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A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-I)

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: NCT01620528
Recruitment Status : Completed
First Posted : June 15, 2012
Results First Posted : September 18, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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 Drug: elagolix
Other: placebo
Enrollment 872
Recruitment Details After completing the Treatment Period, participants (who were eligible and provided consent) entered a separate continuous-use extension study (Study M12-667, NCT01760954).
Pre-assignment Details Participants who prematurely discontinued from study drug and those who declined to participate in or who did not qualify for the continuous-use extension study, except for those who became pregnant, could elect to enter the Post-Treatment Follow-Up (PTFU) Period within this study for up to 12 additional months.
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 374 249 249 [1]
Completed 274 196 183
Not Completed 100 53 66
Reason Not Completed
Did Not Receive Study Drug             0             0             1
Withdrawal by Subject             35             21             16
Adverse Event             17             13             21
Lost to Follow-up             16             8             14
Not Specified             9             5             7
Subject Noncompliant             11             2             2
Pregnancy             7             2             2
Surgery/Invasive Intervention             5             1             3
Exclusionary Medication Received             0             1             0
[1]
1 subject did not receive study drug
Period Title: Post-Treatment Follow-Up Period
Started 68 [1] 48 [1] 51 [1]
Completed PTFU Month 6 [2] 46 26 [3] 18 [3]
Completed PTFU Month 12 2 5 19
Completed 48 31 37
Not Completed 20 17 14
Reason Not Completed
Withdrawal by Subject             3             7             3
Lost to Follow-up             3             2             4
Exclusionary Medication Received             0             1             1
Surgery/Invasive Intervention             8             3             4
Not Specified             6             4             2
[1]
elected to enter the PTFU Period
[2]
Met criteria (reported post-treatment menses, met the DXA criteria, and had a PTFU Month 6 visit).
[3]
Met criteria (reported a post-treatment menses, met the DXA criteria, and had a PTFU Month 6 visit).
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 374 249 248 871
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 374 participants 249 participants 248 participants 871 participants
31.7  (6.35) 31.5  (5.99) 31.2  (6.33) 31.5  (6.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 374 participants 249 participants 248 participants 871 participants
Female
374
 100.0%
249
 100.0%
248
 100.0%
871
 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). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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 373 248 244
Measure Type: Number
Unit of Measure: percentage of participants
19.6 46.4 75.8
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 < 0.001
Comments [Not Specified]
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 [Not Specified]
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). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
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 373 248 244
Measure Type: Number
Unit of Measure: percentage of participants
36.5 50.4 54.5
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 [Not Specified]
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 [Not Specified]
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 329 226 213
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.09  (0.098) -1.74  (0.120) -2.39  (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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.155
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -1.30
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 288 198 182
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.44  (0.047) -0.89  (0.057) -1.75  (0.059)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.45
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value -1.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.076
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 288 198 182
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.31  (0.035) -0.48  (0.043) -0.72  (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 0.004
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.16
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.057
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 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 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 329 226 213
Least Squares Mean (Standard Error)
Unit of Measure: pills
-0.29  (0.032) -0.29  (0.039) -0.55  (0.040)
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 0.910
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.051
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.051
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 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 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 288 198 182
Least Squares Mean (Standard Error)
Unit of Measure: pills
-0.27  (0.036) -0.35  (0.043) -0.56  (0.045)
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 0.185
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.07
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 5 of 7.
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 Least Squares Mean Difference
Estimated Value -0.28
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.057
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 246 171 153
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.29  (0.041) -0.39  (0.050) -0.49  (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 0.144
Comments [Not Specified]
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: 0.065
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 0.003
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.20
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 rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 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 329 226 213
Least Squares Mean (Standard Error)
Unit of Measure: pills
-0.10  (0.024) -0.07  (0.029) -0.22  (0.029)
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 0.424
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.037
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 0.002
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Mean Change
Estimated Value -0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.038
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Responders at Month 1 Based on Daily Assessment of DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 1 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.
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 372 248 245
Measure Type: Number
Unit of Measure: percentage of participants
14.5 35.1 44.1
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 [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Responders at Month 2 Based on Daily Assessment of DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 2 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.
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 373 248 244
Measure Type: Number
Unit of Measure: percentage of participants
17.2 44.8 71.3
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 [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Responders at Month 4 Based on Daily Assessment of DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 4 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.
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 373 248 243
Measure Type: Number
Unit of Measure: percentage of participants
21.7 47.6 75.3
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 [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
13.Secondary Outcome
Title Percentage of Responders at Month 5 Based on Daily Assessment of DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 5 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..
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 371 247 243
Measure Type: Number
Unit of Measure: percentage of participants
24.3 45.7 79.0
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 [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Responders at Month 6 Based on Daily Assessment of DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 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.
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 372 247 243
Measure Type: Number
Unit of Measure: percentage of participants
23.1 42.1 75.3
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 [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Responders at Month 1 Based on Daily Assessment of NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 1 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.
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 372 248 245
Measure Type: Number
Unit of Measure: percentage of participants
25.8 32.3 33.9
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 0.103
Comments [Not Specified]
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 0.023
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Responders at Month 2 Based on Daily Assessment of NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 2 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.
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 373 248 244
Measure Type: Number
Unit of Measure: percentage of participants
32.2 41.1 46.3
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 0.031
Comments [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Responders at Month 4 Based on Daily Assessment of NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 4 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.
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 373 248 243
Measure Type: Number
Unit of Measure: percentage of participants
35.4 53.2 63.8
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 < 0.001
Comments [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Responders at Month 5 Based on Daily Assessment of NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 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. 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 371 247 243
Measure Type: Number
Unit of Measure: percentage of participants
38.3 49.8 62.1
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 0.005
Comments [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Responders at Month 6 Based on Daily Assessment of NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At 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. 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 372 247 243
Measure Type: Number
Unit of Measure: percentage of participants
34.9 45.7 62.1
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 0.008
Comments [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Responders at Month 1 for DYSP
Hide Description The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 1 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.
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 293 191 176
Measure Type: Number
Unit of Measure: percentage of participants
26.3 30.4 31.8
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 0.306
Comments [Not Specified]
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 0.239
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Responders at Month 2 for DYSP
Hide Description The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 2 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.
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 287 190 179
Measure Type: Number
Unit of Measure: percentage of participants
33.1 33.7 44.7
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 0.855
Comments [Not Specified]
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 0.012
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Responders at Month 4 for DYSP
Hide Description The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 4 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.
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 278 185 168
Measure Type: Number
Unit of Measure: percentage of participants
33.1 44.3 54.2
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 0.010
Comments [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Responders at Month 5 for DYSP
Hide Description The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 5 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.
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 275 183 166
Measure Type: Number
Unit of Measure: percentage of participants
35.3 43.7 54.8
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 0.061
Comments [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Responders at Month 6 for DYSP
Hide Description The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Time Frame At Month 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.
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 270 187 161
Measure Type: Number
Unit of Measure: percentage of participants
33.3 39.6 50.3
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 0.126
Comments [Not Specified]
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 [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline to Month 1 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 1 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 372 248 245
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.33  (0.044) -0.83  (0.054) -0.98  (0.054)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.50
Confidence Interval (2-Sided) 97.5%
-0.65 to -0.34
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.070
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.65
Confidence Interval (2-Sided) 97.5%
-0.81 to -0.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.070
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline to Month 2 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 2 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 348 232 221
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.32  (0.042) -0.96  (0.052) -1.68  (0.053)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.64
Confidence Interval (2-Sided) 97.5%
-0.79 to -0.49
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 [Not Specified]
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 -1.36
Confidence Interval (2-Sided) 97.5%
-1.51 to -1.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.068
Estimation Comments [Not Specified]
27.Secondary Outcome
Title Change From Baseline to Month 3 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) 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.
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 329 226 213
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.35  (0.043) -1.03  (0.052) -1.73  (0.054)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.68
Confidence Interval (2-Sided) 97.5%
-0.83 to -0.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.068
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -1.39
Confidence Interval (2-Sided) 97.5%
-1.54 to -1.23
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.069
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline to Month 4 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 4 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 316 219 198
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.40  (0.045) -1.05  (0.054) -1.72  (0.057)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.65
Confidence Interval (2-Sided) 97.5%
-0.81 to -0.49
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 [Not Specified]
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 -1.32
Confidence Interval (2-Sided) 97.5%
-1.49 to -1.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.072
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline to Month 5 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 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.
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 299 202 191
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.43  (0.045) -1.02  (0.054) -1.84  (0.056)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.59
Confidence Interval (2-Sided) 97.5%
-0.75 to -0.43
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 [Not Specified]
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 -1.41
Confidence Interval (2-Sided) 97.5%
-1.58 to -1.25
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.072
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Percent Change From Baseline to Month 1 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 1 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 372 248 245
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-14.35  (2.079) -38.42  (2.547) -45.35  (2.562)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -24.07
Confidence Interval (2-Sided) 97.5%
-31.45 to -16.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.288
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -31.01
Confidence Interval (2-Sided) 97.5%
-38.41 to -23.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.299
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Percent Change From Baseline to Month 2 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 2 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 348 232 221
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-13.44  (1.965) -44.23  (2.407) -77.22  (2.460)
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 -30.79
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -30.79
Confidence Interval (2-Sided) 97.5%
-37.77 to -23.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.107
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -63.78
Confidence Interval (2-Sided) 97.5%
-70.85 to -56.71
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.148
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Percent Change From Baseline to Month 3 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) 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.
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 329 226 213
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-14.80  (2.022) -47.01  (2.451) -79.74  (2.519)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -32.21
Confidence Interval (2-Sided) 97.5%
-39.35 to -25.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.177
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -64.94
Confidence Interval (2-Sided) 97.5%
-72.19 to -57.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.230
Estimation Comments [Not Specified]
33.Secondary Outcome
Title Percent Change From Baseline to Month 4 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 4 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 316 219 198
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-18.08  (2.088) -48.02  (2.519) -79.98  (2.627)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -29.94
Confidence Interval (2-Sided) 97.5%
-37.28 to -22.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.272
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -61.90
Confidence Interval (2-Sided) 97.5%
-69.44 to -54.36
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.356
Estimation Comments [Not Specified]
34.Secondary Outcome
Title Percent Change From Baseline to Month 5 in Mean Pain Score for DYS
Hide Description The DYS pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 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.
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 299 202 191
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-18.09  (2.072) -46.72  (2.517) -84.58  (2.595)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -28.63
Confidence Interval (2-Sided) 97.5%
-35.96 to -21.31
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.260
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -66.50
Confidence Interval (2-Sided) 97.5%
-73.95 to -59.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.321
Estimation Comments [Not Specified]
35.Secondary Outcome
Title Percent Change From Baseline to Month 6 in Mean Pain Score for 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 288 198 182
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-19.21  (2.217) -40.60  (2.681) -79.99  (2.782)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -21.39
Confidence Interval (2-Sided) 97.5%
-29.20 to -13.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.479
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -60.78
Confidence Interval (2-Sided) 97.5%
-68.77 to -52.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.557
Estimation Comments [Not Specified]
36.Secondary Outcome
Title Change From Baseline to Month 1 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 1 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 372 248 245
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.16  (0.023) -0.22  (0.028) -0.26  (0.028)
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 0.111
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%
-0.14 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.036
Estimation 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 0.008
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%
-0.18 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.036
Estimation Comments [Not Specified]
37.Secondary Outcome
Title Change From Baseline to Month 2 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 2 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 348 232 221
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.26  (0.028) -0.33  (0.035) -0.44  (0.035)
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 0.092
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.08
Confidence Interval (2-Sided) 97.5%
-0.18 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 97.5%
-0.28 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments [Not Specified]
38.Secondary Outcome
Title Change From Baseline to Month 3 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) 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
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 329 226 213
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.32  (0.032) -0.44  (0.039) -0.61  (0.039)
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 0.017
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.12
Confidence Interval (2-Sided) 97.5%
-0.23 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.050
Estimation 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 [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: 0.050
Estimation Comments [Not Specified]
39.Secondary Outcome
Title Change From Baseline to Month 4 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 4 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 316 219 198
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.33  (0.034) -0.51  (0.041) -0.72  (0.042)
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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 97.5%
-0.31 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.053
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 97.5%
-0.51 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.054
Estimation Comments [Not Specified]
40.Secondary Outcome
Title Change From Baseline to Month 5 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 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
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 299 202 191
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.34  (0.034) -0.49  (0.041) -0.74  (0.042)
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 0.004
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 97.5%
-0.27 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.053
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 97.5%
-0.52 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.054
Estimation Comments [Not Specified]
41.Secondary Outcome
Title Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 1 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 372 248 245
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-7.51  (1.736) -13.74  (2.131) -15.23  (2.139)
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 0.024
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -6.23
Confidence Interval (2-Sided) 97.5%
-12.40 to -0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.748
Estimation 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 0.005
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -7.72
Confidence Interval (2-Sided) 97.5%
-13.90 to -1.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.756
Estimation Comments [Not Specified]
42.Secondary Outcome
Title Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 2 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 348 232 221
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-13.81  (2.039) -19.50  (2.501) -27.53  (2.529)
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 0.078
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -5.69
Confidence Interval (2-Sided) 97.5%
-12.93 to 1.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.226
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -13.72
Confidence Interval (2-Sided) 97.5%
-21.01 to -6.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.249
Estimation Comments [Not Specified]
43.Secondary Outcome
Title Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) 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.
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 329 226 213
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-17.64  (2.204) -26.10  (2.688) -40.13  (2.737)
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 0.015
Comments [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -8.47
Confidence Interval (2-Sided) 97.5%
-16.27 to -0.66
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.475
Estimation 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 [Not Specified]
Method mixed-effects model
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -22.49
Confidence Interval (2-Sided) 97.5%
-30.38 to -14.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.514
Estimation Comments [Not Specified]
44.Secondary Outcome
Title Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP
Hide Description The NMPP pain scale ranges from 0 (none) to 3 (severe).
Time Frame Baseline, Month 4 of Treatment Period