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Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

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ClinicalTrials.gov Identifier: NCT02143713
Recruitment Status : Completed
First Posted : May 21, 2014
Results First Posted : September 7, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Endometriosis
Intervention Drug: Elagolix
Enrollment 496
Recruitment Details

Participants who completed the 6-month Treatment Period in the pivotal Study M12-671 (NCT01931670) could enter this extension study.

A total of 96 participants were enrolled at 148 sites in North and South America, Europe, Australia/New Zealand, and South Africa. One enrolled patient did not receive study drug and is not included in these results.

Pre-assignment Details The study consisted of a 6-month Treatment Period and a Post-treatment Follow-up (PTFU) of up to 12 months. Participants who received elagolix in the pivotal study continued to receive the same dose for a further 6 months; participants on placebo in the pivotal study were randomized 1:1 to either elagolix 150 mg once daily or 200 mg twice daily.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg once daily (QD) for 6 months in this extension Study M12-821. Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg twice daily (BID) for 6 months in this extension Study M12-821. Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821. Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Period Title: Treatment Period (6 Months)
Started 102 111 142 140
Received Elagolix 102 111 142 140
Completed 82 99 120 112
Not Completed 20 12 22 28
Reason Not Completed
Withdrawal by Subject             1             2             5             4
Adverse Event             7             8             8             9
Lost to Follow-up             3             0             4             3
Surgery or Invasive Intervention             2             0             0             2
Pregnancy             0             2             2             0
Non-compliance             1             0             0             3
Other             3             0             3             2
Bone Mineral Density (BMD) Decrease             0             0             0             4
Exclusionary Medication             2             0             0             0
Lack of Efficacy             1             0             0             1
Period Title: Post-treatment Follow-up (12 Months)
Started [1] 85 105 125 122
Completed 73 81 96 95
Not Completed 12 24 29 27
Reason Not Completed
Withdrawal by Subject             4             7             6             10
Adverse Event             0             0             1             0
Lost to Follow-up             3             8             11             8
Surgery or Invasive Intervention             2             4             4             1
Exclusionary Medication             0             1             0             1
Other             3             4             7             7
[1]
Participants who completed the 6-month Treatment Period or prematurely discontinued could enter PTFU
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Total
Hide Arm/Group Description Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821. Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821. Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821. Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821. Total of all reporting groups
Overall Number of Baseline Participants 102 111 142 140 495
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 111 participants 142 participants 140 participants 495 participants
33.5  (7.00) 33.2  (6.32) 33.2  (7.02) 34.1  (6.70) 33.5  (6.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 111 participants 142 participants 140 participants 495 participants
Female
102
 100.0%
111
 100.0%
142
 100.0%
140
 100.0%
495
 100.0%
Male
0
   0.0%
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 102 participants 111 participants 142 participants 140 participants 495 participants
Hispanic or Latino
14
  13.7%
11
   9.9%
15
  10.6%
21
  15.0%
61
  12.3%
Not Hispanic or Latino
88
  86.3%
100
  90.1%
127
  89.4%
119
  85.0%
434
  87.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 111 participants 142 participants 140 participants 495 participants
White
94
  92.2%
100
  90.1%
127
  89.4%
126
  90.0%
447
  90.3%
Black or African American
7
   6.9%
9
   8.1%
14
   9.9%
12
   8.6%
42
   8.5%
Asian
0
   0.0%
1
   0.9%
1
   0.7%
1
   0.7%
3
   0.6%
Multi race
0
   0.0%
1
   0.9%
0
   0.0%
1
   0.7%
2
   0.4%
Native Hawaiian or other pacific islander
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.2%
1.Primary Outcome
Title Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment
Hide Description

Response was defined as a reduction of –0.85 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671.

Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following:

  • 0: No discomfort
  • 1: Mild discomfort but I was easily able to do the things I usually do
  • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
  • 3: Severe pain that made it difficult to do the things I usually do.

Analgesic use and pain scores were averaged over the 35 days prior to each visit.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 81 98 122 116
Measure Type: Number
Unit of Measure: percentage of participants
37.0 57.1 50.8 75.9
2.Primary Outcome
Title Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
Hide Description

Response was defined as a reduction of −0.43 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671.

Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:

  • 0: No discomfort
  • 1: Mild discomfort but I was easily able to do the things I usually do
  • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
  • 3: Severe pain that made it difficult to do the things I usually do.

Pain scores and analgesic use were averaged over the 35 days prior to each visit.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 81 98 122 116
Measure Type: Number
Unit of Measure: percentage of participants
27.2 32.7 66.4 67.2
3.Secondary Outcome
Title Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment
Hide Description

Response was defined as a reduction of –0.85 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671.

Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following:

  • 0: No discomfort
  • 1: Mild discomfort but I was easily able to do the things I usually do
  • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
  • 3: Severe pain that made it difficult to do the things I usually do.

Analgesic use and pain scores were averaged over the 35 days prior to each visit.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 102 participants 110 participants 141 participants 140 participants
11.8 24.5 56.7 74.3
Month 2 Number Analyzed 96 participants 106 participants 136 participants 134 participants
36.5 62.3 52.2 79.1
Month 3 Number Analyzed 90 participants 103 participants 133 participants 131 participants
30.0 64.1 48.1 77.1
Month 4 Number Analyzed 88 participants 102 participants 128 participants 125 participants
33.0 64.7 47.7 80.0
Month 5 Number Analyzed 81 participants 100 participants 126 participants 117 participants
30.9 59.0 53.2 82.9
4.Secondary Outcome
Title Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment
Hide Description

Response was defined as a reduction of −0.43 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-671.

Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:

  • 0: No discomfort
  • 1: Mild discomfort but I was easily able to do the things I usually do
  • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
  • 3: Severe pain that made it difficult to do the things I usually do.

Pain scores and analgesic use were averaged over the 35 days prior to each visit.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 102 participants 110 participants 141 participants 140 participants
12.7 18.2 61.7 62.1
Month 2 Number Analyzed 96 participants 106 participants 136 participants 134 participants
20.8 27.4 61.8 63.4
Month 3 Number Analyzed 90 participants 103 participants 133 participants 131 participants
18.9 29.1 66.2 65.6
Month 4 Number Analyzed 88 participants 102 participants 128 participants 125 participants
27.3 34.3 64.8 66.4
Month 5 Number Analyzed 81 participants 100 participants 126 participants 117 participants
28.4 33.0 67.5 72.6
5.Secondary Outcome
Title Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment
Hide Description

Response was defined as a reduction of −0.29 or more from baseline in dyspareunia (pain during sexual intercourse) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a < 15% increase in average rescue analgesic pill count and no additional analgesics).

Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed dyspareunia each day in an e-Diary. Dyspareunia was assessed according to the following:

  • 0: None; No discomfort during sexual intercourse
  • 1: Mild; Able to tolerate the discomfort during sexual intercourse
  • 2: Moderate; Intercourse was interrupted due to pain
  • 3: Severe; Avoided intercourse because of pain
  • Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.

Pain scores and analgesic use were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point; if a participant's mean score was not defined because all reports in that month were "Not Applicable," then that mean score was treated as missing.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 78 participants 77 participants 101 participants 93 participants
23.1 27.3 50.5 63.4
Month 2 Number Analyzed 72 participants 77 participants 100 participants 95 participants
30.6 35.1 47.0 65.3
Month 3 Number Analyzed 67 participants 72 participants 97 participants 85 participants
37.3 33.3 55.7 61.2
Month 4 Number Analyzed 66 participants 65 participants 98 participants 83 participants
34.8 32.3 54.1 60.2
Month 5 Number Analyzed 60 participants 65 participants 86 participants 74 participants
30.0 40.0 52.3 63.5
Month 6 Number Analyzed 59 participants 67 participants 85 participants 74 participants
28.8 31.3 45.9 58.1
6.Secondary Outcome
Title Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment
Hide Description

Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary according to the following response options:

  • 0: No discomfort
  • 1: Mild discomfort but I was easily able to do the things I usually do
  • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
  • 3: Severe pain that made it difficult to do the things I usually do.

Pain scores were averaged over the 35 days prior to each visit.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 Number Analyzed 98 participants 108 participants 141 participants 140 participants
-18.4  (41.71) -27.0  (55.50) -54.6  (41.79) -81.3  (36.00)
Month 2 Number Analyzed 92 participants 104 participants 136 participants 134 participants
-47.6  (50.17) -70.2  (55.81) -50.7  (41.16) -84.0  (33.76)
Month 3 Number Analyzed 86 participants 101 participants 133 participants 131 participants
-40.2  (51.63) -76.7  (48.73) -49.0  (41.98) -84.8  (32.01)
Month 4 Number Analyzed 84 participants 100 participants 128 participants 125 participants
-40.3  (51.25) -77.5  (41.25) -50.5  (39.97) -83.0  (36.23)
Month 5 Number Analyzed 78 participants 98 participants 126 participants 117 participants
-38.0  (50.01) -75.6  (47.88) -51.8  (39.25) -82.7  (33.89)
Month 6 Number Analyzed 78 participants 96 participants 122 participants 116 participants
-44.6  (45.08) -80.7  (38.43) -52.9  (39.52) -81.8  (33.57)
7.Secondary Outcome
Title Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment
Hide Description

Participants assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options:

  • 0: No discomfort
  • 1: Mild discomfort but I was easily able to do the things I usually do
  • 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do
  • 3: Severe pain that made it difficult to do the things I usually do.

Pain scores were averaged over the 35 days prior to each visit.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 Number Analyzed 98 participants 107 participants 141 participants 140 participants
-7.3  (57.59) -11.3  (64.29) -47.9  (39.03) -54.0  (41.77)
Month 2 Number Analyzed 92 participants 103 participants 136 participants 134 participants
-7.8  (71.50) -12.8  (143.81) -48.6  (38.70) -53.1  (42.04)
Month 3 Number Analyzed 86 participants 100 participants 133 participants 131 participants
-24.5  (53.77) -17.8  (130.92) -50.7  (38.41) -54.5  (41.70)
Month 4 Number Analyzed 84 participants 99 participants 128 participants 125 participants
-25.0  (53.14) -23.1  (123.65) -53.2  (37.47) -54.4  (40.89)
Month 5 Number Analyzed 77 participants 97 participants 126 participants 117 participants
-30.4  (44.88) -31.2  (113.03) -54.9  (39.53) -57.4  (42.84)
Month 6 Number Analyzed 77 participants 95 participants 122 participants 116 participants
-24.0  (62.40) -27.2  (164.50) -53.6  (40.41) -55.9  (41.01)
8.Secondary Outcome
Title Percent Change From Baseline in Dyspareunia Based on Daily Assessment
Hide Description

Participants assessed dyspareunia each day in an e-Diary according to the following response options:

  • 0: None; No discomfort during sexual intercourse
  • 1: Mild; Able to tolerate the discomfort during sexual intercourse
  • 2: Moderate; Intercourse was interrupted due to pain
  • 3: Severe; Avoided intercourse because of pain
  • Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse.

Pain scores were averaged over the 35 days prior to each visit. Responses of "Not Applicable" were excluded.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study and with available baseline data and data at each time point; participants with responses of 'Not Applicable' on all reported days during baseline or for the entire time point were excluded from the analysis.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 83 87 118 108
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 Number Analyzed 63 participants 64 participants 95 participants 87 participants
-10.4  (52.31) -16.9  (59.04) -43.7  (64.77) -48.7  (66.94)
Month 2 Number Analyzed 60 participants 64 participants 93 participants 89 participants
-12.0  (51.80) -19.2  (65.67) -38.0  (74.89) -51.1  (52.74)
Month 3 Number Analyzed 54 participants 62 participants 91 participants 78 participants
-22.1  (46.07) -26.4  (69.18) -43.4  (55.71) -49.1  (46.47)
Month 4 Number Analyzed 53 participants 57 participants 93 participants 77 participants
-22.3  (51.64) -12.6  (141.47) -49.1  (48.27) -48.5  (56.42)
Month 5 Number Analyzed 48 participants 55 participants 80 participants 68 participants
-25.7  (45.51) -9.5  (191.05) -57.0  (43.57) -42.7  (64.12)
Month 6 Number Analyzed 46 participants 55 participants 79 participants 69 participants
-18.8  (54.07) -28.3  (53.62) -51.3  (45.87) -49.7  (54.23)
9.Secondary Outcome
Title Change From Baseline in Any Rescue Analgesic Use
Hide Description Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, or codeine 30 mg + acetaminophen 300 mg, or codeine 30 mg, or tramadol 37.5 mg + acetaminophen 325 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Any rescue analgesic use (NSAID and/or opioid) was calculated as the total number of pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Mean (Standard Deviation)
Unit of Measure: pills/day
Month 1 Number Analyzed 102 participants 110 participants 141 participants 140 participants
-0.07  (0.320) -0.16  (0.389) -0.44  (0.745) -0.47  (0.711)
Month 2 Number Analyzed 96 participants 106 participants 136 participants 134 participants
-0.16  (0.375) -0.24  (0.510) -0.49  (0.829) -0.52  (0.774)
Month 3 Number Analyzed 90 participants 103 participants 133 participants 131 participants
-0.14  (0.391) -0.24  (0.524) -0.46  (0.806) -0.53  (0.774)
Month 4 Number Analyzed 88 participants 102 participants 128 participants 125 participants
-0.13  (0.460) -0.28  (0.483) -0.48  (0.815) -0.54  (0.811)
Month 5 Number Analyzed 81 participants 100 participants 126 participants 117 participants
-0.16  (0.446) -0.29  (0.539) -0.46  (0.817) -0.57  (0.758)
Month 6 Number Analyzed 81 participants 98 participants 122 participants 116 participants
-0.16  (0.410) -0.28  (0.513) -0.45  (0.834) -0.59  (0.799)
10.Secondary Outcome
Title Change From Baseline in NSAID Rescue Analgesic Use
Hide Description Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, or codeine 30 mg + acetaminophen 300 mg, or codeine 30 mg, or tramadol 37.5 mg + acetaminophen 325 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. NSAID rescue analgesic use was calculated as the total number of NSAID pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Mean (Standard Deviation)
Unit of Measure: pills/day
Month 1 Number Analyzed 102 participants 110 participants 141 participants 140 participants
-0.05  (0.209) -0.12  (0.263) -0.25  (0.590) -0.28  (0.363)
Month 2 Number Analyzed 96 participants 106 participants 136 participants 134 participants
-0.10  (0.271) -0.18  (0.343) -0.29  (0.624) -0.29  (0.389)
Month 3 Number Analyzed 90 participants 103 participants 133 participants 131 participants
-0.11  (0.281) -0.18  (0.336) -0.27  (0.550) -0.30  (0.370)
Month 4 Number Analyzed 88 participants 102 participants 128 participants 125 participants
-0.09  (0.297) -0.20  (0.334) -0.28  (0.531) -0.30  (0.379)
Month 5 Number Analyzed 81 participants 100 participants 126 participants 117 participants
-0.11  (0.316) -0.21  (0.353) -0.27  (0.556) -0.31  (0.376)
Month 6 Number Analyzed 81 participants 98 participants 122 participants 116 participants
-0.10  (0.241) -0.20  (0.369) -0.26  (0.569) -0.32  (0.380)
11.Secondary Outcome
Title Change From Baseline in Opioid Rescue Analgesic Use
Hide Description Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, or codeine 30 mg + acetaminophen 300 mg, or codeine 30 mg, or tramadol 37.5 mg + acetaminophen 325 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Opioid rescue analgesic use was calculated as the total number of opioid pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Mean (Standard Deviation)
Unit of Measure: pills/day
Month 1 Number Analyzed 102 participants 110 participants 141 participants 140 participants
-0.02  (0.197) -0.04  (0.243) -0.19  (0.526) -0.20  (0.596)
Month 2 Number Analyzed 96 participants 106 participants 136 participants 134 participants
-0.06  (0.214) -0.06  (0.270) -0.19  (0.573) -0.23  (0.655)
Month 3 Number Analyzed 90 participants 103 participants 133 participants 131 participants
-0.04  (0.217) -0.06  (0.309) -0.19  (0.613) -0.23  (0.662)
Month 4 Number Analyzed 88 participants 102 participants 128 participants 125 participants
-0.05  (0.262) -0.08  (0.231) -0.20  (0.620) -0.24  (0.693)
Month 5 Number Analyzed 81 participants 100 participants 126 participants 117 participants
-0.05  (0.227) -0.08  (0.273) -0.19  (0.613) -0.26  (0.643)
Month 6 Number Analyzed 81 participants 98 participants 122 participants 116 participants
-0.06  (0.237) -0.07  (0.271) -0.20  (0.623) -0.27  (0.680)
12.Secondary Outcome
Title Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS)
Hide Description The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Participants were asked to assess their endometriosis pain over the past 24 hours at it's worst at approximately the same time every day in the e-Diary. Pain scores were averaged over the 35 days prior to each visit.
Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 Number Analyzed 102 participants 110 participants 141 participants 140 participants
-12.0  (44.71) -18.2  (51.75) -50.8  (36.58) -58.7  (37.07)
Month 2 Number Analyzed 96 participants 106 participants 136 participants 134 participants
-20.7  (40.87) -25.8  (87.35) -50.7  (36.08) -58.7  (36.31)
Month 3 Number Analyzed 90 participants 103 participants 133 participants 131 participants
-27.7  (39.61) -35.0  (65.06) -52.7  (36.40) -59.5  (35.99)
Month 4 Number Analyzed 88 participants 102 participants 128 participants 125 participants
-31.2  (43.28) -38.8  (58.04) -54.7  (33.26) -60.4  (34.77)
Month 5 Number Analyzed 81 participants 100 participants 126 participants 117 participants
-29.2  (52.99) -45.6  (60.86) -56.1  (35.81) -62.3  (34.99)
Month 6 Number Analyzed 81 participants 98 participants 122 participants 116 participants
-30.7  (42.08) -41.7  (83.80) -53.9  (35.06) -61.1  (33.71)
13.Secondary Outcome
Title Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved
Hide Description

The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories:

  1. Very Much Improved
  2. Much Improved
  3. Minimally Improved
  4. Not Changed
  5. Minimally Worse
  6. Much Worse
  7. Very Much Worse
Time Frame Months 1, 2, 3, 4, 5, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 98 participants 111 participants 137 participants 138 participants
50.0 56.8 65.7 78.3
Month 2 Number Analyzed 92 participants 106 participants 136 participants 133 participants
58.7 74.5 69.1 78.9
Month 3 Number Analyzed 88 participants 103 participants 131 participants 127 participants
63.6 70.9 67.9 77.2
Month 4 Number Analyzed 88 participants 101 participants 128 participants 123 participants
61.4 75.2 71.1 82.1
Month 5 Number Analyzed 82 participants 100 participants 124 participants 117 participants
67.1 81.0 71.8 82.1
Month 6 Number Analyzed 76 participants 93 participants 114 participants 106 participants
65.8 76.3 75.4 84.0
14.Secondary Outcome
Title Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension
Hide Description

The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and includes pain, control and powerlessness, emotional well-being, social support, and self-image, and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis.

Each question in the core questionnaire is scored on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always.

The pain dimension consists of 11 questions. The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 Number Analyzed 98 participants 111 participants 136 participants 138 participants
-8.02  (17.828) -12.18  (17.465) -32.25  (21.235) -36.45  (22.320)
Month 3 Number Analyzed 92 participants 104 participants 136 participants 129 participants
-11.12  (22.424) -15.25  (21.467) -32.00  (23.172) -37.42  (21.492)
Month 6 Number Analyzed 74 participants 92 participants 110 participants 100 participants
-10.60  (20.827) -15.61  (21.047) -32.95  (23.674) -38.48  (21.924)
15.Secondary Outcome
Title Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension
Hide Description

The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis; only 1 modular questionnaire (sexual intercourse [5 items]) was used in this study.

The Sexual Intercourse dimension consists of 5 questions, each answered on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always, or Not Applicable (not scored). The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and months 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 90 97 109 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 Number Analyzed 79 participants 71 participants 90 participants 98 participants
-3.29  (13.655) -10.35  (16.846) -24.17  (26.010) -28.37  (29.886)
Month 3 Number Analyzed 68 participants 64 participants 90 participants 86 participants
-9.26  (20.264) -12.50  (22.449) -24.61  (26.986) -28.66  (31.580)
Month 6 Number Analyzed 55 participants 63 participants 78 participants 67 participants
-9.36  (19.294) -7.30  (22.963) -23.21  (26.310) -33.21  (31.988)
16.Secondary Outcome
Title Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household
Hide Description

The HRPQ consists of 9 questions measuring the impact of endometriosis-associated pain and its treatment on work productivity and daily activities in the home.

Absenteeism: Number of hours of intended work lost due to illness or treatment. Presenteeism: Number of hours of work where output was impacted by illness or treatments.

Total hours lost is the sum of hours missed due to absenteeism plus presenteeism.

Time Frame Baseline (defined as baseline of Study M12-671 for participants who received elagolix in the pivotal study and baseline of the extension study M12-821 for participants who received placebo in the pivotal study) and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point. Hours lost from workplace were only calculated for participants who were employed.
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 91 102 126 130
Mean (Standard Deviation)
Unit of Measure: hours
Absenteeism from workplace Number Analyzed 49 participants 67 participants 77 participants 72 participants
-2.82  (5.648) -1.33  (8.945) -1.25  (4.377) -1.73  (4.133)
Presenteeism from workplace Number Analyzed 48 participants 67 participants 76 participants 68 participants
-10.31  (15.902) -8.37  (9.675) -8.38  (12.489) -10.63  (9.837)
Total hours of work lost from workplace Number Analyzed 49 participants 67 participants 77 participants 72 participants
-13.22  (16.663) -9.70  (13.683) -9.36  (13.365) -12.02  (10.447)
Absenteeism from household Number Analyzed 58 participants 71 participants 88 participants 88 participants
-3.17  (6.241) -2.68  (3.779) -3.56  (4.924) -3.50  (4.180)
Presenteeism from household Number Analyzed 58 participants 71 participants 86 participants 84 participants
-2.47  (6.581) -2.19  (4.973) -2.33  (5.182) -2.74  (5.308)
Total hours of work lost from household Number Analyzed 58 participants 71 participants 88 participants 88 participants
-5.64  (9.919) -4.86  (7.185) -5.84  (7.844) -6.17  (7.930)
17.Secondary Outcome
Title Number of Participants With Non-study Health Visits During the Treatment Period
Hide Description The Health Resource Use Questionnaire (HRUQ) was used to collect information on non–study-related health visits that participants had during the study.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 102 111 142 140
Measure Type: Count of Participants
Unit of Measure: Participants
48
  47.1%
65
  58.6%
76
  53.5%
76
  54.3%
18.Secondary Outcome
Title Number of Days in Hospital During the Treatment Period
Hide Description The Health Resource Use Questionnaire (HRUQ) was used to collect information on non–study-related health visits that participants had during the study, including physician visits, hospitalizations and types of procedures received.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who received at least 1 dose of double-blind study drug in this extension study and who underwent hospitalization
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821.
Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
Overall Number of Participants Analyzed 9 11 10 13
Median (Full Range)
Unit of Measure: days
2.0
(1 to 6)
4.0
(2 to 13)
3.0
(1 to 7)
3.0
(1 to 7)
Time Frame From the date of the first dose of study drug in Study M12-821 through up to 30 days after the last dose of study drug (up to 7 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Hide Arm/Group Description Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-821. Participants who received placebo in pivotal Study M12-671 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-821. Participants were randomized to elagolix 150 mg QD in pivotal Study M12-671 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-821. Participants were randomized to elagolix 200 mg BID in pivotal Study M12-671 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-821.
All-Cause Mortality
Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)      0/111 (0.00%)      0/142 (0.00%)      0/140 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/102 (3.92%)      8/111 (7.21%)      7/142 (4.93%)      8/140 (5.71%)    
Gastrointestinal disorders         
ABDOMINAL HERNIA  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
ABDOMINAL PAIN  1  2/102 (1.96%)  2 0/111 (0.00%)  0 1/142 (0.70%)  1 1/140 (0.71%)  1
ABDOMINAL PAIN LOWER  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
GASTROINTESTINAL MOTILITY DISORDER  1  0/102 (0.00%)  0 0/111 (0.00%)  0 1/142 (0.70%)  1 0/140 (0.00%)  0
IRRITABLE BOWEL SYNDROME  1  0/102 (0.00%)  0 1/111 (0.90%)  1 0/142 (0.00%)  0 0/140 (0.00%)  0
General disorders         
PYREXIA  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
Hepatobiliary disorders         
CHOLELITHIASIS  1  0/102 (0.00%)  0 0/111 (0.00%)  0 1/142 (0.70%)  1 0/140 (0.00%)  0
Infections and infestations         
DENGUE FEVER  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
DIVERTICULITIS  1  0/102 (0.00%)  0 1/111 (0.90%)  1 0/142 (0.00%)  0 0/140 (0.00%)  0
POSTOPERATIVE WOUND INFECTION  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
Injury, poisoning and procedural complications         
CARBON MONOXIDE POISONING  1  0/102 (0.00%)  0 1/111 (0.90%)  1 0/142 (0.00%)  0 0/140 (0.00%)  0
INCISIONAL HERNIA  1  1/102 (0.98%)  1 0/111 (0.00%)  0 0/142 (0.00%)  0 0/140 (0.00%)  0
LIGAMENT RUPTURE  1  0/102 (0.00%)  0 1/111 (0.90%)  1 0/142 (0.00%)  0 0/140 (0.00%)  0
PROCEDURAL HYPERTENSION  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
TIBIA FRACTURE  1  0/102 (0.00%)  0 1/111 (0.90%)  1 0/142 (0.00%)  0 0/140 (0.00%)  0
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  1/102 (0.98%)  1 0/111 (0.00%)  0 0/142 (0.00%)  0 0/140 (0.00%)  0
OSTEOCHONDROSIS  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
PELVIC NEOPLASM  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
TERATOMA  1  0/102 (0.00%)  0 0/111 (0.00%)  0 1/142 (0.70%)  1 0/140 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
ABORTION SPONTANEOUS  1  0/102 (0.00%)  0 1/111 (0.90%)  1 0/142 (0.00%)  0 0/140 (0.00%)  0
Psychiatric disorders         
ANXIETY  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
Reproductive system and breast disorders         
OVARIAN CYST  1  0/102 (0.00%)  0 1/111 (0.90%)  1 0/142 (0.00%)  0 0/140 (0.00%)  0
PELVIC PAIN  1  0/102 (0.00%)  0 1/111 (0.90%)  1 1/142 (0.70%)  1 1/140 (0.71%)  1
PERINEAL PAIN  1  0/102 (0.00%)  0 0/111 (0.00%)  0 1/142 (0.70%)  1 0/140 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
CHRONIC OBSTRUCTIVE PULMONARY DISEASE  1  0/102 (0.00%)  0 1/111 (0.90%)  1 0/142 (0.00%)  0 0/140 (0.00%)  0
DYSPNOEA  1  0/102 (0.00%)  0 0/111 (0.00%)  0 0/142 (0.00%)  0 1/140 (0.71%)  1
NASAL POLYPS  1  0/102 (0.00%)  0 0/111 (0.00%)  0 1/142 (0.70%)  1 0/140 (0.00%)  0
Surgical and medical procedures         
ABORTION INDUCED  1  0/102 (0.00%)  0 0/111 (0.00%)  0 2/142 (1.41%)  2 0/140 (0.00%)  0
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   49/102 (48.04%)      74/111 (66.67%)      65/142 (45.77%)      70/140 (50.00%)    
Gastrointestinal disorders         
NAUSEA  1  6/102 (5.88%)  6 13/111 (11.71%)  14 14/142 (9.86%)  15 5/140 (3.57%)  5
General disorders         
FATIGUE  1  0/102 (0.00%)  0 6/111 (5.41%)  6 0/142 (0.00%)  0 2/140 (1.43%)  2
Infections and infestations         
NASOPHARYNGITIS  1  6/102 (5.88%)  6 10/111 (9.01%)  10 6/142 (4.23%)  6 9/140 (6.43%)  10
SINUSITIS  1  6/102 (5.88%)  6 6/111 (5.41%)  8 8/142 (5.63%)  9 8/140 (5.71%)  8
UPPER RESPIRATORY TRACT INFECTION  1  5/102 (4.90%)  6 6/111 (5.41%)  7 6/142 (4.23%)  8 6/140 (4.29%)  7
URINARY TRACT INFECTION  1  3/102 (2.94%)  3 9/111 (8.11%)  12 10/142 (7.04%)  11 11/140 (7.86%)  13
Investigations         
BONE DENSITY DECREASED  1  1/102 (0.98%)  1 2/111 (1.80%)  2 0/142 (0.00%)  0 8/140 (5.71%)  8
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  9/102 (8.82%)  10 12/111 (10.81%)  13 6/142 (4.23%)  6 9/140 (6.43%)  10
BACK PAIN  1  2/102 (1.96%)  2 6/111 (5.41%)  7 6/142 (4.23%)  6 10/140 (7.14%)  11
Nervous system disorders         
HEADACHE  1  13/102 (12.75%)  15 18/111 (16.22%)  20 9/142 (6.34%)  11 9/140 (6.43%)  9
Psychiatric disorders         
ANXIETY  1  3/102 (2.94%)  3 7/111 (6.31%)  7 4/142 (2.82%)  5 2/140 (1.43%)  2
INSOMNIA  1  4/102 (3.92%)  4 8/111 (7.21%)  8 4/142 (2.82%)  4 3/140 (2.14%)  3
MOOD SWINGS  1  7/102 (6.86%)  7 7/111 (6.31%)  7 3/142 (2.11%)  3 2/140 (1.43%)  2
Reproductive system and breast disorders         
AMENORRHOEA  1  4/102 (3.92%)  6 14/111 (12.61%)  16 4/142 (2.82%)  4 2/140 (1.43%)  2
Skin and subcutaneous tissue disorders         
ACNE  1  6/102 (5.88%)  6 6/111 (5.41%)  6 5/142 (3.52%)  6 2/140 (1.43%)  2
Vascular disorders         
HOT FLUSH  1  15/102 (14.71%)  16 45/111 (40.54%)  47 7/142 (4.93%)  7 11/140 (7.86%)  11
1
Term from vocabulary, MedDRA (19.1)
Indicates events were collected by systematic assessment
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
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02143713     History of Changes
Other Study ID Numbers: M12-821
2013-001047-31 ( EudraCT Number )
First Submitted: May 19, 2014
First Posted: May 21, 2014
Results First Submitted: August 9, 2018
Results First Posted: September 7, 2018
Last Update Posted: September 7, 2018