Alabama, United States, 36207
2
Noble Clinical Research /ID# 170628
Tucson, Arizona, United States, 85704
3
Lynn Institute of the Ozarks /ID# 165052
Little Rock, Arkansas, United States, 72205
4
SC Clinical Research /ID# 165049
Garden Grove, California, United States, 92844