Trial · NCT00619866

An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis

NCT00619866, Phase 2, Completed, AbbVie; results first posted 2018-09-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis. Trials, record NCT00619866. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00619866

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Trial

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

Title: An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis
NCT number: NCT00619866
Status: Completed
Phases: Phase 2
Enrollment: 155 participants, actual
Lead sponsor: AbbVie
Conditions: Endometriosis, Pain
Interventions: Elagolix, placebo
First posted: 2008-02-21
Last updated: 2018-09-07
Results first posted: 2018-09-07

Source ClinicalTrials.gov

Registered outcomes26

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12	Baseline and week 12	The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.
Secondary	Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Baseline and weeks 4 and 8	The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly mean NRS is the average of the daily values reported during the 4 weeks prior to each visit.
Secondary	Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain	Baseline and Weeks 4, 8, and 12	The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The monthly peak NRS is the maximum of the daily values reported during the 4 weeks prior to each visit.
Secondary	Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score	Baseline and weeks 4, 8, and 12	Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options: * 0 = No pelvic pain * 1 = Mild pelvic pain; subject could not do some of the things she usually does * 2 = Moderate pelvic pain; subject could not do many of the things she usually does * 3 = Severe pelvic pain; subject could not do most or all of the things she usually does. The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit.
Secondary	Change From Baseline in the Monthly Mean Dysmenorrhea Score	Baseline and Weeks 4, 8, and 12	Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options: * Subject is not having her period * 0 = No pain related to period * 1 = Mild pain related to period; subject could not do some of the things she usually does * 2 = Moderate pain related to period; subject could not do many of the things she usually does * 3 = Severe pain related to period; subject could not do most of or all of the things she usually does. The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit.
Secondary	Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores	Baseline and Weeks 4, 8, and 12	Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) in an e-Diary. The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The monthly mean sum of dysmenorrhea and non-menstrual pelvic pain scores is the average of the daily values reported during the 4 weeks prior to each visit.
Secondary	Percentage of Days With No Pain Based on NRS	Baseline and weeks 4, 8 and 12	The NRS is an 11-point scale used to measure endometriosis pain and was completed at approximately the same time each day using an electronic diary (e-Diary). Participants were instructed to select a single number between 0 (No pain) and 10 (Worst pain ever) that best described their endometriosis pain at its worst over the past day. The percentage of days a participant reported a value of zero (or "no pain") for the NRS was calculated for the 4 weeks prior to each visit.
Secondary	Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment	Baseline and weeks 4, 8 and 12	Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time every day in an e-Diary according to the following response options: * 0 = No pelvic pain * 1 = Mild pelvic pain; subject could not do some of the things she usually does * 2 = Moderate pelvic pain; subject could not do many of the things she usually does * 3 = Severe pelvic pain; subject could not do most or all of the things she usually does. The percentage of days a participant reported a value of zero ("no pain") for non-menstrual pelvic pain was calculated for the 4 weeks prior to each visit.
Secondary	Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment	Baseline and weeks 4, 8 and 12	Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities at approximately the same time each day in an e-Diary according to the following response options: * Subject is not having her period * 0 = No pain related to period * 1 = Mild pain related to period; subject could not do some of the things she usually does * 2 = Moderate pain related to period; subject could not do many of the things she usually does * = Severe pain related to period; subject could not do most of or all of the things she usually does. The percentage of days a participant reported a value of zero ("no pain") for dysmenorrhea was calculated for the 4 weeks prior to each visit.
Secondary	Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment	Baseline and weeks 4, 8 and 12	Participants assessed dysmenorrhea and pelvic pain not related to menses and their impact on daily activities at approximately the same time every day in an e-Diary on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The sum of the dysmenorrhea and non-menstrual pelvic pain scores on each day were calculated to create a daily total score. On days the participant was not having her period, the dysmenorrhea score was not defined; hence, the total score was equal to the non-menstrual pelvic pain score (range 0 to 3). On days where the participant recorded menstruation the total score ranged from 0 to 6, where higher scores indicate more severe pain. The percentage of days a participant reported a value of zero ("no pain") for the non-menstrual pelvic pain and dysmenorrhea total score was calculated for the 4 weeks prior to each visit.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12	Baseline and week 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Baseline and weeks 4 and 8	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain	Baseline and Weeks 4, 8, and 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score	Baseline and weeks 4, 8, and 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Monthly Mean Dysmenorrhea Score	Baseline and Weeks 4, 8, and 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Monthly Mean Total of Dysmenorrhea and Non-menstrual Pelvic Pain Scores	Baseline and Weeks 4, 8, and 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Days With No Pain Based on NRS	Baseline and weeks 4, 8 and 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	percentage of days	MEAN
SECONDARY	Percentage of Days With No Pain Based Based on Non-menstrual Pelvic Pain Daily Assessment	Baseline and weeks 4, 8 and 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	percentage of days	MEAN
SECONDARY	Percentage of Days With No Pain Based Based on Dysmenorrhea Daily Assessment	Baseline and weeks 4, 8 and 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	percentage of days	MEAN
SECONDARY	Percentage of Days With No Pain Based Based on Total Score of Non-menstrual Pelvic Pain and Dysmenorrhea Daily Assessment	Baseline and weeks 4, 8 and 12	All randomized participants who received at least one dose of randomized, double-blind study drug and reported at least 10 e-Diary NRS values during the initial 12 week treatment period. The analysis includes participants with non-missing data at each time point.	percentage of days	MEAN

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group239

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12	Placebo		-0.88	Standard Error 0.18	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12	Elagolix 150 mg		-1.19	Standard Error 0.18	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain at Week 12	Elagolix 250 mg		-1.25	Standard Error 0.18	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Placebo	Week 4	-0.60	Standard Error 0.17	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Elagolix 150 mg	Week 4	-0.90	Standard Error 0.17	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Elagolix 250 mg	Week 4	-0.83	Standard Error 0.17	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Placebo	Week 8	-0.71	Standard Error 0.18	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Elagolix 150 mg	Week 8	-1.23	Standard Error 0.17	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Elagolix 250 mg	Week 8	-0.94	Standard Error 0.17	units on a scale
Change From Baseline in the Monthly Peak Numerical Rating Score (NRS) for Endometriosis Pain	Placebo	Week 4	-1.27	Standard Error 0.32	units on a scale

1 to 10 of 239Source ClinicalTrials.gov

See all 239 results by group

Participant flow30

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

Period	Milestone	Group	Participants
Weeks 1 - 12	STARTED	Placebo	52
Weeks 1 - 12	STARTED	Elagolix 150 mg	51
Weeks 1 - 12	STARTED	Elagolix 250 mg	52
Weeks 1 - 12	STARTED	Placebo / Elagolix 150 mg	0
Weeks 1 - 12	STARTED	Placebo / Elagolix 250 mg	0
Weeks 1 - 12	COMPLETED	Placebo	38
Weeks 1 - 12	COMPLETED	Elagolix 150 mg	45
Weeks 1 - 12	COMPLETED	Elagolix 250 mg	42
Weeks 1 - 12	COMPLETED	Placebo / Elagolix 150 mg	0
Weeks 1 - 12	COMPLETED	Placebo / Elagolix 250 mg	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events39

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	Placebo	1	52	1
other	NAUSEA	Gastrointestinal disorders	Elagolix 150 mg	6	69	7
other	NAUSEA	Gastrointestinal disorders	Elagolix 250 mg	6	72	6
other	NASOPHARYNGITIS	Infections and infestations	Placebo	3	52	3
other	NASOPHARYNGITIS	Infections and infestations	Elagolix 150 mg	2	69	4
other	NASOPHARYNGITIS	Infections and infestations	Elagolix 250 mg	3	72	4
other	SINUSITIS	Infections and infestations	Placebo	2	52	2
other	SINUSITIS	Infections and infestations	Elagolix 150 mg	6	69	6
other	SINUSITIS	Infections and infestations	Elagolix 250 mg	2	72	2
other	UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Placebo	3	52	3

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	52
Total, all-cause mortality	Elagolix 150 mg	0	69
Total, all-cause mortality	Elagolix 250 mg	0	72
Total, other adverse events	Placebo	18	52
Total, other adverse events	Elagolix 150 mg	31	69
Total, other adverse events	Elagolix 250 mg	33	72
Total, serious adverse events	Placebo	0	52
Total, serious adverse events	Elagolix 150 mg	0	69
Total, serious adverse events	Elagolix 250 mg	1	72

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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