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A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

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: NCT03343067
Recruitment Status : Terminated (The study was terminated early for business reasons, not for safety concerns.)
First Posted : November 17, 2017
Results First Posted : November 27, 2019
Last Update Posted : November 27, 2019
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 Drug: elagolix
Drug: estradiol/norethindrone acetate (E2/NETA)
Enrollment 11
Recruitment Details  
Pre-assignment Details The study was terminated early for business reasons, not for safety concerns. There are no subject data past Treatment Month 6.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window

Period Title: Open Label Period: Day 1 to Month 3
Started 7 3 1
Completed 0 3 1
Not Completed 7 0 0
Period Title: Double Blind Period: Month 3 to Month 6
Started 0 3 1
Completed 0 0 0
Not Completed 0 3 1
Reason Not Completed
Study Terminated by Sponsor             0             3             1
Arm/Group Title Group A Group B Group C Total
Hide Arm/Group Description

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Total of all reporting groups
Overall Number of Baseline Participants 7 3 1 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
20 to < 25 years Number Analyzed 7 participants 3 participants 1 participants 11 participants
1
  14.3%
1
  33.3%
0
   0.0%
2
  18.2%
25 to < 30 years Number Analyzed 7 participants 3 participants 1 participants 11 participants
0
   0.0%
1
  33.3%
0
   0.0%
1
   9.1%
30 to < 35 years Number Analyzed 7 participants 3 participants 1 participants 11 participants
1
  14.3%
0
   0.0%
1
 100.0%
2
  18.2%
35 to < 40 years Number Analyzed 7 participants 3 participants 1 participants 11 participants
1
  14.3%
0
   0.0%
0
   0.0%
1
   9.1%
40 to < 45 years Number Analyzed 7 participants 3 participants 1 participants 11 participants
3
  42.9%
1
  33.3%
0
   0.0%
4
  36.4%
45 to < 50 years Number Analyzed 7 participants 3 participants 1 participants 11 participants
1
  14.3%
0
   0.0%
0
   0.0%
1
   9.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 1 participants 11 participants
Female
7
 100.0%
3
 100.0%
1
 100.0%
11
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 1 participants 11 participants
Hispanic or Latino
1
  14.3%
1
  33.3%
1
 100.0%
3
  27.3%
Not Hispanic or Latino
6
  85.7%
2
  66.7%
0
   0.0%
8
  72.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 3 participants 1 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  28.6%
1
  33.3%
0
   0.0%
3
  27.3%
White
5
  71.4%
1
  33.3%
0
   0.0%
6
  54.5%
More than one race
0
   0.0%
1
  33.3%
1
 100.0%
2
  18.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Dysmenorrhea (DYS) Pain Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 7 participants 3 participants 1 participants 11 participants
0.641  (0.1689) 0.429  (0.1030) 0.600 [2]   (NA) 0.579  (0.1696)
[1]
Measure Description: The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period.
[2]
1 participant analyzed
Non-Menstrual Pelvic Pain (NMPP) Pain Scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 7 participants 3 participants 1 participants 11 participants
1.053  (0.4534) 0.914  (0.4721) 2.400 [2]   (NA) 1.138  (0.5893)
[1]
Measure Description: The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period.
[2]
1 participant analyzed
Dyspareunia Pain Scale   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 7 participants 2 participants 1 participants 10 participants
0.539  (0.9064) 0.043  (0.0202) 3.000 [3]   (NA) 0.686  (1.1187)
[1]
Measure Description: The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period.
[2]
Measure Analysis Population Description: 1 subject did not complete assessment
[3]
1 participant analyzed
Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 7 participants 3 participants 1 participants 11 participants
5.176  (1.9302) 3.638  (1.5692) 7.371 [2]   (NA) 4.956  (1.9663)
[1]
Measure Description: The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period.
[2]
1 participant analyzed
Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids)   [1] 
Mean (Standard Deviation)
Unit of measure:  Pills/day
NSAID Number Analyzed 7 participants 3 participants 1 participants 11 participants
2.388  (2.7765) 0.581  (0.9330) 0.743 [2]   (NA) 1.745  (2.3655)
Opioid Number Analyzed 7 participants 3 participants 1 participants 11 participants
0.241  (0.3750) 0.057  (0.0990) 0.571 [2]   (NA) 0.221  (0.3270)
NSAID + Opioid Number Analyzed 7 participants 3 participants 1 participants 11 participants
2.629  (2.6903) 0.638  (0.8918) 1.314 [2]   (NA) 1.966  (2.3196)
[1]
Measure Description: Based on average pill counts and assessed using the daily e-Diary. Participants were allowed to take protocol-specified analgesic rescue medication for endometriosis-associated pain and recorded use daily in the e-Diary. A minimum of 45 days of daily e-Diary entries were required to be completed during the Screening Period. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.
[2]
1 participant analyzed
1.Primary Outcome
Title Proportion of Responders at Month 6 Based on DYS Pain Scale
Hide Description Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intended to be based on a receiver operating characteristic (ROC) threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Proportion of Responders at Month 6 Based on NMPP Pain Scale
Hide Description Proportion of responders at Month 6 based upon the scale for NMPP pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intended to be based on ROC threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change From Baseline in DYS at Month 6
Hide Description The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 1 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.23 [1]   (NA)
[1]
1 participant analyzed
4.Secondary Outcome
Title Change From Baseline in NMPP at Month 6
Hide Description The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 2 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
-0.13  (0.061)
5.Secondary Outcome
Title Change From Baseline in Dyspareunia at Month 6
Hide Description The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 1 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.29 [1]   (NA)
[1]
1 participant analyzed
6.Secondary Outcome
Title Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6
Hide Description The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 2 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.36  (0.020)
7.Secondary Outcome
Title Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6
Hide Description Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 2 0
Mean (Standard Deviation)
Unit of Measure: pills/day
NSAID: Change at Month 6 0.63  (0.606)
Opioid: Change at Month 6 0.09  (0.121)
NSAID + Opioid: Change at Month 6 0.71  (0.485)
8.Secondary Outcome
Title Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6
Hide Description The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with both baseline and post-baseline values for Daily Diary Endometriosis-Associated Pain Score via NRS.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 2 0
Measure Type: Number
Unit of Measure: percentage of participants
50.0
9.Secondary Outcome
Title Proportion of Responders Over Time
Hide Description As assessed by change and percent change from baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use)
Hide Description As assessed by change and percent change from Baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Change From Baseline Over Time in Monthly Average DYS Pain Score
Hide Description

The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

The analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis.

Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 6 2 0
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Month 1 Number Analyzed 6 participants 1 participants 0 participants
0.05  (0.655) -0.04 [1]   (NA)
Change at Month 2 Number Analyzed 4 participants 1 participants 0 participants
-0.18  (0.124) -0.26 [1]   (NA)
Change at Month 3 Number Analyzed 2 participants 1 participants 0 participants
-0.50  (0.263) -0.34 [1]   (NA)
Change at Month 4 Number Analyzed 1 participants 1 participants 0 participants
-0.69 [1]   (NA) -0.06 [1]   (NA)
Change at Month 5 Number Analyzed 0 participants 2 participants 0 participants
-0.16  (0.141)
Change at Month 6 Number Analyzed 0 participants 1 participants 0 participants
-0.23 [1]   (NA)
[1]
1 participant analyzed
12.Secondary Outcome
Title Change From Baseline Over Time in Monthly Average NMPP Pain Score
Hide Description The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 6 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Month 1 Number Analyzed 6 participants 3 participants 1 participants
-0.13  (0.252) -0.07  (0.508) 0.39 [1]   (NA)
Change at Month 2 Number Analyzed 5 participants 3 participants 1 participants
-0.48  (0.394) -0.30  (0.167) 0.29 [1]   (NA)
Change at Month 3 Number Analyzed 2 participants 3 participants 1 participants
-0.70  (0.828) -0.30  (0.092) 0.54 [1]   (NA)
Change at Month 4 Number Analyzed 1 participants 3 participants 1 participants
-1.34 [1]   (NA) -0.34  (0.029) 0.46 [1]   (NA)
Change at Month 5 Number Analyzed 0 participants 3 participants 0 participants
-0.27  (0.256)
Change at Month 6 Number Analyzed 0 participants 2 participants 0 participants
-0.13  (0.061)
[1]
1 participant analyzed
13.Secondary Outcome
Title Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score
Hide Description The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 4 2 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Month 1 Number Analyzed 4 participants 2 participants 1 participants
-0.50  (0.741) 0.30 [1]   (NA) -0.29 [1]   (NA)
Change at Month 2 Number Analyzed 2 participants 1 participants 1 participants
-1.44  (1.071) 0.06 [1]   (NA) -0.37 [1]   (NA)
Change at Month 3 Number Analyzed 1 participants 2 participants 1 participants
-2.20 [1]   (NA) 0.07  (0.101) -0.03 [1]   (NA)
Change at Month 4 Number Analyzed 1 participants 2 participants 1 participants
-2.23 [1]   (NA) 0.09  (0.040) -0.03 [1]   (NA)
Change at Month 5 Number Analyzed 0 participants 2 participants 0 participants
0.09  (0.081)
Change at Month 6 Number Analyzed 0 participants 1 participants 0 participants
0.29 [1]   (NA)
[1]
1 participant analyzed
14.Secondary Outcome
Title Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS
Hide Description The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Month 1 Number Analyzed 7 participants 3 participants 1 participants
-0.86  (1.975) -0.89  (1.159) -0.84 [1]   (NA)
Change at Month 2 Number Analyzed 5 participants 3 participants 1 participants
-2.40  (2.106) -2.02  (0.758) -1.40 [1]   (NA)
Change at Month 3 Number Analyzed 2 participants 3 participants 1 participants
-3.70  (3.616) -1.81  (0.430) -1.34 [1]   (NA)
Change at Month 4 Number Analyzed 1 participants 3 participants 1 participants
-6.43 [1]   (NA) -1.43  (1.078) -1.06 [1]   (NA)
Change at Month 5 Number Analyzed 0 participants 3 participants 0 participants
-1.40  (0.961)
Change at Month 6 Number Analyzed 0 participants 2 participants 0 participants
-1.36  (0.020)
[1]
1 participant analyzed
15.Secondary Outcome
Title Percent Change From Baseline to Each Month During the Treatment Period for DYS
Hide Description The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 6 2 0
Mean (Standard Deviation)
Unit of Measure: percent change of units on a scale
Percent Change at Month 1 Number Analyzed 6 participants 1 participants 0 participants
1.67  (109.961) -7.89 [1]   (NA)
Percent Change at Month 2 Number Analyzed 4 participants 1 participants 0 participants
-27.45  (17.119) -75.00 [1]   (NA)
Percent Change at Month 3 Number Analyzed 2 participants 1 participants 0 participants
-62.92  (24.159) -85.71 [1]   (NA)
Percent Change at Month 4 Number Analyzed 1 participants 1 participants 0 participants
-80.00 [1]   (NA) -16.67 [1]   (NA)
Percent Change at Month 5 Number Analyzed 0 participants 2 participants 0 participants
-40.48  (33.672)
Percent Change at Month 6 Number Analyzed 0 participants 1 participants 0 participants
-57.14 [1]   (NA)
[1]
1 participant analyzed
16.Secondary Outcome
Title Percent Change From Baseline to Each Month During the Treatment Period for NMPP
Hide Description The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 6 3 1
Mean (Standard Deviation)
Unit of Measure: percentage change of units on a scale
Percent Change at Month 1 Number Analyzed 6 participants 3 participants 1 participants
-11.81  (26.677) 4.22  (53.238) 16.07 [1]   (NA)
Percent Change at Month 2 Number Analyzed 5 participants 3 participants 1 participants
-37.53  (31.150) -34.21  (18.044) 11.90 [1]   (NA)
Percent Change at Month 3 Number Analyzed 2 participants 3 participants 1 participants
-38.26  (42.319) -38.03  (20.343) 22.62 [1]   (NA)
Percent Change at Month 4 Number Analyzed 1 participants 3 participants 1 participants
-71.21 [1]   (NA) -44.49  (20.725) 19.05 [1]   (NA)
Percent Change at Month 5 Number Analyzed 0 participants 3 participants 0 participants
-28.40  (33.641)
Percent Change at Month 6 Number Analyzed 0 participants 2 participants 0 participants
-17.23  (16.044)
[1]
1 participant analyzed
17.Secondary Outcome
Title Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia
Hide Description The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: percentage change of units on a scale
Percent Change at Month 1 Number Analyzed 7 participants 3 participants 1 participants
0.14  (18.180) -15.27  (26.791) -9.52 [1]   (NA)
Percent Change at Month 2 Number Analyzed 5 participants 3 participants 1 participants
6.60  (15.719) -15.26  (21.840) -12.38 [1]   (NA)
Percent Change at Month 3 Number Analyzed 2 participants 3 participants 1 participants
60.88  (65.632) -21.63  (24.719) -0.95 [1]   (NA)
Percent Change at Month 4 Number Analyzed 1 participants 3 participants 1 participants
106.25 [1]   (NA) -12.67  (20.433) -0.95 [1]   (NA)
Percent Change at Month 5 Number Analyzed 0 participants 3 participants 0 participants
-14.86  (16.002)
Percent Change at Month 6 Number Analyzed 0 participants 2 participants 0 participants
-18.08  (25.571)
[1]
1 participant analyzed
18.Secondary Outcome
Title Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS
Hide Description The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: percentage change of score on a scale
Percent Change at Month 1 Number Analyzed 7 participants 3 participants 1 participants
-14.10  (37.146) -19.61  (35.468) -11.34 [1]   (NA)
Percent Change at Month 2 Number Analyzed 5 participants 3 participants 1 participants
-37.82  (18.066) -56.25  (4.507) -18.99 [1]   (NA)
Percent Change at Month 3 Number Analyzed 2 participants 3 participants 1 participants
-43.98  (35.509) -53.05  (13.803) -18.22 [1]   (NA)
Percent Change at Month 4 Number Analyzed 1 participants 3 participants 1 participants
-70.98 [1]   (NA) -38.00  (31.275) -14.34 [1]   (NA)
Percent Change at Month 5 Number Analyzed 0 participants 3 participants 0 participants
-35.81  (9.326)
Percent Change at Month 6 Number Analyzed 0 participants 2 participants 0 participants
-33.56  (11.357)
[1]
1 participant analyzed
19.Secondary Outcome
Title Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics
Hide Description Based on average pill counts and assessed using a daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at baseline and given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: pills/day
NSAID: Change at Month 1 Number Analyzed 7 participants 3 participants 1 participants
-0.84  (0.796) 0.09  (0.388) -0.67 [1]   (NA)
NSAID: Change at Month 2 Number Analyzed 5 participants 3 participants 1 participants
-1.15  (0.785) -0.17  (0.834) 0.63 [1]   (NA)
NSAID: Change at Month 3 Number Analyzed 2 participants 3 participants 1 participants
-0.96  (1.030) -0.43  (1.091) -0.71 [1]   (NA)
NSAID: Change at Month 4 Number Analyzed 1 participants 3 participants 1 participants
-1.69 [1]   (NA) 0.01  (0.845) -0.63 [1]   (NA)
NSAID: Change at Month 5 Number Analyzed 0 participants 3 participants 0 participants
0.23  (1.197)
NSAID: Change at Month 6 Number Analyzed 0 participants 2 participants 0 participants
0.63  (0.606)
Opioid: Change at Month 1 Number Analyzed 7 participants 3 participants 1 participants
0.12  (0.552) -0.06  (0.099) -0.43 [1]   (NA)
Opioid: Change at Month 2 Number Analyzed 5 participants 3 participants 1 participants
-0.17  (0.263) -0.03  (0.049) -0.51 [1]   (NA)
Opioid: Change at Month 3 Number Analyzed 2 participants 3 participants 1 participants
-0.17  (0.242) 0.02  (0.016) -0.49 [1]   (NA)
Opioid: Change at Month 4 Number Analyzed 1 participants 3 participants 1 participants
-0.34 [1]   (NA) -0.01  (0.044) -0.40 [1]   (NA)
Opioid: Change at Month 5 Number Analyzed 0 participants 3 participants 0 participants
-0.05  (0.082)
Opioid: Change at Month 6 Number Analyzed 0 participants 2 participants 0 participants
0.09  (0.121)
NSAID + Opioid: Change at Month 1 Number Analyzed 7 participants 3 participants 1 participants
-0.72  (1.178) 0.03  (0.436) -1.10 [1]   (NA)
NSAID + Opioid: Change at Month 2 Number Analyzed 5 participants 3 participants 1 participants
-1.33  (0.767) -0.20  (0.830) -1.14 [1]   (NA)
NSAID + Opioid: Change at Month 3 Number Analyzed 2 participants 3 participants 1 participants
-1.13  (1.273) -0.41  (1.107) -1.20 [1]   (NA)
NSAID + Opioid: Change at Month 4 Number Analyzed 1 participants 3 participants 1 participants
-2.03 [1]   (NA) -0.00  (0.863) -1.03 [1]   (NA)
NSAID + Opioid: Change at Month 5 Number Analyzed 0 participants 3 participants 0 participants
0.18  (1.217)
NSAID + Opioid: Change at Month 6 Number Analyzed 0 participants 2 participants 0 participants
0.71  (0.485)
[1]
1 participant analyzed
20.Secondary Outcome
Title Number of Analgesic Use Responders and Non-Responders Over Time
Hide Description

Based only on reduction of rescue analgesics used. Responders were defined as:

  • participants with no analgesic use at screening and no analgesic use added
  • participants with NSAID only use at screening and NSAID dose stopped, decreased, or stable (<15% increase) and no opioid use added
  • participants with opioid only use at screening and opioid dose stopped, decreased, or stable (<15% increase), opioid dose stopped and NSAID substituted (any dose), opioid dose decreased and NSAID added (any dose)
  • participants with NSAID + opioid use at screening and any of the following: NSAID dose stopped + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose decreased + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose stable (< 15% increase) + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose increased by >15% + opioid analgesic use stopped; NSAID dose increased by >15% + opioid analgesic dose decreases.
Time Frame Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Measure Type: Count of Participants
Unit of Measure: Participants
Month 1: Responder
5
  71.4%
2
  66.7%
1
 100.0%
Month 1: Non-Responder
2
  28.6%
1
  33.3%
0
   0.0%
Month 2: Responder
4
  57.1%
2
  66.7%
1
 100.0%
Month 2: Non-Responder
1
  14.3%
1
  33.3%
0
   0.0%
Month 3: Responder
2
  28.6%
1
  33.3%
1
 100.0%
Month 3: Non-Responder
0
   0.0%
2
  66.7%
0
   0.0%
Month 4: Responder
1
  14.3%
2
  66.7%
1
 100.0%
Month 4: Non-Responder
0
   0.0%
1
  33.3%
0
   0.0%
Month 5: Responder
0
   0.0%
2
  66.7%
0
   0.0%
Month 5: Non-Responder
0
   0.0%
1
  33.3%
0
   0.0%
Month 6: Responder
0
   0.0%
0
   0.0%
0
   0.0%
Month 6: Non-Responder
0
   0.0%
2
  66.7%
0
   0.0%
21.Secondary Outcome
Title Patient Global Impression of Change (PGIC) Scores Over Time
Hide Description The PGIC is a 7-point response scale where participants rate their endometriosis related pain as: very much improved (1), much improved (2), minimally improved (3), not changed (4), minimally worse (5), much worse (6), very much worse (7).
Time Frame Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Month 1 Number Analyzed 7 participants 3 participants 1 participants
2.9  (1.35) 2.3  (0.58) 2.0 [1]   (NA)
Month 2 Number Analyzed 2 participants 3 participants 1 participants
2.0  (0.00) 1.3  (0.58) 2.0 [1]   (NA)
Month 3 Number Analyzed 1 participants 3 participants 1 participants
2.0 [1]   (NA) 2.0  (1.00) 5.0 [1]   (NA)
Month 4 Number Analyzed 0 participants 3 participants 1 participants
2.0  (1.00) 2.0 [1]   (NA)
Month 5 Number Analyzed 0 participants 2 participants 0 participants
2.5  (0.71)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
1.0 [1]   (NA)
[1]
1 participant analyzed
22.Secondary Outcome
Title Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time
Hide Description The endometriosis-associated pain questionnaire is an 11-point NRS assessing overall endometriosis-associated pain over a 7-day recall period. Participants assessed their endometriosis-associated pain on a scale of 0 to 10, with 0 = no pain and 10 = worst pain ever.
Time Frame Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 5 participants 3 participants 1 participants
8.2  (1.79) 9.0  (1.00) 7.0 [1]   (NA)
Month 1 Number Analyzed 7 participants 3 participants 1 participants
5.7  (3.04) 7.7  (1.15) 8.0 [1]   (NA)
Month 2 Number Analyzed 2 participants 3 participants 1 participants
4.5  (0.71) 2.7  (1.15) 5.0 [1]   (NA)
Month 3 Number Analyzed 1 participants 3 participants 1 participants
9.0 [1]   (NA) 5.3  (2.31) 8.0 [1]   (NA)
Month 4 Number Analyzed 0 participants 3 participants 1 participants
3.3  (0.58) 7.0 [1]   (NA)
Month 5 Number Analyzed 0 participants 2 participants 0 participants
8.0  (0.00)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
4.0 [1]   (NA)
[1]
1 participant analyzed
23.Secondary Outcome
Title Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain
Hide Description The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
59.42  (11.694) 47.73  (14.193) 59.09 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
38.07  (26.529) 17.42  (22.422) 38.64 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
27.27 [1]   (NA)
[1]
1 participant analyzed
24.Secondary Outcome
Title EHP-30 Scores Over Time: Control and Powerlessness
Hide Description The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
71.43  (19.159) 56.94  (19.691) 41.67 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
36.46  (32.874) 26.39  (21.382) 25.00 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
8.33 [1]   (NA)
[1]
1 participant analyzed
25.Secondary Outcome
Title EHP-30 Scores Over Time: Emotional Well-Being
Hide Description The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
29.76  (8.815) 50.00  (8.333) 45.83 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
18.75  (12.500) 23.61  (17.347) 37.50 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
25.00 [1]   (NA)
[1]
1 participant analyzed
26.Secondary Outcome
Title EHP-30 Scores Over Time: Social Support
Hide Description The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
48.21  (21.565) 45.83  (19.094) 50.00 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
17.19  (11.831) 16.67  (28.868) 18.75 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
25.00 [1]   (NA)
[1]
1 participant analyzed
27.Secondary Outcome
Title EHP-30 Scores Over Time: Self-Image
Hide Description The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
50.00  (22.048) 36.11  (31.549) 75.00 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
43.75  (41.597) 8.33  (14.434) 8.33 [1]   (NA)
Month 6 Number Analyzed 0 participants 3 participants 0 participants
16.67 [1]   (NA)
[1]
1 participant analyzed
28.Secondary Outcome
Title EHP-30 Scores Over Time: Sexual Intercourse
Hide Description The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 6 2 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 6 participants 2 participants 1 participants
70.00  (22.361) 62.50  (31.820) 60.00 [1]   (NA)
Month 3 Number Analyzed 4 participants 2 participants 1 participants
45.00  (23.452) 45.00  (42.426) 60.00 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
30.00 [1]   (NA)
[1]
1 participant analyzed
29.Secondary Outcome
Title EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility
Hide Description The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
1.4  (0.53) 1.0  (0.00) 1.0 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
1.3  (0.50) 1.0  (0.00) 2.0 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
1.0 [1]   (NA)
[1]
1 participant analyzed
30.Secondary Outcome
Title EQ-5D-5L Scores Over Time: Self-Care
Hide Description The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
1.0  (0.00) 1.0  (0.00) 1.0 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
1.0  (0.00) 1.0  (0.00) 1.0 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
1.0 [1]   (NA)
[1]
1 participant analyzed
31.Secondary Outcome
Title EQ-5D-5L Scores Over Time: Usual Activities
Hide Description The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
2.0  (0.82) 1.3  (0.58) 1.0 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
1.5  (0.58) 1.7  (1.15) 2.0 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
1.0 [1]   (NA)
[1]
1 participant analyzed
32.Secondary Outcome
Title EQ-5D-5L Scores Over Time: Pain/Discomfort
Hide Description The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
2.7  (0.76) 2.7  (0.58) 4.0 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
2.0  (1.15) 1.7  (0.58) 3.0 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
1.0 [1]   (NA)
[1]
1 participant analyzed
33.Secondary Outcome
Title EQ-5D-5L Scores Over Time: Anxiety/Depression
Hide Description The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
1.0  (0.00) 1.3  (0.58) 1.0 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
1.0  (0.00) 1.0  (0.00) 1.0 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
1.0 [1]   (NA)
[1]
1 participant analyzed
34.Secondary Outcome
Title EQ-5D-5L VAS Scores Over Time: Health Today
Hide Description The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate VAS indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable).
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
79.7  (15.16) 53.3  (35.12) 72.0 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
72.8  (17.63) 85.0  (15.00) 70.0 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
94.0 [1]   (NA)
[1]
1 participant analyzed
35.Secondary Outcome
Title Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem
Hide Description Absenteeism is presented as the mean percentage of work time missed due to health problem (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to health problem / (number of hours of work missed due to health problem + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 6 3 0
Mean (Standard Deviation)
Unit of Measure: percent of work time missed
Baseline Number Analyzed 6 participants 3 participants 0 participants
0.16  (0.205) 0.08  (0.144)
Month 6 Number Analyzed 3 participants 1 participants 0 participants
0.00  (0.000) 0.00 [1]   (NA)
[1]
1 participant analyzed
36.Secondary Outcome
Title WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem
Hide Description Presenteeism (the extent to which health problem decreased productivity) is presented as the mean percentage of impairment while working due to health problem, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 6 3 0
Mean (Standard Deviation)
Unit of Measure: percent impairment while working
Baseline Number Analyzed 6 participants 3 participants 0 participants
0.57  (0.273) 0.53  (0.153)
Month 6 Number Analyzed 3 participants 1 participants 0 participants
0.30  (0.265) 0.30 [1]   (NA)
[1]
1 participant analyzed
37.Secondary Outcome
Title WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem
Hide Description The mean percentage of overall work impairment due to health problem (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which health problem decreased productivity (%)* [number of hours worked / (number of hours of work missed due to health problem + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 6 3 0
Mean (Standard Deviation)
Unit of Measure: percent overall work impairment
Baseline Number Analyzed 6 participants 3 participants 0 participants
0.61  (0.307) 0.56  (0.194)
Month 6 Number Analyzed 3 participants 1 participants 0 participants
0.30  (0.265) 0.30 [1]   (NA)
[1]
1 participant analyzed
38.Secondary Outcome
Title WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem
Hide Description Activity impairment due to health problem (the extent to which health problem affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity.
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: percentage impairment of activity
Baseline Number Analyzed 7 participants 3 participants 1 participants
0.66  (0.237) 0.67  (0.058) 0.70 [1]   (NA)
Month 6 Number Analyzed 3 participants 1 participants 1 participants
0.40  (0.346) 0.30 [1]   (NA) 0.70 [1]   (NA)
[1]
1 participant analyzed
39.Secondary Outcome
Title Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time
Hide Description The 6-item ETSQ was developed to assess patient-reported satisfaction with effects on endometriosis pain, dysmenorrhea, dyspareunia, amount of bleeding tolerability and overall treatment satisfaction. The ETSQ has a 7 point response scale. The range for this scale is 0 to 36, with lower ETSQ scores reflecting lower levels of satisfaction with endometriosis treatment.
Time Frame Month 0 (baseline), Months 3, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
19.71  (4.536) 18.00  (0.000) 18.00 [1]   (NA)
Month 3 Number Analyzed 4 participants 3 participants 1 participants
22.25  (9.430) 25.47  (6.652) 25.00 [1]   (NA)
Month 6 Number Analyzed 0 participants 1 participants 0 participants
31.00 [1]   (NA)
[1]
1 participant analyzed
40.Secondary Outcome
Title PROMIS Fatigue Short Form 6a Scores Over Time
Hide Description The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue. Possible scores range from 6 to 30, 6 = not at all (no fatigue), and 30 = very much (most fatigue).
Time Frame Month 0 (baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with an assessment at given time point.
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description:

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Overall Number of Participants Analyzed 7 3 1
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 7 participants 3 participants 1 participants
22.1  (4.10) 19.3  (6.11) 27.0 [1]   (NA)
Month 6 Number Analyzed 3 participants 1 participants 1 participants
15.3  (7.77) 11.0 [1]   (NA) 21.0 [1]   (NA)
[1]
1 participant analyzed
Time Frame From first dose of study drug up to 6 months, plus 30 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group A Group B Group C
Hide Arm/Group Description

Day 1 through Month 3 (open-label): elagolix 150 mg QD

Participants discontinued prematurely during the open-label period.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD

Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group

The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window.

All-Cause Mortality
Group A Group B Group C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/3 (0.00%)      0/1 (0.00%)    
Hide Serious Adverse Events
Group A Group B Group C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/3 (0.00%)      0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group A Group B Group C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/7 (42.86%)      3/3 (100.00%)      1/1 (100.00%)    
Ear and labyrinth disorders       
EAR DISCOMFORT  1  0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
Gastrointestinal disorders       
ABDOMINAL PAIN UPPER  1  0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
DIARRHOEA  1  1/7 (14.29%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0
NAUSEA  1  2/7 (28.57%)  2 0/3 (0.00%)  0 0/1 (0.00%)  0
VOMITING  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
General disorders       
CHILLS  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
FATIGUE  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Immune system disorders       
ANAPHYLACTIC REACTION  1  0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
DRUG HYPERSENSITIVITY  1  0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Infections and infestations       
GARDNERELLA INFECTION  1  0/7 (0.00%)  0 1/3 (33.33%)  1 1/1 (100.00%)  1
ORAL HERPES  1  0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
URINARY TRACT INFECTION  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
VAGINAL INFECTION  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Metabolism and nutrition disorders       
POLYDIPSIA  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Nervous system disorders       
HEADACHE  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders       
IRRITABILITY  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Reproductive system and breast disorders       
ADNEXA UTERI PAIN  1  0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
DYSMENORRHOEA  1  0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
MENSTRUATION DELAYED  1  0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
PELVIC PAIN  1  0/7 (0.00%)  0 1/3 (33.33%)  1 1/1 (100.00%)  1
Respiratory, thoracic and mediastinal disorders       
THROAT TIGHTNESS  1  0/7 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1
Skin and subcutaneous tissue disorders       
DERMATITIS ALLERGIC  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
NIGHT SWEATS  1  1/7 (14.29%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0
Vascular disorders       
HOT FLUSH  1  0/7 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Due to early study termination at Treatment Month 6 with low subject enrollment, no clinically or statistically meaningful efficacy conclusions can be made. The study was terminated early for business reasons, not for safety concerns.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03343067    
Other Study ID Numbers: M16-383
First Submitted: November 13, 2017
First Posted: November 17, 2017
Results First Submitted: October 22, 2019
Results First Posted: November 27, 2019
Last Update Posted: November 27, 2019