A Clinical Study to Evaluate the Safety and Efficacy of E... | NCT03213457 | Trialant
NCT03213457
Sponsor
AbbVie
Status
Completed
Last Update Posted
Dec 20, 2024Actual
Enrollment
681Actual
Phase
Phase 3
Conditions
Endometriosis
Interventions
Estradiol/Norethindrone Acetate
Placebo for Elagolix
Elagolix
Placebo for E2/NETA
Countries
United States
Canada
Puerto Rico
Protocol Section
Identification Module
NCT ID
NCT03213457
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M14-702
Secondary IDs
Not provided
Brief Title
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Official Title
A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Nov 2024
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 7, 2017Actual
Primary Completion Date
Mar 27, 2020Actual
Completion Date
Dec 6, 2023Actual
First Submitted Date
Jul 7, 2017
First Submission Date that Met QC Criteria
Jul 7, 2017
First Posted Date
Jul 11, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Mar 24, 2021
Results First Submitted that Met QC Criteria
Mar 24, 2021
Results First Posted Date
Apr 20, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 25, 2024
Last Update Posted Date
Dec 20, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.
Detailed Description
Not provided
Conditions Module
Conditions
Endometriosis
Keywords
Elagolix
Endometriosis associated pain
Dysmenorrhea (DYS)
Non-menstrual pelvic pain (NMPP)
ORILISSA
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
681Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Drug: Placebo for Elagolix
Drug: Placebo for E2/NETA
Elagolix / Elagolix + E2/NETA
Experimental
Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Drug: Estradiol/Norethindrone Acetate
Drug: Elagolix
Elagolix + E2/NETA
Experimental
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Drug: Estradiol/Norethindrone Acetate
Drug: Elagolix
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Estradiol/Norethindrone Acetate
Drug
Tablets
Elagolix + E2/NETA
Elagolix / Elagolix + E2/NETA
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment
Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over 35 days prior to each visit.
Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic).
Month 6, Month 12
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Response was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics).
Month 6, Month 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in DYS at Month 12 Based on Daily Assessment
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.
Other Outcomes
Not provided
Eligibility Module
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 within 10 years prior to entry into Washout or Screening.
Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for 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" dysmenorrhea (DYS) AND either
At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (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 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-related 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 any major depression or post-traumatic stress disorder (PTSD) within 2 years of the screening visit 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) within the last 1 year at Screening or prior to randomization on Day 1.
Participant has any history of osteoporosis or other metabolic bone disease or 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 2.0 or more standard deviations below normal.
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 randomization on Day 1 OR
a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR
an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the Investigator, (including, but not limited to, uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).
Participant has any conditions contraindicated with use of E2/NETA.
Watts NB, Binkley N, Owens CD, Al-Hendy A, Puscheck EE, Shebley M, Schlaff WD, Simon JA. Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life. J Womens Health (Larchmt). 2021 Oct;30(10):1416-1430. doi: 10.1089/jwh.2020.8989. Epub 2021 Aug 25.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Participants were randomly assigned on Study Day 1 in a 4:1:2 ratio as follows:
elagolix 200 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) 1 mg/0.5 mg once daily (QD)
elagolix 200 mg BID
placebo
Data are presented for the 12-month Placebo-Controlled Treatment Period.
Recruitment Details
A total of 679 subjects were treated at 137 sites in 2 countries (US [including Puerto Rico] and Canada). Of the 679 subjects who were treated on study, 299 subjects discontinued study drug prematurely during the Placebo-Controlled Treatment Period and 240 discontinued study drug prematurely during the Open-Label Treatment Period.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Change From Baseline in DYS at Month 6 Based on Daily Assessment
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
Mild discomfort but I was easily able to do the things I usually do
Moderate discomfort or pain that made it difficult to do some of the things I usually do
Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.
Baseline, Month 6
Change From Baseline in DYS at Month 3 Based on Daily Assessment
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
Mild discomfort but I was easily able to do the things I usually do
Moderate discomfort or pain that made it difficult to do some of the things I usually do
Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.
Baseline, Month 3
Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Baseline, Month 12
Change From Baseline in NMPP at Month 6 Based on Daily Assessment
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Baseline, Month 6
Change From Baseline in NMPP at Month 3 Based on Daily Assessment
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Baseline, Month 3
Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Baseline, Month 6
Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment
Participants assessed DYSP each day in an e-Diary according to the following response options:
0: None; No discomfort during sexual intercourse
1: Mild; Able to tolerate the discomfort during sexual intercourse
2: Moderate; Intercourse was interrupted due to pain
3: Severe; Avoided intercourse because of pain
Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Baseline, Month 12
Change From Baseline in DYSP at Month 6 Based on Daily Assessment
Participants assessed DYSP each day in an e-Diary according to the following response options:
0: None; No discomfort during sexual intercourse
1: Mild; Able to tolerate the discomfort during sexual intercourse
2: Moderate; Intercourse was interrupted due to pain
3: Severe; Avoided intercourse because of pain
Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Baseline, Month 6
Change From Baseline in DYSP at Month 3 Based on Daily Assessment
Participants assessed DYSP each day in an e-Diary according to the following response options:
0: None; No discomfort during sexual intercourse
1: Mild; Able to tolerate the discomfort during sexual intercourse
2: Moderate; Intercourse was interrupted due to pain
3: Severe; Avoided intercourse because of pain
Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Baseline, Month 3
Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Baseline, Month 12
Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Baseline, Month 12
Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Baseline, Month 6
Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Baseline, Month 3
Birmingham
Alabama
35235-3430
United States
Alabama Clinical Therapeutics, LLC /ID# 151468
Birmingham
Alabama
35235-3430
United States
Southern Women's Specialists PC /ID# 148750
Fairhope
Alabama
36532-3029
United States
Women's Health Alliance of Mobile /ID# 150083
Mobile
Alabama
36604-1410
United States
University of South Alabama /ID# 148774
Mobile
Alabama
36604-3302
United States
Mobile, Ob-Gyn, P.C. /ID# 145364
Mobile
Alabama
36608
United States
Mesa Obstetricians and Gynecologists /ID# 147320
Mesa
Arizona
85209
United States
Arizona Research Assoc /ID# 161703
Tucson
Arizona
85712
United States
Eclipse Clinical Research /ID# 155600
Tucson
Arizona
85745
United States
Unity Health- Searcy Medical Center /ID# 203674
Searcy
Arkansas
72143-4802
United States
Core Healthcare Group /ID# 149321
Cerritos
California
90703
United States
HRC Fertility /ID# 154143
Encino
California
91436
United States
Glendale Adventist Medical Ctr /ID# 160530
Glendale
California
91206
United States
HCP Clinical Research LLC /ID# 152045
Huntington Beach
California
92646
United States
Alliance Research Centers /ID# 151240
Irvine
California
92612-1245
United States
Long Beach Clinical Trial Serv /ID# 152428
Long Beach
California
90806
United States
Olympia Clinical Trials /ID# 202325
Los Angeles
California
90036-4667
United States
California Medical Research As /ID# 154746
Northridge
California
91324
United States
Futura Research, Org /ID# 145406
Norwalk
California
90650
United States
Huntington Medical Foundation /ID# 154750
Pasadena
California
91105
United States
Northern California Research /ID# 159753
Sacramento
California
95821-2640
United States
Precision Research Institute - San Diego /ID# 152557
San Diego
California
92114-3643
United States
MD Strategies Research Centers /ID# 152429
San Diego
California
92119
United States
Alta California Medical Group /ID# 155706
Simi Valley
California
93065
United States
Downtown Womens Health Care /ID# 147955
Denver
Colorado
80209
United States
Advanced Women's Health Institute /ID# 145396
Greenwood Village
Colorado
80111
United States
Red Rocks OB/GYN /ID# 145325
Lakewood
Colorado
80228-1810
United States
The Women's Health Group - Thornton /ID# 203707
Thornton
Colorado
80229-4385
United States
James A. Simon, MD, PC /ID# 145480
Washington D.C.
District of Columbia
20036
United States
Helix Biomedics, LLC /ID# 147108
Boynton Beach
Florida
33436-6634
United States
Gulf Coast Research Group /ID# 162895
Brandon
Florida
33510
United States
Olympian Clinical Research /ID# 148167
Clearwater
Florida
33756
United States
Omega Research Maitland, LLC /ID# 145167
DeBary
Florida
32713-2260
United States
KO Clinical Research, LLC /ID# 145410
Fort Lauderdale
Florida
33316
United States
Clinical Physiology Associates /ID# 145237
Fort Myers
Florida
33912
United States
Solutions Through Adv Rch /ID# 148768
Jacksonville
Florida
32256
United States
Vida Clinical Research /ID# 150282
Kissimmee
Florida
34741-2345
United States
Axcess Medical Center /ID# 148169
Loxahatchee Groves
Florida
33470
United States
Genoma Research Group, Inc /ID# 152558
Miami
Florida
33165
United States
Vista Health Research LLC - Miami /ID# 151455
Miami
Florida
33176-1032
United States
Palmetto Professional Research /ID# 153838
Miami
Florida
33186-1309
United States
Precision Research Organization /ID# 145337
Miami Lakes
Florida
33016-1501
United States
Ocean Blue Medical Research Center, Inc /ID# 145514
Miami Springs
Florida
33166
United States
Salom Tangir, LLC /ID# 148739
Miramar
Florida
33027
United States
Suncoast Clinical Research /ID# 145484
New Port Richey
Florida
34652
United States
Oncova Clinical Research, Inc. /ID# 148175
Saint Cloud
Florida
34769
United States
Physician Care Clin. Res., LLC /ID# 145511
Sarasota
Florida
34239
United States
Meridien Research - St Petersburg /ID# 145345
St. Petersburg
Florida
33709-3113
United States
Treasure Coast Research /ID# 148174
Stuart
Florida
34996
United States
University of South Florida /ID# 145424
Tampa
Florida
33612
United States
Stedman Clinical Trials /ID# 152554
Tampa
Florida
33613
United States
Virtus Research Consultants, LLC /ID# 147101
Wellington
Florida
33414
United States
Comprehensive Clinical Trials /ID# 145148
West Palm Beach
Florida
33409
United States
Paramount Research Solutions /ID# 145226
Alpharetta
Georgia
30005
United States
Paramount Research Solutions /ID# 149320
Alpharetta
Georgia
30005
United States
Agile Clinical Research Trials /ID# 145494
Atlanta
Georgia
30328-5532
United States
Atlanta Women's Research Inst /ID# 145543
Atlanta
Georgia
30342
United States
Apogee Women's Health Inc. /ID# 145149
College Park
Georgia
30349
United States
Columbus Regional Research Ins /ID# 159752
Columbus
Georgia
31904
United States
Meridian Clinical Research, LLC /ID# 148176
Savannah
Georgia
31406-2675
United States
Atlanta Gynecology Research Institute /ID# 149322
Suwanee
Georgia
30024-7159
United States
Clinical Research Prime /ID# 161724
Idaho Falls
Idaho
83404
United States
Womens Healthcare Assoc, DBA /ID# 148744
Idaho Falls
Idaho
83404
United States
Advanced Clinical Research /ID# 147086
Meridian
Idaho
83642
United States
Sonora Clinical Research /ID# 145541
Meridian
Idaho
83646-1144
United States
Asr, Llc /Id# 161680
Nampa
Idaho
83687
United States
Women's Health Practice, LLC /ID# 145517
Champaign
Illinois
61820
United States
Affinity Clinical Research /ID# 151469
Oak Brook
Illinois
60523
United States
Center for Women's Research, Inc /ID# 145486
Palos Heights
Illinois
60463-1440
United States
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459
Park Ridge
Illinois
60068
United States
American Health Network of Ind /ID# 167996
Avon
Indiana
46123-7960
United States
Women's Health Advantage /ID# 145495
Fort Wayne
Indiana
46825
United States
The Iowa Clinic /ID# 145409
West Des Moines
Iowa
50266
United States
Womens & Family Care, LLC dba /ID# 145211
Shawnee Mission
Kansas
66218
United States
PRN Professional Research Network of Kansas, LLC /ID# 151463
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546
San Juan
00935
Puerto Rico
Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
FG002
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
FG000194 subjects
FG00198 subjects
FG002389 subjects
COMPLETED
FG000193 subjects
FG00197 subjects
FG002389 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
Double-Blind Period
Type
Comment
Milestone Data
STARTED
Includes all treated participants who received at least one dose of study drug.
FG000193 subjects
FG00197 subjects
FG002389 subjects
COMPLETED
FG000157 subjects
FG00185 subjects
FG002337 subjects
NOT COMPLETED
FG00036 subjects
FG00112 subjects
FG00252 subjects
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0012 subjects
FG0027 subjects
Withdrawal by Subject
FG000
Open-Label Period
Type
Comment
Milestone Data
STARTED
Includes participants who completed the Placebo-Controlled Treatment Period and entered the Open-Label Treatment Period.
FG000106 subjects
FG00159 subjects
FG002215 subjects
COMPLETED
FG00090 subjects
FG00148 subjects
FG002170 subjects
NOT COMPLETED
FG00016 subjects
FG00111 subjects
FG00245 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0022 subjects
Withdrawal by Subject
FG000
Follow-Up Period
Type
Comment
Milestone Data
STARTED
Includes all randomized participants. Participants were expected to enter the Follow-Up Period after Treatment Month 48, or if a participant prematurely discontinued from the Treatment Period at the time of or after Treatment Month 6.
FG000194 subjects
FG00198 subjects
FG002389 subjects
COMPLETED
FG000102 subjects
FG00151 subjects
FG002185 subjects
NOT COMPLETED
FG00092 subjects
FG00147 subjects
FG002204 subjects
Type
Comment
Reasons
Adverse Event
FG00016 subjects
FG0018 subjects
FG00237 subjects
Withdrawal by Subject
FG000
Full Analysis Set: all randomized participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
BG001
Elagolix / Elagolix + E2/NETA
Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
BG002
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000193
BG00197
BG002389
BG003679
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00033.1± 6.72
BG00132.5± 6.44
BG00232.3± 6.74
BG003
Sex/Gender, Customized
Count of Participants
Participants
Title
Denominators
Categories
Female
Title
Measurements
BG000193
BG00197
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00037
BG00111
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0001
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment
Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over 35 days prior to each visit.
Response was defined as a reduction of -0.92 or more from baseline in DYS as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic).
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Number
95% Confidence Interval
percentage of participants
Month 6, Month 12
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Units
Counts
Participants
OG000190
OG001384
Title
Denominators
Categories
Month 6
ParticipantsOG000190
ParticipantsOG001384
Title
Measurements
OG00023.7(17.64 to 29.73)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 6
Regression, Logistic
< 0.001
P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
5.51
2-Sided
95
3.711
8.176
Superiority
OG000
OG001
Primary
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Response was defined as a reduction of -0.55 or greater from baseline for NMPP as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics).
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Number
95% Confidence Interval
percentage of participants
Month 6, Month 12
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Secondary
Change From Baseline in DYS at Month 12 Based on Daily Assessment
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 12
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in DYS at Month 6 Based on Daily Assessment
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
Mild discomfort but I was easily able to do the things I usually do
Moderate discomfort or pain that made it difficult to do some of the things I usually do
Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 6
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in DYS at Month 3 Based on Daily Assessment
Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
Mild discomfort but I was easily able to do the things I usually do
Moderate discomfort or pain that made it difficult to do some of the things I usually do
Severe pain that made it difficult to do the things I usually do.
Pain scores were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 3
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 12
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in NMPP at Month 6 Based on Daily Assessment
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 6
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in NMPP at Month 3 Based on Daily Assessment
Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following:
0: No discomfort
1: Mild discomfort but I was easily able to do the things I usually do
2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
3: Severe pain that made it difficult to do the things I usually do.
Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 3
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
T-score
Baseline, Month 6
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment
Participants assessed DYSP each day in an e-Diary according to the following response options:
0: None; No discomfort during sexual intercourse
1: Mild; Able to tolerate the discomfort during sexual intercourse
2: Moderate; Intercourse was interrupted due to pain
3: Severe; Avoided intercourse because of pain
Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 12
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in DYSP at Month 6 Based on Daily Assessment
Participants assessed DYSP each day in an e-Diary according to the following response options:
0: None; No discomfort during sexual intercourse
1: Mild; Able to tolerate the discomfort during sexual intercourse
2: Moderate; Intercourse was interrupted due to pain
3: Severe; Avoided intercourse because of pain
Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 6
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in DYSP at Month 3 Based on Daily Assessment
Participants assessed DYSP each day in an e-Diary according to the following response options:
0: None; No discomfort during sexual intercourse
1: Mild; Able to tolerate the discomfort during sexual intercourse
2: Moderate; Intercourse was interrupted due to pain
3: Severe; Avoided intercourse because of pain
Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.
Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 3
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
T-score
Baseline, Month 12
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 12
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 6
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Secondary
Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.
Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 3
ID
Title
Description
OG000
Placebo
Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
OG001
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA [1 mg/0.5 mg] QD for the remaining 36 months of the Treatment Period.
Time Frame
All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events(AEs): From first dose of study drug through the end of the Treatment Period (Month 12).
Description
Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment.
Arm counts include all randomized participants.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
SCR_Placebo
Screening (SCR) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
194
0
194
1
194
EG001
SCR_Elagolix
Screening (SCR) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
98
0
98
0
98
EG002
SCR_Elagolix_and_E2-NETA
Screening (SCR) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
389
1
389
1
389
EG003
DB_Placebo
Double-blinded (DB) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
194
8
194
89
194
EG004
DB_Elagolix
Double-blinded (DB) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
98
2
98
74
98
EG005
DB_Elagolix_and_E2-NETA
Double-blinded (DB) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
389
14
389
236
389
EG006
OL_Placebo_to_ELA_and_E2-NETA
Open-Label (OL) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
106
7
106
60
106
EG007
OL_ELA_to_ELA_and_E2-NETA
Open-Label (OL) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
59
2
59
32
59
EG008
OL_ELA_and_E2-NETA_to_ELA_and_E2-NETA
Open-Label (OL) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
215
10
215
125
215
EG009
FU_Placebo_to_ELA_and_E2-NETA
Follow-Up (FU) Period: Placebo for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
194
2
194
2
194
EG010
FU_ELA_to_ELA_and_E2-NETA
Follow-Up (FU) Period: Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
98
0
98
3
98
EG011
FU_ELA_and_E2-NETA_to_ELA_and_E2-NETA
Follow-Up (FU) Period: Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
0
389
1
389
6
389
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
SINUS NODE DYSFUNCTION
Cardiac disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG0030 events0 affected194 at risk
EG0040 events0 affected98 at risk
EG0051 events1 affected389 at risk
EG0060 events0 affected106 at risk
EG0070 events0 affected59 at risk
EG0080 events0 affected215 at risk
EG0090 events0 affected194 at risk
EG0100 events0 affected98 at risk
EG0110 events0 affected389 at risk
VESTIBULAR DISORDER
Ear and labyrinth disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
PITUITARY APOPLEXY
Endocrine disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
FOOD POISONING
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
INTESTINAL PERFORATION
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
UMBILICAL HERNIA
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
BILIARY COLIC
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
CHOLECYSTITIS CHRONIC
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
CHOLELITHIASIS
Hepatobiliary disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected389 at risk
EG003
ABSCESS INTESTINAL
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
COVID-19 PNEUMONIA
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ALCOHOL POISONING
Injury, poisoning and procedural complications
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
DIABETIC KETOACIDOSIS
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
OBESITY
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
SPONDYLOLISTHESIS
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
PITUITARY TUMOUR
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
SEIZURE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
VESTIBULAR MIGRAINE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ABORTION SPONTANEOUS
Pregnancy, puerperium and perinatal conditions
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
CERVICAL INCOMPETENCE
Pregnancy, puerperium and perinatal conditions
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ECTOPIC PREGNANCY
Pregnancy, puerperium and perinatal conditions
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
PANIC ATTACK
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
SUICIDAL IDEATION
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
SUICIDE ATTEMPT
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ENDOMETRIOSIS
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
HEAVY MENSTRUAL BLEEDING
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
OVARIAN CYST RUPTURED
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ABORTION INDUCED
Surgical and medical procedures
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
THROMBOSIS
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
NAUSEA
Gastrointestinal disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG00312 events12 affected194 at risk
EG00419 events16 affected98 at risk
EG00555 events51 affected389 at risk
EG00611 events9 affected106 at risk
EG0073 events2 affected59 at risk
EG00813 events12 affected215 at risk
EG0090 events0 affected194 at risk
EG0100 events0 affected98 at risk
EG0111 events1 affected389 at risk
FATIGUE
General disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
COVID-19
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
BONE DENSITY DECREASED
Investigations
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
VITAMIN D DEFICIENCY
Metabolism and nutrition disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0021 events1 affected389 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0001 events1 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
MOOD SWINGS
Psychiatric disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
INTERMENSTRUAL BLEEDING
Reproductive system and breast disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA 26.1
Systematic Assessment
EG0000 events0 affected194 at risk
EG0010 events0 affected98 at risk
EG0020 events0 affected389 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D008599
Menstruation Disturbances
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D017699
Pelvic Pain
D010146
Pain
D009461
Neurologic Manifestations
D012816
Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C418365
estradiol, norethindrone drug combination
C539351
elagolix
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
14 subjects
FG0012 subjects
FG00214 subjects
Lost to Follow-up
FG0002 subjects
FG0013 subjects
FG0029 subjects
Requires surgery or invasive intervention for treatment of endometriosis
FG0002 subjects
FG0010 subjects
FG0021 subjects
Non-compliance with study procedures
FG0000 subjects
FG0012 subjects
FG0024 subjects
Pregnancy
FG0005 subjects
FG0010 subjects
FG0020 subjects
Other
FG00010 subjects
FG0013 subjects
FG00217 subjects
12 subjects
FG0015 subjects
FG00224 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0028 subjects
Requires surgery or invasive intervention for treatment of endometriosis
FG0000 subjects
FG0010 subjects
FG0022 subjects
Non-compliance with study procedures
FG0001 subjects
FG0011 subjects
FG0022 subjects
Exclusionary medications
FG0000 subjects
FG0010 subjects
FG0021 subjects
Other
FG0001 subjects
FG0011 subjects
FG0026 subjects
18 subjects
FG00111 subjects
FG00255 subjects
Lost to Follow-up
FG00028 subjects
FG00115 subjects
FG00250 subjects
Requires surgery or invasive intervention for treatment of endometriosis
FG0003 subjects
FG0011 subjects
FG0022 subjects
Non-compliance with study procedures
FG0004 subjects
FG0011 subjects
FG0026 subjects
Pregnancy
FG0007 subjects
FG0010 subjects
FG00218 subjects
Exclusionary medications
FG0001 subjects
FG0011 subjects
FG0025 subjects
COVID-19 logistical restrictions
FG0001 subjects
FG0010 subjects
FG0020 subjects
Other
FG00014 subjects
FG00110 subjects
FG00231 subjects
32.5
± 6.69
389
BG003679
58
BG003106
Not Hispanic or Latino
BG000156
BG00186
BG002331
BG003573
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
1
BG0032
Asian
BG0000
BG0010
BG0024
BG0034
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0021
BG0031
Black or African American
BG00031
BG00119
BG00249
BG00399
White
BG000159
BG00174
BG002328
BG003561
More than one race
BG0002
BG0014
BG0026
BG00312
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
OG00162.8(57.93 to 67.60)
Month 12
ParticipantsOG000189
ParticipantsOG001376
Title
Measurements
OG00029.1(22.62 to 35.58)
OG00163.8(58.97 to 68.69)
Month 12
Regression, Logistic
< 0.001
P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
4.33
2-Sided
95
2.968
6.331
Superiority
Elagolix + E2/NETA
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Units
Counts
Participants
OG000190
OG001384
Title
Denominators
Categories
Month 6
ParticipantsOG000190
ParticipantsOG001384
Title
Measurements
OG00036.8(29.98 to 43.70)
OG00151.3(46.30 to 56.30)
Month 12
ParticipantsOG000189
ParticipantsOG001376
Title
Measurements
OG00042.3(35.28 to 49.37)
OG001
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 6
Regression, Logistic
< 0.001
P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
1.82
2-Sided
95
1.275
2.605
Superiority
OG000
OG001
Month 12
Regression, Logistic
0.007
P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
1.63
2-Sided
95
1.146
2.326
Superiority
Units
Counts
Participants
OG000111
OG001216
Title
Denominators
Categories
Title
Measurements
OG000-0.73± 0.077
OG001-1.73± 0.055
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
mixed model repeated measures (MMRM)
< 0.001
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
Least Squares (LS) Mean of Difference
-0.99
Standard Error of the Mean
0.094
2-Sided
95
-1.180
-0.809
Superiority
Units
Counts
Participants
OG000138
OG001286
Title
Denominators
Categories
Title
Measurements
OG000-0.62± 0.072
OG001-1.64± 0.050
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
< 0.001
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-1.02
Standard Error of the Mean
0.088
2-Sided
95
-1.190
-0.845
Superiority
Units
Counts
Participants
OG000170
OG001335
Title
Denominators
Categories
Title
Measurements
OG000-0.56± 0.069
OG001-1.54± 0.049
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
< 0.001
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-0.99
Standard Error of the Mean
0.085
2-Sided
95
-1.156
-0.823
Superiority
Units
Counts
Participants
OG000111
OG001216
Title
Denominators
Categories
Title
Measurements
OG000-0.64± 0.060
OG001-0.86± 0.042
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
0.002
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-0.22
Standard Error of the Mean
0.073
2-Sided
95
-0.367
-0.080
Superiority
Units
Counts
Participants
OG000138
OG001286
Title
Denominators
Categories
Title
Measurements
OG000-0.57± 0.051
OG001-0.78± 0.036
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
< 0.001
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-0.21
Standard Error of the Mean
0.062
2-Sided
95
-0.329
-0.085
Superiority
Units
Counts
Participants
OG000170
OG001335
Title
Denominators
Categories
Title
Measurements
OG000-0.49± 0.046
OG001-0.65± 0.032
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
0.004
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-0.16
Standard Error of the Mean
0.056
2-Sided
95
-0.270
-0.050
Superiority
Units
Counts
Participants
OG000146
OG001302
Title
Denominators
Categories
Title
Measurements
OG000-4.71± 0.739
OG001-7.22± 0.514
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
ANCOVA
0.005
P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.
LS Mean of Difference
-2.51
Standard Error of the Mean
0.900
2-Sided
95
-4.283
-0.746
Superiority
Units
Counts
Participants
OG00084
OG001147
Title
Denominators
Categories
Title
Measurements
OG000-0.60± 0.079
OG001-0.70± 0.058
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
0.284
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-0.11
Standard Error of the Mean
0.098
2-Sided
95
-0.298
0.088
Superiority
Units
Counts
Participants
OG00096
OG001209
Title
Denominators
Categories
Title
Measurements
OG000-0.54± 0.076
OG001-0.63± 0.053
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
0.286
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-0.10
Standard Error of the Mean
0.092
2-Sided
95
-0.279
0.083
Superiority
Units
Counts
Participants
OG000119
OG001257
Title
Denominators
Categories
Title
Measurements
OG000-0.40± 0.064
OG001-0.62± 0.045
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
0.005
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-0.22
Standard Error of the Mean
0.079
2-Sided
95
-0.375
-0.066
Superiority
Units
Counts
Participants
OG000108
OG001220
Title
Denominators
Categories
Title
Measurements
OG000-6.43± 0.949
OG001-8.92± 0.665
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
ANCOVA
0.032
P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.
LS Mean of Difference
-2.49
Standard Error of the Mean
1.158
2-Sided
95
-4.773
-0.216
Superiority
Units
Counts
Participants
OG000102
OG001202
Title
Denominators
Categories
Title
Measurements
OG000-3.25± 0.263
OG001-4.39± 0.186
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
< 0.001
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-1.14
Standard Error of the Mean
0.322
2-Sided
95
-1.774
-0.508
Superiority
Units
Counts
Participants
OG000130
OG001269
Title
Denominators
Categories
Title
Measurements
OG000-2.74± 0.248
OG001-4.12± 0.174
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
< 0.001
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.
LS Mean of Difference
-1.38
Standard Error of the Mean
0.303
2-Sided
95
-1.978
-0.788
Superiority
Units
Counts
Participants
OG000156
OG001304
Title
Denominators
Categories
Title
Measurements
OG000-2.33± 0.225
OG001-3.79± 0.161
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented.
MMRM
< 0.001
P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant.