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A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01931670
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Endometriosis
Interventions Other: placebo
Drug: Elagolix
Enrollment 815
Recruitment Details Participants were randomized at 187 sites in Argentina, Austria, Australia, Brazil, Czech Republic, Hungary, Italy, New Zealand, Poland, South Africa, Spain, the United States, and the United Kingdom.
Pre-assignment Details The study consisted of 4 periods: a Washout Period (if applicable); a Screening Period of ≤ 100 days prior to first dose; a 6-month Treatment Period; and a Post-Treatment Follow-up Period of ≤ 12 months (if applicable). Participants were randomized into the study in a 3:2:2 ratio to placebo, elagolix 150 mg QD, or elagolix 200 mg BID, respectively.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description Placebo twice daily (BID) for the 6-month Treatment Period Elagolix 150 mg once daily (QD) for the 6-month Treatment Period Elagolix 200 mg BID for the 6-month Treatment Period
Period Title: Treatment Period
Started 360 226 229
Completed 270 178 184
Not Completed 90 48 45
Reason Not Completed
Exclusionary Medication Received             1             1             1
Surgery/Invasive Intervention             4             2             0
Subject Noncompliant             4             9             5
Adverse Event             19             8             21
Lack of Efficacy             11             2             2
Pregnancy             7             2             0
Not Specified             8             7             2
Consent Withdrawn by Subject             17             12             7
Lost to Follow-up             19             5             7
Period Title: Post-Treatment Follow-Up (PTFU) Period
Started [1] 61 40 54
Completed PTFU Month 6 42 24 18
Completed PTFU Month 12 0 4 15
Completed 42 28 33
Not Completed 19 12 21
Reason Not Completed
Exclusionary Medication Received             3             0             0
Adverse Event             0             2             1
Surgery/Invasive Intervention             4             4             2
Not Specified             6             3             3
Consent Withdrawn by Subject             6             3             13
Lost to Follow-up             0             0             2
[1]
Participants who elected to enter the PTFU Period in this study for up to an additional 12 months.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID Total
Hide Arm/Group Description Placebo BID for the 6-month Treatment Period Elagolix 150 mg QD for the 6-month Treatment Period Elagolix 200 mg BID for the 6-month Treatment Period Total of all reporting groups
Overall Number of Baseline Participants 360 226 229 815
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 360 participants 226 participants 229 participants 815 participants
33.1  (6.69) 33.1  (6.80) 33.4  (6.67) 33.2  (6.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 360 participants 226 participants 229 participants 815 participants
Female
360
 100.0%
226
 100.0%
229
 100.0%
815
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of –0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame At Month 3 of the Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The modified intent-to-treat (mITT) analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 353 221 225
Measure Type: Number
Unit of Measure: percentage of participants
22.7 43.4 72.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.
Method Regression, Logistic
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of –0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame At Month 3 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 353 221 225
Measure Type: Number
Unit of Measure: percentage of participants
36.5 49.8 57.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments An elagolix dose group was to be considered more efficacious than placebo for the co-primary endpoints if and only if both co-primary endpoints (DYS and NMPP) were statistically significant for the elagolix dose group at the 0.025 significance level.
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores
Hide Description The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Time Frame Baseline, Month 3 of the Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 312 204 209
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.33  (0.097) -1.90  (0.122) -2.55  (0.122)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Ranked secondary efficacy endpoint 1 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.156
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Ranked secondary efficacy endpoint 1 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -1.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.156
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Month 6 in DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 6 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 273 185 187
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.52  (0.047) -1.06  (0.057) -1.65  (0.057)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Ranked secondary efficacy endpoint 2 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.074
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Ranked secondary efficacy endpoint 2 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -1.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.074
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to Month 6 in NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 6 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 273 185 187
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.48  (0.035) -0.63  (0.044) -0.80  (0.044)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Ranked secondary efficacy endpoint 3 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.056
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Ranked secondary efficacy endpoint 3 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.056
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics
Hide Description Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time Frame Baseline, Month 3 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 312 204 209
Least Squares Mean (Standard Error)
Unit of Measure: number of pills
-0.31  (0.028) -0.36  (0.035) -0.49  (0.034)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Ranked secondary efficacy endpoint 4 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.044
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Ranked secondary efficacy endpoint 4 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.044
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics
Hide Description Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time Frame Baseline, Month 6 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 273 185 187
Least Squares Mean (Standard Error)
Unit of Measure: number of pills
-0.32  (0.030) -0.40  (0.038) -0.52  (0.037)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Ranked secondary efficacy endpoint 5 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.048
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Ranked secondary efficacy endpoint 5 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.048
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to Month 3 in Dyspareunia (DYSP)
Hide Description The DYSP pain scale ranges from 0 (absent) to 3 (severe).
Time Frame Baseline, Month 3 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 226 145 150
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.30  (0.042) -0.39  (0.052) -0.60  (0.052)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Ranked secondary efficacy endpoint 6 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.172
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.067
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Ranked secondary efficacy endpoint 6 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.067
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)
Hide Description Permitted country-specific rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen. Assessment was based on average pill counts.
Time Frame Baseline, Month 3 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 312 204 209
Least Squares Mean (Standard Error)
Unit of Measure: number of pills
-0.12  (0.019) -0.12  (0.024) -0.21  (0.023)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Ranked secondary efficacy endpoint 7 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.968
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.030
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Ranked secondary efficacy endpoint 7 of 7.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments For an elagolix dose group to be considered statistically significantly better than placebo on a secondary endpoint, the P value must have been ≤ 0.025 for that endpoint, for all higher-ranking secondary endpoints, and for the co-primary endpoints.
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.030
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Responders for Each Month, Except Month 3, in DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.85 or greater from Baseline in DYS pain as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame Months 1, 2, 4, 5, 6 of the Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 358 221 225
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 358 participants 221 participants 225 participants
17.3 33.0 46.2
Month 2 Number Analyzed 358 participants 221 participants 225 participants
19.0 39.4 69.8
Month 4 Number Analyzed 354 participants 220 participants 223 participants
21.2 45.9 79.8
Month 5 Number Analyzed 354 participants 220 participants 223 participants
23.7 44.1 80.7
Month 6 Number Analyzed 355 participants 221 participants 225 participants
25.4 46.2 76.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.361
Confidence Interval (2-Sided) 97.5%
1.507 to 3.697
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.185
Confidence Interval (2-Sided) 97.5%
2.707 to 6.469
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.795
Confidence Interval (2-Sided) 97.5%
1.811 to 4.312
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 10.378
Confidence Interval (2-Sided) 97.5%
6.615 to 16.282
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.178
Confidence Interval (2-Sided) 97.5%
2.084 to 4.845
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 15.216
Confidence Interval (2-Sided) 97.5%
9.429 to 24.554
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.548
Confidence Interval (2-Sided) 97.5%
1.683 to 3.859
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 14.055
Confidence Interval (2-Sided) 97.5%
8.716 to 22.664
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.536
Confidence Interval (2-Sided) 97.5%
1.685 to 3.816
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 10.106
Confidence Interval (2-Sided) 97.5%
6.434 to 15.874
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Responders for Each Month, Except Month 3, in NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of -0.43 or greater from Baseline in NMPP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame Months 1, 2, 4, 5, 6 of the Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 358 221 225
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 23.5 27.6 29.3
Month 2 32.1 39.8 50.7
Month 4 38.7 51.4 63.2
Month 5 39.8 50.5 63.2
Month 6 40.6 51.6 62.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.376
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.191
Confidence Interval (2-Sided) 97.5%
0.765 to 1.855
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.376
Confidence Interval (2-Sided) 97.5%
0.890 to 2.127
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.088
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.358
Confidence Interval (2-Sided) 97.5%
0.909 to 2.029
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.208
Confidence Interval (2-Sided) 97.5%
1.488 to 3.278
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.678
Confidence Interval (2-Sided) 97.5%
1.136 to 2.477
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.722
Confidence Interval (2-Sided) 97.5%
1.832 to 4.044
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.537
Confidence Interval (2-Sided) 97.5%
1.042 to 2.267
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.598
Confidence Interval (2-Sided) 97.5%
1.750 to 3.857
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.565
Confidence Interval (2-Sided) 97.5%
1.062 to 2.306
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.412
Confidence Interval (2-Sided) 97.5%
1.630 to 3.570
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Responders at Each Month for DYSP
Hide Description The DYSP pain scale ranged from 0 (absent) to 3 (severe) as recorded in a daily electronic diary. The criteria for defining a participant as a responder included a reduction of –0.29 or greater from Baseline in DYSP as well as no increased rescue analgesic use for endometriosis-associated pain.
Time Frame Months 1, 2, 3, 4, 5, 6 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. Participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 262 168 171
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 261 participants 160 participants 171 participants
33.3 33.8 35.1
Month 2 Number Analyzed 262 participants 168 participants 171 participants
33.2 39.9 47.4
Month 3 Number Analyzed 256 participants 159 participants 162 participants
39.5 44.0 53.7
Month 4 Number Analyzed 257 participants 160 participants 164 participants
38.5 41.3 59.8
Month 5 Number Analyzed 254 participants 159 participants 155 participants
37.4 42.8 58.1
Month 6 Number Analyzed 254 participants 163 participants 165 participants
39.4 39.9 55.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.901
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.028
Confidence Interval (2-Sided) 97.5%
0.624 to 1.693
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.65
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.103
Confidence Interval (2-Sided) 97.5%
0.680 to 1.789
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.154
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.351
Confidence Interval (2-Sided) 97.5%
0.841 to 2.170
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.871
Confidence Interval (2-Sided) 97.5%
1.175 to 2.979
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.294
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.250
Confidence Interval (2-Sided) 97.5%
0.776 to 2.013
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.865
Confidence Interval (2-Sided) 97.5%
1.163 to 2.989
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.521
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.145
Confidence Interval (2-Sided) 97.5%
0.713 to 1.839
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.474
Confidence Interval (2-Sided) 97.5%
1.544 to 3.963
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.262
Confidence Interval (2-Sided) 97.5%
0.787 to 2.023
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.416
Confidence Interval (2-Sided) 97.5%
1.500 to 3.891
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.953
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.013
Confidence Interval (2-Sided) 97.5%
0.631 to 1.624
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.997
Confidence Interval (2-Sided) 97.5%
1.253 to 3.183
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline (Prior to administering study drug), Months 1, 2, 3, 4, 5 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 358 221 225
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 358 participants 221 participants 225 participants
-0.33  (0.044) -0.86  (0.056) -1.11  (0.056)
Month 2 Number Analyzed 337 participants 213 participants 212 participants
-0.39  (0.042) -0.84  (0.053) -1.67  (0.053)
Month 3 Number Analyzed 312 participants 204 participants 209 participants
-0.45  (0.042) -0.97  (0.053) -1.70  (0.052)
Month 4 Number Analyzed 294 participants 198 participants 198 participants
-0.47  (0.044) -1.05  (0.054) -1.74  (0.054)
Month 5 Number Analyzed 281 participants 189 participants 193 participants
-0.50  (0.045) -0.99  (0.055) -1.76  (0.055)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.53
Confidence Interval (2-Sided) 97.5%
-0.69 to -0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.78
Confidence Interval (2-Sided) 97.5%
-0.94 to -0.62
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.44
Confidence Interval (2-Sided) 97.5%
-0.6 to -0.29
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.068
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -1.27
Confidence Interval (2-Sided) 97.5%
-1.43 to -1.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.068
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.53
Confidence Interval (2-Sided) 97.5%
-0.68 to -0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.068
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -1.25
Confidence Interval (2-Sided) 97.5%
-1.4 to -1.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.067
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.58
Confidence Interval (2-Sided) 97.5%
-0.73 to -0.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -1.27
Confidence Interval (2-Sided) 97.5%
-1.42 to -1.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.07
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.49
Confidence Interval (2-Sided) 97.5%
-0.65 to -0.33
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -1.26
Confidence Interval (2-Sided) 97.5%
-1.42 to -1.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.071
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percent Change From Baseline to Each Month in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 358 221 224
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
Month 1 Number Analyzed 358 participants 221 participants 224 participants
-14.36  (2.268) -39.67  (2.886) -53.68  (2.867)
Month 2 Number Analyzed 337 participants 213 participants 211 participants
-17.36  (2.087) -39.26  (2.629) -80.68  (2.638)
Month 3 Number Analyzed 312 participants 204 participants 208 participants
-20.58  (2.031) -45.73  (2.528) -82.52  (2.513)
Month 4 Number Analyzed 294 participants 198 participants 198 participants
-21.55  (2.104) -48.52  (2.601) -83.92  (2.599)
Month 5 Number Analyzed 281 participants 189 participants 193 participants
-22.63  (2.159) -45.99  (2.664) -85.53  (2.650)
Month 6 Number Analyzed 273 participants 185 participants 187 participants
-23.81  (2.225) -49.70  (2.738) -80.43  (2.727)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -25.31
Confidence Interval (2-Sided) 97.5%
-33.55 to -17.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.669
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -39.32
Confidence Interval (2-Sided) 97.5%
-47.53 to -31.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.657
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -21.9
Confidence Interval (2-Sided) 97.5%
-29.44 to -14.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.355
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -63.31
Confidence Interval (2-Sided) 97.5%
-70.87 to -55.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.365
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -25.15
Confidence Interval (2-Sided) 97.5%
-32.43 to -17.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.241
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -61.94
Confidence Interval (2-Sided) 97.5%
-69.20 to -54.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.233
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -26.97
Confidence Interval (2-Sided) 97.5%
-34.48 to -19.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.344
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -62.37
Confidence Interval (2-Sided) 97.5%
-69.89 to -54.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.346
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -23.36
Confidence Interval (2-Sided) 97.5%
-31.06 to -15.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.428
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -62.9
Confidence Interval (2-Sided) 97.5%
-70.58 to -55.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.42
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -25.89
Confidence Interval (2-Sided) 97.5%
-33.81 to -17.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.528
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -56.62
Confidence Interval (2-Sided) 97.5%
-64.53 to -48.70
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.522
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline to Each Month, Except Month 6, in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Months 1, 2, 3, 4, 5 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 358 221 225
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 358 participants 221 participants 225 participants
-0.22  (0.025) -0.24  (0.031) -0.31  (0.031)
Month 2 Number Analyzed 337 participants 213 participants 212 participants
-0.34  (0.027) -0.41  (0.034) -0.54  (0.034)
Month 3 Number Analyzed 312 participants 204 participants 209 participants
-0.39  (0.031) -0.50  (0.039) -0.69  (0.039)
Month 4 Number Analyzed 294 participants 198 participants 198 participants
-0.45  (0.033) -0.54  (0.041) -0.78  (0.041)
Month 5 Number Analyzed 281 participants 189 participants 193 participants
-0.48  (0.034) -0.58  (0.042) -0.81  (0.042)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.549
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 97.5%
-0.11 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 97.5%
-0.18 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 97.5%
-0.17 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.044
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 97.5%
-0.30 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 97.5%
-0.22 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 97.5%
-0.41 to -0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 97.5%
-0.21 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.052
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.33
Confidence Interval (2-Sided) 97.5%
-0.45 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.052
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.10
Confidence Interval (2-Sided) 97.5%
-0.22 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.054
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.34
Confidence Interval (2-Sided) 97.5%
-0.46 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.054
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percent Change From Baseline to Each Month in the Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Months 1, 2, 3, 4, 5, 6 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 358 221 225
Least Squares Mean (Standard Deviation)
Unit of Measure: percentage change
Month 1 Number Analyzed 358 participants 221 participants 225 participants
-12.43  (1.814) -15.47  (2.313) -18.86  (2.288)
Month 2 Number Analyzed 337 participants 213 participants 212 participants
-21.13  (1.836) -26.30  (2.326) -34.32  (2.316)
Month 3 Number Analyzed 312 participants 204 participants 209 participants
-25.78  (2.104) -32.63  (2.643) -44.83  (2.625)
Month 4 Number Analyzed 294 participants 198 participants 198 participants
-29.94  (2.170) -36.19  (2.711) -51.52  (2.696)
Month 5 Number Analyzed 281 participants 189 participants 193 participants
-31.96  (2.214) -38.17  (2.756) -53.61  (2.737)
Month 6 Number Analyzed 273 participants 185 participants 187 participants
-31.25  (2.349) -42.09  (2.914) -52.42  (2.897)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.301
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -3.04
Confidence Interval (2-Sided) 97.5%
-9.64 to 3.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -6.43
Confidence Interval (2-Sided) 97.5%
-12.99 to 0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.92
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -5.17
Confidence Interval (2-Sided) 97.5%
-11.82 to 1.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.964
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -13.19
Confidence Interval (2-Sided) 97.5%
-19.83 to -6.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.956
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -6.84
Confidence Interval (2-Sided) 97.5%
-14.43 to 0.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.379
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -19.05
Confidence Interval (2-Sided) 97.5%
-26.61 to -11.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.364
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -6.25
Confidence Interval (2-Sided) 97.5%
-14.05 to 1.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.473
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -21.58
Confidence Interval (2-Sided) 97.5%
-29.35 to -13.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.46
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -6.21
Confidence Interval (2-Sided) 97.5%
-14.15 to 1.73
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.536
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -21.66
Confidence Interval (2-Sided) 97.5%
-29.56 to -13.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.52
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -10.83
Confidence Interval (2-Sided) 97.5%
-19.24 to -2.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.744
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -21.16
Confidence Interval (2-Sided) 97.5%
-29.54 to -12.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.729
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to Each Month, Except Month 3, in the Mean Pain Score of DYSP
Hide Description The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Time Frame Baseline, Months 1, 2, 4, 5, 6 of Treatment Period
Hide Outcome Measure Data
Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. Participants with an assessment at given timepoint.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
Hide Arm/Group Description:
Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 261 161 171
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 261 participants 160 participants 171 participants
-0.21  (0.037) -0.19  (0.046) -0.26  (0.045)
Month 2 Number Analyzed 247 participants 161 participants 162 participants
-0.25  (0.038) -0.32  (0.047) -0.49  (0.047)
Month 4 Number Analyzed 212 participants 143 participants 146 participants
-0.35  (0.045) -0.40  (0.055) -0.63  (0.055)
Month 5 Number Analyzed 196 participants 137 participants 133 participants
-0.39  (0.046) -0.41  (0.056) -0.70  (0.056)
Month 6 Number Analyzed 189 participants 137 participants 137 participants
-0.36  (0.049) -0.42  (0.058) -0.69  (0.058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value 0.02
Confidence Interval (2-Sided) 97.5%
-0.11 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.059
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.431
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 97.5%
-0.18 to 0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.058
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.07
Confidence Interval (2-Sided) 97.5%
-0.20 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.24
Confidence Interval (2-Sided) 97.5%
-0.37 to -0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.494
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.05
Confidence Interval (2-Sided) 97.5%
-0.21 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 4
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.27
Confidence Interval (2-Sided) 97.5%
-0.43 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.071
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.765
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.02
Confidence Interval (2-Sided) 97.5%
-0.18 to 0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.072
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 5
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.31
Confidence Interval (2-Sided) 97.5%
-0.47 to -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.073
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.468
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 97.5%
-0.23 to 0.12
Parameter Dispersion
Type: Standard Deviation
Value: 0.076
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 200 mg BID
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.33
Confidence Interval (2-Sided) 97.5%
-0.50 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.076
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline to Each Month, Except Months 3 and 6, in Analgesic Use Across Both Classes of Rescue Analgesics
Hide Description Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 or 550 mg), and one country-specific narcotic analgesic (5 mg hydrocodone + 300 or 325 mg acetaminophen, or 30 mg codeine + 500 mg acetaminophen, or 30 mg codeine, or 37.5 mg tramadol + 325 mg acetaminophen). Assessment was based on average pill counts.
Time Frame Baseline, Months 1, 2, 4, 5
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Hide Analysis Population Description
The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases.
Arm/Group Title Placebo Elagolix 150 mg QD Elagolix 200 mg BID
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Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD for the 6-month Treatment Period
Elagolix 200 mg BID for the 6-month Treatment Period
Overall Number of Participants Analyzed 358 221 225
Least Squares Mean (Standard Error)
Unit of Measure: number of pills
Month 1 Number Analyzed 358 participants 221 participants 225 participants
-0.20  (0.024) -0.29  (0.031) -0.32  (0.031)
Month 2 Number Analyzed 337 participants 213 participants 212 participants
-0.25  (0.026) -0.32  (0.033) -0.44  (0.033)
Month 4 Number Analyzed 294 participants 198 participants 198 participants
-0.29  (0.028) -0.38  (0.035) -0.51  (0.035)
Month 5 Number Analyzed 281 participants 189 participants 193 participants
-0.32  (0.030) -0.37  (0.038) -0.54  (0.038)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Month 1
Type of Statistical Test Superiority
Comments [Not Specified]