Trial · NCT03213457

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

NCT03213457, Phase 3, Completed, AbbVie; results first posted 2021-04-20

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain. Trials, record NCT03213457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03213457

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
NCT number: NCT03213457
Status: Completed
Phases: Phase 3
Enrollment: 681 participants, actual
Lead sponsor: AbbVie
Conditions: Endometriosis
Interventions: Estradiol/Norethindrone Acetate, Placebo for Elagolix, Elagolix, Placebo for E2/NETA
First posted: 2017-07-11
Last updated: 2024-12-20
Results first posted: 2021-04-20

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment	Month 6, Month 12	Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary 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. Pain scores and analgesic use were averaged over 35 days prior to each visit. Response was defined as a reduction of -0.92 or more from baseline in DYS 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).
Primary	Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment	Month 6, Month 12	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary 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. Pain scores and analgesic use were averaged over the 35 days prior to each visit. Response was defined as a reduction of -0.55 or greater from baseline for NMPP 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).
Secondary	Change From Baseline in DYS at Month 12 Based on Daily Assessment	Baseline, Month 12	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary 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. Pain scores were averaged over the 35 days prior to each visit.
Secondary	Change From Baseline in DYS at Month 6 Based on Daily Assessment	Baseline, Month 6	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary 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. Pain scores were averaged over the 35 days prior to each visit.
Secondary	Change From Baseline in DYS at Month 3 Based on Daily Assessment	Baseline, Month 3	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary 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. Pain scores were averaged over the 35 days prior to each visit.
Secondary	Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment	Baseline, Month 12	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary 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. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Secondary	Change From Baseline in NMPP at Month 6 Based on Daily Assessment	Baseline, Month 6	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary 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. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Secondary	Change From Baseline in NMPP at Month 3 Based on Daily Assessment	Baseline, Month 3	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary 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. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Secondary	Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score	Baseline, Month 6	The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.
Secondary	Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment	Baseline, Month 12	Participants assessed DYSP 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.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment	Month 6, Month 12	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only.	percentage of participants	NUMBER
PRIMARY	Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment	Month 6, Month 12	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in DYS at Month 12 Based on Daily Assessment	Baseline, Month 12	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in DYS at Month 6 Based on Daily Assessment	Baseline, Month 6	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in DYS at Month 3 Based on Daily Assessment	Baseline, Month 3	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment	Baseline, Month 12	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in NMPP at Month 6 Based on Daily Assessment	Baseline, Month 6	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in NMPP at Month 3 Based on Daily Assessment	Baseline, Month 3	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score	Baseline, Month 6	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.	T-score	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment	Baseline, Month 12	Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only.	score on a scale	LEAST_SQUARES_MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment	Placebo	Month 6	23.7	95% Confidence Interval 17.64 to 29.73	percentage of participants
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment	Elagolix + E2/NETA	Month 6	62.8	95% Confidence Interval 57.93 to 67.60	percentage of participants
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment	Placebo	Month 12	29.1	95% Confidence Interval 22.62 to 35.58	percentage of participants
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment	Elagolix + E2/NETA	Month 12	63.8	95% Confidence Interval 58.97 to 68.69	percentage of participants
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment	Placebo	Month 6	36.8	95% Confidence Interval 29.98 to 43.70	percentage of participants
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment	Elagolix + E2/NETA	Month 6	51.3	95% Confidence Interval 46.30 to 56.30	percentage of participants
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment	Placebo	Month 12	42.3	95% Confidence Interval 35.28 to 49.37	percentage of participants
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment	Elagolix + E2/NETA	Month 12	54.3	95% Confidence Interval 49.22 to 59.29	percentage of participants
Change From Baseline in DYS at Month 12 Based on Daily Assessment	Placebo		-0.73	Standard Error 0.077	score on a scale
Change From Baseline in DYS at Month 12 Based on Daily Assessment	Elagolix + E2/NETA		-1.73	Standard Error 0.055	score on a scale

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Screening Period	STARTED	Placebo	194
Screening Period	STARTED	Elagolix / Elagolix + E2/NETA	98
Screening Period	STARTED	Elagolix + E2/NETA	389
Screening Period	COMPLETED	Placebo	193
Screening Period	COMPLETED	Elagolix / Elagolix + E2/NETA	97
Screening Period	COMPLETED	Elagolix + E2/NETA	389
Screening Period	NOT COMPLETED	Placebo	1
Screening Period	NOT COMPLETED	Elagolix / Elagolix + E2/NETA	1
Screening Period	NOT COMPLETED	Elagolix + E2/NETA	0
Double-Blind Period	STARTED	Placebo	193

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events840

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	NAUSEA	Gastrointestinal disorders	SCR_Placebo	1	194	1
other	NAUSEA	Gastrointestinal disorders	SCR_Elagolix	0	98	0
other	NAUSEA	Gastrointestinal disorders	SCR_Elagolix_and_E2-NETA	0	389	0
other	NAUSEA	Gastrointestinal disorders	DB_Placebo	12	194	12
other	NAUSEA	Gastrointestinal disorders	DB_Elagolix	16	98	19
other	NAUSEA	Gastrointestinal disorders	DB_Elagolix_and_E2-NETA	51	389	55
other	NAUSEA	Gastrointestinal disorders	OL_Placebo_to_ELA_and_E2-NETA	9	106	11
other	NAUSEA	Gastrointestinal disorders	OL_ELA_to_ELA_and_E2-NETA	2	59	3
other	NAUSEA	Gastrointestinal disorders	OL_ELA_and_E2-NETA_to_ELA_and_E2-NETA	12	215	13
other	NAUSEA	Gastrointestinal disorders	FU_Placebo_to_ELA_and_E2-NETA	0	194	0

1 to 10 of 840Source ClinicalTrials.gov

See all 840 adverse events

Adverse event totals36

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	SCR_Placebo	194
Total, all-cause mortality	SCR_Elagolix	98
Total, all-cause mortality	SCR_Elagolix_and_E2-NETA	389
Total, all-cause mortality	DB_Placebo	194
Total, all-cause mortality	DB_Elagolix	98
Total, all-cause mortality	DB_Elagolix_and_E2-NETA	389
Total, all-cause mortality	OL_Placebo_to_ELA_and_E2-NETA	106
Total, all-cause mortality	OL_ELA_to_ELA_and_E2-NETA	59
Total, all-cause mortality	OL_ELA_and_E2-NETA_to_ELA_and_E2-NETA	215
Total, all-cause mortality	FU_Placebo_to_ELA_and_E2-NETA	194

1 to 10 of 36Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34435897	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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