Trial · NCT00973973
Efficacy and Safety Study of Elagolix in Women With Endometriosis
NCT00973973, Phase 2, Completed, AbbVie; results first posted 2018-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Elagolix in Women With Endometriosis. Trials, record NCT00973973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00973973
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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 in Women With Endometriosis
- NCT number
- NCT00973973
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 137 participants, actual
- Lead sponsor
- AbbVie
- Conditions
- Endometriosis, Pain
- Interventions
- Placebo, Elagolix
- First posted
- 2009-09-09
- Last updated
- 2018-09-26
- Results first posted
- 2018-09-26
Source ClinicalTrials.gov
Registered outcomes28
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 Dysmenorrhea Score During the Double-blind Treatment Phase | Baseline and Weeks 4 and 8 | 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 electronic diary (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. The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit. |
| Primary | Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases | Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment) | 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 electronic diary (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. The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data. |
| Primary | Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Double-Blind Treatment Phase | Baseline and weeks 4 and 8 | Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time each day they were not having 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. The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit. |
| Primary | Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases | Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment) | Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time each day they were not having 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. The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data. |
| Primary | Change From Baseline in the Monthly Mean Cumulative Pain Score During the Double-Blind Treatment Phase | Baseline and weeks 4 and 8 | Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time each day in an e-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. The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) reported during the 4 weeks prior to each visit. |
| Primary | Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases | Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment) | Participants assessed dysmenorrhea or non-menstrual pelvic pain at approximately the same time each day in an e-Diary according to the following: * 0: No discomfort * 1: Mild discomfort, I was easily able to do the things I usually do * 2: Moderate discomfort or pain making it difficult to do some of the things I usually do * 3: Severe pain making it difficult to do the things I usually do The monthly mean cumulative pain score is the average of the daily values for all days (menstrual and non-menstrual) reported during the 4 weeks prior to each visit, except for the week 30 value which is based on 6 weeks of data. |
| Primary | Change From Baseline in the Monthly Mean Dyspareunia Score During the Double-Blind Treatment Phase | Baseline and weeks 4 and 8 | Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options: * 0 = Absent; No discomfort during sexual intercourse * 1 = Mild; I was able to tolerate the discomfort during sexual intercourse * 2 = Moderate; Intercourse was interrupted due to pain * 3 = Severe; I avoided intercourse because of pain * Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each visit. Responses of "does not apply" were not included in the calculations. |
| Primary | Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases | Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment) | Participants assessed their dyspareunia (pain during sexual intercourse) at approximately the same time every day in an e-Diary according to the following response options: * 0: Absent; No discomfort during sexual intercourse * 1: Mild; I was able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; I avoided intercourse because of pain * Does not apply; I was not sexually active for reasons other than my endometriosis or did not have sexual intercourse The monthly mean dyspareunia score is the average of the daily values reported during the 4 weeks prior to each visit, except for week 30 which is based on 6 weeks of data. Responses of "does not apply" were not included in the calculations. |
| Secondary | Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 | Baseline and Week 8 | 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: * 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. The monthly mean dysmenorrhea score is the average of the daily values reported during the 4 weeks prior to each time point. Response was defined as the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%). |
| Secondary | Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 | Baseline and Week 8 | Participants assessed their pelvic pain not related to menses and its impact on their daily activities at approximately the same time each day they were not having 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. The monthly mean non-menstrual pelvic pain score is the average of the daily values reported during the 4 weeks prior to each time point. Response is defined as the percentage of participants with a percent decrease from baseline in the week 8 monthly mean score that was greater than or equal to each specified threshold value (10% through 90% in steps of 10%). |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
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 Dysmenorrhea Score During the Double-blind Treatment Phase | Baseline and Weeks 4 and 8 | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases | Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment) | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Double-Blind Treatment Phase | Baseline and weeks 4 and 8 | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in the Monthly Mean Non-menstrual Pelvic Pain Score During the Open-label and Posttreatment Phases | Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment) | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in the Monthly Mean Cumulative Pain Score During the Double-Blind Treatment Phase | Baseline and weeks 4 and 8 | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population). The analysis includes participants with non-missing data at each time point. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in the Monthly Mean Cumulative Pain Score During the Open-label and Posttreatment Phases | Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment) | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12. The analysis includes participants with non-missing data at each time point. | units on a scale | MEAN |
| PRIMARY | Change From Baseline in the Monthly Mean Dyspareunia Score During the Double-Blind Treatment Phase | Baseline and weeks 4 and 8 | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at each time point. If a participant's responses were all does not apply for that month the score was treated as missing. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in the Monthly Mean Dyspareunia Score During the Open-label and Posttreatment Phases | Baseline and Weeks 12, 16, 20, 24, and 30 (6 weeks posttreatment) | Randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with data on or after Week 12 and non-missing data at each time point. If a participant's responses were all does not apply for that month the score was treated as missing. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Response in Monthly Mean Dysmenorrhea Score at Week 8 | Baseline and Week 8 | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a Response in Monthly Mean Non-menstrual Pelvic Pain Score at Week 8 | Baseline and Week 8 | All randomized participants who received at least 1 dose of study drug and had at least 10 evaluable e-Diary reports during the double-blind period (intent-to-treat population) with non-missing data at baseline and week 8. | percentage of participants | NUMBER |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group272
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 Dysmenorrhea Score During the Double-blind Treatment Phase | Placebo | Week 4 | -0.24 | Standard Error 0.076 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase | Elagolix 150 mg | Week 4 | -0.49 | Standard Error 0.076 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase | Placebo | Week 8 | -0.37 | Standard Error 0.107 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Double-blind Treatment Phase | Elagolix 150 mg | Week 8 | -1.13 | Standard Error 0.107 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases | Placebo | Week 12 | -0.768 | Standard Error 0.118 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases | Elagolix 150 mg | Week 12 | -1.060 | Standard Error 0.130 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases | Placebo | Week 16 | -1.325 | Standard Error 0.112 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases | Elagolix 150 mg | Week 16 | -1.022 | Standard Error 0.137 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases | Placebo | Week 20 | -1.026 | Standard Error 0.119 | units on a scale |
| Change From Baseline in the Monthly Mean Dysmenorrhea Score During the Open-label and Posttreatment Phases | Elagolix 150 mg | Week 20 | -0.991 | Standard Error 0.121 | units on a scale |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Phase (Weeks 1-8) | STARTED | Placebo | 69 | |
| Double-blind Treatment Phase (Weeks 1-8) | STARTED | Elagolix 150 mg | 68 | |
| Double-blind Treatment Phase (Weeks 1-8) | Received Study Drug | Placebo | 69 | |
| Double-blind Treatment Phase (Weeks 1-8) | Received Study Drug | Elagolix 150 mg | 68 | |
| Double-blind Treatment Phase (Weeks 1-8) | COMPLETED | Placebo | 63 | |
| Double-blind Treatment Phase (Weeks 1-8) | COMPLETED | Elagolix 150 mg | 60 | |
| Double-blind Treatment Phase (Weeks 1-8) | NOT COMPLETED | Placebo | 6 | |
| Double-blind Treatment Phase (Weeks 1-8) | NOT COMPLETED | Elagolix 150 mg | 8 | |
| Open-label Treatment Phase (Weeks 8-24) | STARTED | Placebo | 63 | |
| Open-label Treatment Phase (Weeks 8-24) | STARTED | Elagolix 150 mg | 60 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events20
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 | 3 | 69 | 3 |
| other | NAUSEA | Gastrointestinal disorders | Elagolix | 13 | 131 | 13 |
| other | NASOPHARYNGITIS | Infections and infestations | Placebo | 1 | 69 | 1 |
| other | NASOPHARYNGITIS | Infections and infestations | Elagolix | 7 | 131 | 7 |
| other | SINUSITIS | Infections and infestations | Placebo | 5 | 69 | 5 |
| other | SINUSITIS | Infections and infestations | Elagolix | 8 | 131 | 9 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 4 | 69 | 4 |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Elagolix | 8 | 131 | 10 |
| other | HEADACHE | Nervous system disorders | Placebo | 3 | 69 | 3 |
| other | HEADACHE | Nervous system disorders | Elagolix | 13 | 131 | 20 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 69 |
| Total, all-cause mortality | Elagolix | 0 | 131 |
| Total, other adverse events | Placebo | 13 | 69 |
| Total, other adverse events | Elagolix | 49 | 131 |
| Total, serious adverse events | Placebo | 3 | 69 |
| Total, serious adverse events | Elagolix | 1 | 131 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Elagolix vs Placebo: deaths from any cause | Trial comparisons |
| Elagolix vs Placebo: serious adverse events | Trial comparisons |
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.
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/NCT00973973
GET https://conductscience.org/api/trials/v1/NCT00973973/registered?page=2