A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain
NCT ID: NCT03343067
Last Updated: 2019-11-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
11 participants
INTERVENTIONAL
2017-12-27
2018-10-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD
Month 4 Through Month 24 (Double-Blind): Efficacy responders to elagolix 150 mg QD at Month 3 and continue treatment through Month 24
elagolix
Tablets
Arm C
Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD
Month 4 Through Month 24 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group and continue treatment through Month 24.
elagolix
Tablets
estradiol/norethindrone acetate (E2/NETA)
Capsules
Arm D
Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD
Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 150 mg QD treatment group
Month 7 Through Month 24 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 6 and assigned to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group and continue treatment through Month 24.
elagolix
Tablets
estradiol/norethindrone acetate (E2/NETA)
Capsules
Arm B
Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD
Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 150 mg QD treatment group
Month 7 Through Month 24 (Double-Blind): Efficacy responders to elagolix 150 mg QD at Month 6 and continue treatment through Month 24.
elagolix
Tablets
Interventions
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elagolix
Tablets
estradiol/norethindrone acetate (E2/NETA)
Capsules
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
49 Years
FEMALE
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Radiant Research, Inc /ID# 200045
Akron, Ohio, United States
Central Ohio Clinical Research /ID# 170750
Columbus, Ohio, United States
Optimed Research /ID# 167642
Columbus, Ohio, United States
VitaLink Research /ID# 168401
Greenville, South Carolina, United States
VitaLink Research /ID# 170625
Greenville, South Carolina, United States
Fusion Clinical Research of Spartanburg /ID# 200010
Spartanburg, South Carolina, United States
Centex Studies, Inc /ID# 169897
Houston, Texas, United States
America's Adv. Wellness Center /ID# 170005
Houston, Texas, United States
ClinRx Research, LLC /ID# 201189
Plano, Texas, United States
Progressive Clinical Research /ID# 205565
San Antonio, Texas, United States
Eastern Virginia Med School /ID# 165016
Norfolk, Virginia, United States
Seattle Reproductive Medicine /ID# 171079
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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M16-383
Identifier Type: -
Identifier Source: org_study_id
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