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Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain

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ClinicalTrials.gov Identifier: NCT01760954
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : September 6, 2018
Last Update Posted : September 6, 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 506
Recruitment Details

Participants who completed the 6-month Treatment Period in the pivotal Study M12-665 (NCT01620528) were eligible to enter this extension study.

A total of 506 participants were enrolled at 131 sites in the United States, Puerto Rico, and Canada. Two enrolled participants did not receive study drug and are not included in the tables reported below.

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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667. Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667. Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667. Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Period Title: Treatment Period (6 Months)
Started 149 138 108 109
Completed 116 110 87 83
Not Completed 33 28 21 26
Reason Not Completed
Withdrawal by Subject             8             8             4             5
Adverse Event             5             3             4             10
Lost to Follow-up             9             1             4             3
Surgery or invasive intervention for end             3             3             3             2
Pregnancy             5             0             3             2
Non-compliance             1             4             0             3
Other             0             3             3             1
Decrease in Bone Mineral Density (BMD)             1             6             0             0
Exclusionary Medication             1             0             0             0
Period Title: Post-treatment Follow-up (12 Months)
Started [1] 126 118 86 87
Completed 96 83 65 67
Not Completed 30 35 21 20
Reason Not Completed
Withdrawal by Subject             6             6             4             9
Lost to Follow-up             4             7             2             0
Surgery or invasive intervention             6             10             5             5
Received Exclusionary Medication             1             4             0             0
Return of Menses and Acceptable BMD             0             0             1             0
Other             13             8             9             6
[1]
Participants who completed the 6-month Treatment Period or prematurely discontinued could enter PTFU
Arm/Group Title Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID Total
Hide Arm/Group Description Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667. Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667. Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667. Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667. Total of all reporting groups
Overall Number of Baseline Participants 149 138 108 109 504
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants 138 participants 108 participants 109 participants 504 participants
31.8  (6.52) 31.3  (6.32) 32.4  (6.08) 32.2  (6.38) 31.9  (6.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 138 participants 108 participants 109 participants 504 participants
Female
149
 100.0%
138
 100.0%
108
 100.0%
109
 100.0%
504
 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 149 participants 138 participants 108 participants 109 participants 504 participants
Hispanic or Latino
23
  15.4%
21
  15.2%
19
  17.6%
22
  20.2%
85
  16.9%
Not Hispanic or Latino
126
  84.6%
117
  84.8%
89
  82.4%
87
  79.8%
419
  83.1%
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 149 participants 138 participants 108 participants 109 participants 504 participants
White
133
  89.3%
126
  91.3%
96
  88.9%
95
  87.2%
450
  89.3%
Black or African American
12
   8.1%
9
   6.5%
8
   7.4%
12
  11.0%
41
   8.1%
Asian
2
   1.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.4%
American Indian/Alaska Native
1
   0.7%
0
   0.0%
1
   0.9%
0
   0.0%
2
   0.4%
Multi race
1
   0.7%
3
   2.2%
3
   2.8%
1
   0.9%
8
   1.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.9%
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 –0.81 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 M12-665.

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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 117 110 86 87
Measure Type: Number
Unit of Measure: percentage of participants
52.1 78.2 32.6 64.4
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 −0.36 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 M12-665.

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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 117 110 86 87
Measure Type: Number
Unit of Measure: percentage of participants
67.5 69.1 39.5 57.5
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 –0.81 or more from baseline in dysmenorrhea 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 analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665.

Participants recorded rescue analgesic medication for endometriosis-associated pain daily and dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an 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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 108 109
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 148 participants 136 participants 105 participants 107 participants
48.0 80.9 21.0 20.6
Month 2 Number Analyzed 139 participants 128 participants 97 participants 100 participants
51.1 78.9 40.2 60.0
Month 3 Number Analyzed 132 participants 123 participants 95 participants 94 participants
49.2 80.5 36.8 54.3
Month 4 Number Analyzed 128 participants 119 participants 91 participants 91 participants
53.9 79.8 39.6 58.2
Month 5 Number Analyzed 124 participants 114 participants 89 participants 89 participants
54.0 83.3 32.6 64.0
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 −0.36 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 M12-665.

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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 108 109
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 148 participants 136 participants 105 participants 107 participants
55.4 74.3 23.8 29.0
Month 2 Number Analyzed 139 participants 128 participants 97 participants 100 participants
62.6 69.5 38.1 41.0
Month 3 Number Analyzed 132 participants 123 participants 95 participants 94 participants
61.4 70.7 33.7 45.7
Month 4 Number Analyzed 128 participants 119 participants 91 participants 91 participants
64.1 75.6 39.6 47.3
Month 5 Number Analyzed 124 participants 114 participants 89 participants 89 participants
61.3 71.9 40.4 51.7
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 −0.36 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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 108 109
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 106 participants 93 participants 72 participants 77 participants
50.0 61.3 33.3 15.6
Month 2 Number Analyzed 104 participants 84 participants 67 participants 70 participants
51.9 58.3 35.8 30.0
Month 3 Number Analyzed 98 participants 80 participants 66 participants 64 participants
50.0 63.8 36.4 32.8
Month 4 Number Analyzed 92 participants 75 participants 64 participants 62 participants
48.9 65.3 46.9 41.9
Month 5 Number Analyzed 88 participants 75 participants 63 participants 58 participants
46.6 65.3 38.1 39.7
Month 6 Number Analyzed 84 participants 70 participants 59 participants 58 participants
45.2 60.0 39.0 43.1
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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 107 107
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 Number Analyzed 148 participants 136 participants 96 participants 101 participants
-46.7  (44.00) -82.7  (34.81) -19.0  (50.35) -19.3  (51.09)
Month 2 Number Analyzed 139 participants 128 participants 89 participants 95 participants
-46.7  (44.93) -84.8  (29.81) -46.6  (47.39) -67.3  (47.74)
Month 3 Number Analyzed 132 participants 123 participants 88 participants 89 participants
-47.9  (42.37) -84.5  (33.24) -36.3  (57.28) -65.9  (47.17)
Month 4 Number Analyzed 128 participants 119 participants 85 participants 87 participants
-51.4  (44.65) -85.1  (30.52) -38.2  (52.48) -67.4  (47.80)
Month 5 Number Analyzed 124 participants 114 participants 84 participants 85 participants
-52.4  (43.55) -83.4  (31.19) -33.4  (48.29) -77.2  (41.90)
Month 6 Number Analyzed 117 participants 110 participants 81 participants 83 participants
-49.2  (43.75) -82.0  (33.29) -37.9  (47.43) -71.6  (47.81)
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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 107 107
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 Number Analyzed 148 participants 136 participants 103 participants 104 participants
-37.4  (43.90) -54.5  (40.35) -9.6  (104.61) -20.7  (51.24)
Month 2 Number Analyzed 139 participants 128 participants 96 participants 97 participants
-41.4  (41.49) -56.4  (38.54) -22.6  (85.60) -18.0  (98.73)
Month 3 Number Analyzed 132 participants 123 participants 94 participants 91 participants
-44.0  (40.44) -56.8  (39.14) -19.7  (93.18) -30.2  (57.07)
Month 4 Number Analyzed 128 participants 119 participants 90 participants 89 participants
-47.2  (41.30) -59.6  (37.30) -32.0  (66.23) -33.9  (53.27)
Month 5 Number Analyzed 124 participants 114 participants 89 participants 87 participants
-45.3  (41.05) -58.0  (39.18) -17.7  (126.45) -42.5  (43.01)
Month 6 Number Analyzed 117 participants 110 participants 86 participants 85 participants
-48.9  (41.69) -56.5  (40.15) -10.2  (163.42) -43.9  (43.57)
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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 123 109 85 82
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 Number Analyzed 98 participants 89 participants 66 participants 72 participants
-32.8  (63.13) -39.5  (71.30) -12.9  (62.92) -1.1  (63.74)
Month 2 Number Analyzed 98 participants 80 participants 61 participants 66 participants
-36.2  (56.97) -40.4  (63.27) -16.2  (82.49) -27.1  (48.17)
Month 3 Number Analyzed 93 participants 77 participants 60 participants 60 participants
-36.1  (55.41) -38.6  (75.34) -14.1  (76.54) -23.5  (50.71)
Month 4 Number Analyzed 86 participants 72 participants 58 participants 58 participants
-35.0  (55.27) -48.6  (63.81) -24.3  (76.26) -20.7  (71.89)
Month 5 Number Analyzed 83 participants 72 participants 57 participants 55 participants
-34.9  (58.90) -44.8  (76.01) -20.2  (62.92) -27.5  (58.78)
Month 6 Number Analyzed 79 participants 69 participants 53 participants 56 participants
-30.7  (66.57) -41.7  (68.50) -28.0  (66.59) -12.6  (107.83)
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, and/or codeine 30 mg + acetaminophen 300 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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 107 107
Mean (Standard Deviation)
Unit of Measure: pills/day
Month 1 Number Analyzed 148 participants 136 participants 105 participants 107 participants
-0.35  (0.743) -0.58  (0.687) -0.15  (0.398) -0.16  (0.486)
Month 2 Number Analyzed 139 participants 128 participants 97 participants 100 participants
-0.35  (0.646) -0.59  (0.735) -0.24  (0.471) -0.28  (0.481)
Month 3 Number Analyzed 132 participants 123 participants 95 participants 94 participants
-0.37  (0.733) -0.61  (0.785) -0.25  (0.525) -0.32  (0.470)
Month 4 Number Analyzed 128 participants 119 participants 91 participants 91 participants
-0.40  (0.703) -0.62  (0.697) -0.26  (0.521) -0.35  (0.616)
Month 5 Number Analyzed 124 participants 114 participants 89 participants 89 participants
-0.41  (0.687) -0.59  (0.685) -0.27  (0.626) -0.34  (0.590)
Month 6 Number Analyzed 117 participants 110 participants 86 participants 87 participants
-0.40  (0.699) -0.56  (0.667) -0.22  (0.616) -0.38  (0.602)
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, and/or codeine 30 mg + acetaminophen 300 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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 107 107
Mean (Standard Deviation)
Unit of Measure: pills/day
Month 1 Number Analyzed 148 participants 136 participants 105 participants 107 participants
-0.24  (0.484) -0.34  (0.469) -0.07  (0.217) -0.09  (0.314)
Month 2 Number Analyzed 139 participants 128 participants 97 participants 100 participants
-0.24  (0.472) -0.34  (0.462) -0.12  (0.302) -0.14  (0.311)
Month 3 Number Analyzed 132 participants 123 participants 95 participants 94 participants
-0.24  (0.488) -0.34  (0.460) -0.12  (0.324) -0.14  (0.346)
Month 4 Number Analyzed 128 participants 119 participants 91 participants 91 participants
-0.25  (0.461) -0.35  (0.450) -0.13  (0.336) -0.17  (0.397)
Month 5 Number Analyzed 124 participants 114 participants 89 participants 89 participants
-0.27  (0.494) -0.32  (0.417) -0.13  (0.378) -0.17  (0.394)
Month 6 Number Analyzed 117 participants 110 participants 86 participants 87 participants
-0.27  (0.517) -0.31  (0.430) -0.12  (0.380) -0.23  (0.453)
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, and/or codeine 30 mg + acetaminophen 300 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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 107 107
Mean (Standard Deviation)
Unit of Measure: pills/day
Month 1 Number Analyzed 148 participants 136 participants 105 participants 107 participants
-0.11  (0.547) -0.24  (0.469) -0.09  (0.272) -0.07  (0.329)
Month 2 Number Analyzed 139 participants 128 participants 97 participants 100 participants
-0.11  (0.441) -0.25  (0.532) -0.12  (0.267) -0.14  (0.344)
Month 3 Number Analyzed 132 participants 123 participants 95 participants 94 participants
-0.13  (0.540) -0.28  (0.599) -0.13  (0.298) -0.17  (0.338)
Month 4 Number Analyzed 128 participants 119 participants 91 participants 91 participants
-0.15  (0.541) -0.27  (0.581) -0.13  (0.298) -0.19  (0.501)
Month 5 Number Analyzed 124 participants 114 participants 89 participants 89 participants
-0.15  (0.469) -0.27  (0.558) -0.14  (0.384) -0.17  (0.444)
Month 6 Number Analyzed 117 participants 110 participants 86 participants 87 participants
-0.13  (0.439) -0.25  (0.534) -0.10  (0.369) -0.16  (0.392)
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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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.
Arm/Group Title Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 107 107
Mean (Standard Deviation)
Unit of Measure: percent change
Month 1 Number Analyzed 148 participants 136 participants 104 participants 107 participants
-41.0  (39.85) -60.0  (36.93) -9.2  (81.63) -22.3  (34.41)
Month 2 Number Analyzed 139 participants 128 participants 96 participants 100 participants
-44.4  (38.35) -62.1  (33.80) -31.2  (39.22) -34.6  (41.07)
Month 3 Number Analyzed 132 participants 123 participants 94 participants 94 participants
-45.5  (36.23) -62.2  (34.10) -28.0  (55.94) -39.9  (41.48)
Month 4 Number Analyzed 128 participants 119 participants 90 participants 91 participants
-47.7  (37.99) -63.5  (32.93) -32.8  (57.74) -40.0  (54.65)
Month 5 Number Analyzed 124 participants 114 participants 89 participants 89 participants
-46.4  (38.07) -62.1  (34.56) -29.0  (71.65) -46.4  (39.07)
Month 6 Number Analyzed 117 participants 110 participants 86 participants 87 participants
-48.2  (38.97) -60.7  (36.09) -27.8  (64.75) -45.5  (44.10)
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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 148 108 109
Measure Type: Number
Unit of Measure: percentage of participants
Month 1 Number Analyzed 139 participants 132 participants 102 participants 101 participants
63.3 86.4 47.1 45.5
Month 2 Number Analyzed 136 participants 126 participants 99 participants 100 participants
64.7 87.3 65.7 70.0
Month 3 Number Analyzed 129 participants 119 participants 95 participants 94 participants
64.3 87.4 73.7 71.3
Month 4 Number Analyzed 123 participants 118 participants 92 participants 89 participants
70.7 91.5 73.9 70.8
Month 5 Number Analyzed 121 participants 112 participants 86 participants 89 participants
75.2 87.5 66.3 78.7
Month 6 Number Analyzed 111 participants 102 participants 81 participants 82 participants
69.4 91.2 70.4 79.3
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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 135 108 109
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 Number Analyzed 138 participants 127 participants 101 participants 100 participants
-29.50  (20.917) -40.28  (21.503) -12.98  (17.426) -13.27  (17.010)
Month 3 Number Analyzed 132 participants 120 participants 94 participants 95 participants
-30.10  (20.231) -43.16  (20.951) -17.87  (21.160) -21.87  (24.087)
Month 6 Number Analyzed 107 participants 99 participants 72 participants 80 participants
-31.18  (22.213) -41.62  (21.553) -15.63  (22.676) -25.17  (23.387)
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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 120 102 97 95
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 1 Number Analyzed 105 participants 86 participants 73 participants 71 participants
-19.81  (23.828) -29.42  (28.257) -8.15  (21.287) -9.86  (17.484)
Month 3 Number Analyzed 97 participants 77 participants 72 participants 68 participants
-20.88  (24.979) -27.27  (30.431) -15.00  (22.890) -18.24  (23.015)
Month 6 Number Analyzed 78 participants 64 participants 51 participants 52 participants
-24.23  (27.065) -30.55  (33.831) -12.45  (26.858) -23.17  (25.763)
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 M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 140 135 102 106
Mean (Standard Deviation)
Unit of Measure: hours
Absenteeism from workplace Number Analyzed 76 participants 72 participants 48 participants 60 participants
-1.84  (5.636) -3.01  (6.771) -2.15  (4.258) -2.78  (4.730)
Presenteeism from workplace Number Analyzed 76 participants 69 participants 48 participants 59 participants
-11.14  (8.484) -12.45  (10.464) -8.29  (8.307) -10.15  (10.724)
Total hours of work lost from workplace Number Analyzed 76 participants 72 participants 48 participants 60 participants
-12.98  (9.662) -15.15  (11.653) -10.44  (9.422) -13.03  (11.911)
Absenteeism from household Number Analyzed 90 participants 91 participants 63 participants 70 participants
-3.10  (7.588) -3.69  (4.486) -3.76  (7.457) -2.80  (4.971)
Presenteeism from household Number Analyzed 90 participants 90 participants 62 participants 70 participants
-2.72  (6.459) -2.49  (4.531) -2.95  (4.793) -2.72  (4.698)
Total hours of work lost from household Number Analyzed 90 participants 91 participants 63 participants 70 participants
-5.82  (11.356) -6.15  (7.628) -6.90  (11.673) -5.52  (6.934)
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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 149 138 108 109
Measure Type: Count of Participants
Unit of Measure: Participants
81
  54.4%
68
  49.3%
59
  54.6%
48
  44.0%
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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description:
Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667.
Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
Overall Number of Participants Analyzed 7 6 5 4
Median (Full Range)
Unit of Measure: days
2.0
(1 to 6)
1.5
(1 to 4)
3.0
(2 to 8)
1.0
(1 to 2)
Time Frame From the date of the first dose of study drug in Study M12-667 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 Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Hide Arm/Group Description Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667. Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667. Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667. Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667.
All-Cause Mortality
Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/149 (0.00%)      0/138 (0.00%)      0/108 (0.00%)      0/109 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/149 (3.36%)      4/138 (2.90%)      5/108 (4.63%)      5/109 (4.59%)    
Cardiac disorders         
SUPRAVENTRICULAR TACHYCARDIA  1  0/149 (0.00%)  0 0/138 (0.00%)  0 1/108 (0.93%)  1 0/109 (0.00%)  0
Gastrointestinal disorders         
ABDOMINAL PAIN UPPER  1  1/149 (0.67%)  1 0/138 (0.00%)  0 0/108 (0.00%)  0 0/109 (0.00%)  0
COLITIS  1  0/149 (0.00%)  0 0/138 (0.00%)  0 1/108 (0.93%)  1 0/109 (0.00%)  0
GASTROINTESTINAL HAEMORRHAGE  1  1/149 (0.67%)  1 0/138 (0.00%)  0 0/108 (0.00%)  0 0/109 (0.00%)  0
INCARCERATED UMBILICAL HERNIA  1  0/149 (0.00%)  0 0/138 (0.00%)  0 1/108 (0.93%)  1 0/109 (0.00%)  0
NAUSEA  1  0/149 (0.00%)  0 0/138 (0.00%)  0 0/108 (0.00%)  0 1/109 (0.92%)  1
VOMITING  1  0/149 (0.00%)  0 0/138 (0.00%)  0 0/108 (0.00%)  0 1/109 (0.92%)  1
Hepatobiliary disorders         
CHOLELITHIASIS  1  0/149 (0.00%)  0 0/138 (0.00%)  0 0/108 (0.00%)  0 1/109 (0.92%)  1
Infections and infestations         
DIVERTICULITIS  1  1/149 (0.67%)  1 0/138 (0.00%)  0 0/108 (0.00%)  0 0/109 (0.00%)  0
Injury, poisoning and procedural complications         
JOINT INJURY  1  1/149 (0.67%)  1 0/138 (0.00%)  0 0/108 (0.00%)  0 0/109 (0.00%)  0
Musculoskeletal and connective tissue disorders         
INTERVERTEBRAL DISC PROTRUSION  1  1/149 (0.67%)  1 0/138 (0.00%)  0 0/108 (0.00%)  0 0/109 (0.00%)  0
NECK PAIN  1  0/149 (0.00%)  0 1/138 (0.72%)  1 0/108 (0.00%)  0 0/109 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
LUNG ADENOCARCINOMA  1  0/149 (0.00%)  0 0/138 (0.00%)  0 1/108 (0.93%)  1 0/109 (0.00%)  0
Nervous system disorders         
MIGRAINE  1  0/149 (0.00%)  0 1/138 (0.72%)  1 0/108 (0.00%)  0 0/109 (0.00%)  0
Pregnancy, puerperium and perinatal conditions         
ABORTION SPONTANEOUS  1  0/149 (0.00%)  0 0/138 (0.00%)  0 0/108 (0.00%)  0 1/109 (0.92%)  1
Psychiatric disorders         
AFFECTIVE DISORDER  1  0/149 (0.00%)  0 1/138 (0.72%)  1 0/108 (0.00%)  0 0/109 (0.00%)  0
SUICIDAL IDEATION  1  1/149 (0.67%)  1 0/138 (0.00%)  0 0/108 (0.00%)  0 0/109 (0.00%)  0
Reproductive system and breast disorders         
OVARIAN CYST  1  0/149 (0.00%)  0 0/138 (0.00%)  0 1/108 (0.93%)  1 0/109 (0.00%)  0
PELVIC PAIN  1  0/149 (0.00%)  0 2/138 (1.45%)  2 0/108 (0.00%)  0 2/109 (1.83%)  2
PREMENSTRUAL DYSPHORIC DISORDER  1  1/149 (0.67%)  1 0/138 (0.00%)  0 0/108 (0.00%)  0 0/109 (0.00%)  0
Surgical and medical procedures         
ABORTION INDUCED  1  0/149 (0.00%)  0 0/138 (0.00%)  0 1/108 (0.93%)  1 1/109 (0.92%)  1
1
Term from vocabulary, MedDRA (18.1)
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%
Elagolix/Elagolix 150 mg QD Elagolix/Elagolix 200 mg BID Placebo/Elagolix 150 mg QD Placebo/Elagolix 200 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   79/149 (53.02%)      74/138 (53.62%)      55/108 (50.93%)      68/109 (62.39%)    
Gastrointestinal disorders         
ABDOMINAL PAIN  1  7/149 (4.70%)  7 8/138 (5.80%)  9 2/108 (1.85%)  3 1/109 (0.92%)  1
NAUSEA  1  7/149 (4.70%)  8 10/138 (7.25%)  12 6/108 (5.56%)  6 11/109 (10.09%)  12
General disorders         
FATIGUE  1  9/149 (6.04%)  9 5/138 (3.62%)  5 3/108 (2.78%)  3 4/109 (3.67%)  4
Infections and infestations         
BRONCHITIS  1  8/149 (5.37%)  8 7/138 (5.07%)  7 3/108 (2.78%)  3 3/109 (2.75%)  3
INFLUENZA  1  6/149 (4.03%)  6 6/138 (4.35%)  7 7/108 (6.48%)  7 1/109 (0.92%)  1
NASOPHARYNGITIS  1  9/149 (6.04%)  9 9/138 (6.52%)  11 5/108 (4.63%)  5 3/109 (2.75%)  3
SINUSITIS  1  10/149 (6.71%)  10 10/138 (7.25%)  11 6/108 (5.56%)  6 10/109 (9.17%)  10
UPPER RESPIRATORY TRACT INFECTION  1  16/149 (10.74%)  18 4/138 (2.90%)  4 5/108 (4.63%)  5 5/109 (4.59%)  5
URINARY TRACT INFECTION  1  17/149 (11.41%)  23 11/138 (7.97%)  12 10/108 (9.26%)  10 8/109 (7.34%)  9
VULVOVAGINAL MYCOTIC INFECTION  1  8/149 (5.37%)  10 6/138 (4.35%)  6 6/108 (5.56%)  7 3/109 (2.75%)  5
Investigations         
BONE DENSITY DECREASED  1  2/149 (1.34%)  2 9/138 (6.52%)  9 2/108 (1.85%)  2 3/109 (2.75%)  3
C-REACTIVE PROTEIN INCREASED  1  3/149 (2.01%)  3 7/138 (5.07%)  7 3/108 (2.78%)  4 3/109 (2.75%)  4
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  2/149 (1.34%)  2 7/138 (5.07%)  7 2/108 (1.85%)  2 4/109 (3.67%)  5
BACK PAIN  1  6/149 (4.03%)  7 10/138 (7.25%)  11 3/108 (2.78%)  3 5/109 (4.59%)  5
Nervous system disorders         
HEADACHE  1  10/149 (6.71%)  11 8/138 (5.80%)  11 10/108 (9.26%)  13 15/109 (13.76%)  20
Psychiatric disorders         
ANXIETY  1  5/149 (3.36%)  5 2/138 (1.45%)  2 6/108 (5.56%)  6 3/109 (2.75%)  4
DEPRESSION  1  8/149 (5.37%)  8 4/138 (2.90%)  4 2/108 (1.85%)  2 0/109 (0.00%)  0
INSOMNIA  1  5/149 (3.36%)  5 5/138 (3.62%)  6 1/108 (0.93%)  1 6/109 (5.50%)  7
Vascular disorders         
HOT FLUSH  1  6/149 (4.03%)  7 8/138 (5.80%)  8 18/108 (16.67%)  19 33/109 (30.28%)  38
1
Term from vocabulary, MedDRA (18.1)
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: NCT01760954     History of Changes
Other Study ID Numbers: M12-667
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: August 9, 2018
Results First Posted: September 6, 2018
Last Update Posted: September 6, 2018