Trial · NCT00797225

Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis

NCT00797225, Phase 2, Completed, AbbVie; results first posted 2018-09-10

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis. Trials, record NCT00797225. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00797225

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Trial

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

Title: Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis
NCT number: NCT00797225
Status: Completed
Phases: Phase 2
Enrollment: 174 participants, actual
Lead sponsor: AbbVie
Conditions: Endometriosis
Interventions: Leuprorelin Acetate Depot, Elagolix, Placebo to Elagolix, Placebo to Leuprorelin Acetate
First posted: 2008-11-25
Last updated: 2018-09-10
Other registries' IDs: eudract:2007-006474-28
Results first posted: 2018-09-10

Source ClinicalTrials.gov

Registered outcomes24

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	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 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 of their period 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 Sum 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 dysmenorrhea scale included an option for participants who were not having their period. 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	Change From Baseline in the Percentage of Days of Any Analgesic Use	Baseline, Weeks 4, 8 and 12	The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic. The percentage of days of any analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of an analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none").
Secondary	Change From Baseline in the Percentage of Days of Prescription Analgesic Use	Baseline, Weeks 4, 8 and 12	The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic. The percentage of days of prescription analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a prescription analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none").
Secondary	Change From Baseline in the Percentage of Days of Narcotic Analgesic Use	Baseline, Weeks 4, 8 and 12	The daily use of endometriosis analgesics was reported by participants daily using the e-Diary. Participants reported whether the medication was over-the-counter (OTC) or prescription, and, if prescription, whether the medication was a narcotic. The percentage of days of narcotic analgesic use is defined as the number of days in the 4 weeks prior to each study visit that the participant reported the use of a narcotic analgesic, divided by the number of study days in the interval that the participant provided an e-Diary report regarding the use of endometriosis analgesics (including a response of "none").
Secondary	Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)	Baseline and Weeks 4, 8, and 12	The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. To assess dyspareunia (painful intercourse) participants were asked to select the best description of pain during sexual intercourse over the past 28 days using the following response categories: * 0 = Absent; No discomfort during sexual intercourse. * 1 = Mild; I can tolerate the discomfort during sexual intercourse. * 2 = Moderate; Intercourse is sometime interrupted due to pain. * 3 = Severe; I prefer to avoid intercourse because of pain. * Not applicable. I am not sexually active for reasons other than my endometriosis symptoms.
Secondary	Change From Baseline in Dysmenorrhea Component of the CPSSS	Baseline and Week 12	The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. To assess dysmenorrhea (pain during menstruation), participants were asked to select the best description of painful menstruation over the past 28 days using the following response categories: * 0 = Absent; Amenorrhea (no bleeding) or no discomfort. * 1 = Mild; Some loss of work efficiency; occasional use of analgesics. * 2 = Moderate; In bed part of one day, occasional loss of work; regular use of analgesics. * 3 = Severe; In bed ≥ 1 day, incapacitation; requirement for strong analgesics.

1 to 10 of 24Source ClinicalTrials.gov

See all 24 registered outcomes

Outcomes24

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	Baseline and Weeks 4, 8, and 12	All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). 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 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). 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 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). 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 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). 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 Sum of Dysmenorrhea and Non-menstrual Pelvic Pain Scores	Baseline and Weeks 4, 8, and 12	All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). 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 Percentage of Days of Any Analgesic Use	Baseline, Weeks 4, 8 and 12	All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.	percentage of days	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Percentage of Days of Prescription Analgesic Use	Baseline, Weeks 4, 8 and 12	All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.	percentage of days	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Percentage of Days of Narcotic Analgesic Use	Baseline, Weeks 4, 8 and 12	All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at each time point.	percentage of days	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Dyspareunia Component of the Composite Pelvic Signs and Symptoms Score (CPSSS)	Baseline and Weeks 4, 8, and 12	All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). The analysis includes participants with non-missing data at baseline and at each time point.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Dysmenorrhea Component of the CPSSS	Baseline and Week 12	All randomized participants who received at least 1 dose of study drug and had at least 1 evaluable e-Diary report following randomization (intent-to-treat population). Data collection for this endpoint was added via a protocol amendment; therefore, the analysis only includes the subset of participants affected by the protocol amendment.	units on a scale	LEAST_SQUARES_MEAN

1 to 10 of 24Source ClinicalTrials.gov

See all 24 outcomes

Results by group258

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	Placebo	Week 4	-0.35	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	-0.84	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	-1.00	Standard Error 0.17	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Leuprorelin	Week 4	-0.94	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	-0.93	Standard Error 0.20	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Elagolix 150 mg	Week 8	-1.25	Standard Error 0.20	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Elagolix 250 mg	Week 8	-1.57	Standard Error 0.20	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Leuprorelin	Week 8	-1.55	Standard Error 0.20	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Placebo	Week 12	-1.22	Standard Error 0.21	units on a scale
Change From Baseline in the Monthly Mean Numerical Rating Score (NRS) for Endometriosis Pain	Elagolix 150 mg	Week 12	-1.34	Standard Error 0.21	units on a scale

1 to 10 of 258Source ClinicalTrials.gov

See all 258 results by group

Participant flow56

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

Period	Milestone	Group	Participants
Weeks 1 to 12	STARTED	Placebo	43
Weeks 1 to 12	STARTED	Elagolix 150 mg	43
Weeks 1 to 12	STARTED	Elagolix 250 mg	44
Weeks 1 to 12	STARTED	Leuprorelin	44
Weeks 1 to 12	STARTED	Placebo / Elagolix 150 mg	0
Weeks 1 to 12	STARTED	Placebo / Elagolix 250 mg	0
Weeks 1 to 12	STARTED	Leuprorelin / Elagolix 150 mg	0
Weeks 1 to 12	STARTED	Leuprorelin / Elagolix 250 mg	0
Weeks 1 to 12	Received Study Drug	Placebo	43
Weeks 1 to 12	Received Study Drug	Elagolix 150 mg	43

1 to 10 of 56Source ClinicalTrials.gov

See all 56 participant flow

Adverse events28

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	VERTIGO	Ear and labyrinth disorders	Placebo	1	43	1
other	VERTIGO	Ear and labyrinth disorders	Elagolix 150 mg	6	85	6
other	VERTIGO	Ear and labyrinth disorders	Elagolix 250 mg	2	87	2
other	VERTIGO	Ear and labyrinth disorders	Leuprorelin Acetate	0	44	0
other	NAUSEA	Gastrointestinal disorders	Placebo	1	43	1
other	NAUSEA	Gastrointestinal disorders	Elagolix 150 mg	6	85	6
other	NAUSEA	Gastrointestinal disorders	Elagolix 250 mg	5	87	5
other	NAUSEA	Gastrointestinal disorders	Leuprorelin Acetate	0	44	0
other	BONE DENSITY DECREASED	Investigations	Placebo	0	43	0
other	BONE DENSITY DECREASED	Investigations	Elagolix 150 mg	7	85	7

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	43
Total, all-cause mortality	Elagolix 150 mg	0	85
Total, all-cause mortality	Elagolix 250 mg	0	87
Total, all-cause mortality	Leuprorelin Acetate	0	44
Total, other adverse events	Placebo	3	43
Total, other adverse events	Elagolix 150 mg	25	85
Total, other adverse events	Elagolix 250 mg	21	87
Total, other adverse events	Leuprorelin Acetate	6	44
Total, serious adverse events	Placebo	0	43
Total, serious adverse events	Elagolix 150 mg	1	85

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00797225

GET https://conductscience.org/api/trials/v1/NCT00797225/registered?page=2

API reference For AI assistants