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A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.
This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elagolix 150 mg QD | Experimental | Elagolix 150 mg once daily (QD) for the 6-month Treatment Period |
|
| Elagolix 200 mg BID | Experimental | Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period |
|
| Placebo | Placebo Comparator | Placebo BID for the 6-month Treatment Period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elagolix | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 3 of the Treatment Period |
| Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 3 of Treatment Period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | Baseline, Month 3 of the Treatment Period |
| Change From Baseline to Month 6 in DYS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Duan, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28525302 | Result | Taylor HS, Giudice LC, Lessey BA, Abrao MS, Kotarski J, Archer DF, Diamond MP, Surrey E, Johnson NP, Watts NB, Gallagher JC, Simon JA, Carr BR, Dmowski WP, Leyland N, Rowan JP, Duan WR, Ng J, Schwefel B, Thomas JW, Jain RI, Chwalisz K. Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH Antagonist. N Engl J Med. 2017 Jul 6;377(1):28-40. doi: 10.1056/NEJMoa1700089. Epub 2017 May 19. | |
| 34878624 |
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Participants who prematurely discontinued from study drug and those who declined to participate in or who did not qualify for the continuous-use extension study, except for those who became pregnant, could elect to enter the Post-Treatment Follow-Up (PTFU) Period within this study for up to 12 additional months.
After completing the Treatment Period, participants (who were eligible and provided consent) entered a separate continuous-use extension study (Study M12-667, NCT01760954).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo twice daily (BID) for the 6-month Treatment Period |
| FG001 | Elagolix 150 mg QD | Elagolix 150 mg once daily (QD) for the 6-month Treatment Period |
| FG002 | Elagolix 200 mg BID | Elagolix 200 mg BID for the 6-month Treatment Period |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
|
| |||||||||||||||||||||
| Post-Treatment Follow-Up Period |
|
All participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo BID for the 6-month Treatment Period |
| BG001 | Elagolix 150 mg QD | Elagolix 150 mg QD for the 6-month Treatment Period |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS) | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The modified intent-to-treat (mITT) analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward. | Posted | Number | percentage of participants | At Month 3 of the Treatment Period |
|
From first dose of study treatment through 6 months of treatment plus up to 12 months of follow-up.
Adverse events (AEs) are defined as treatment-emergent if they began on or after the date of the first dose of study drug through up to 30 days after the last dose of study drug for participants who did not enroll in the separate extension study (Study M12-667, NCT01760954). For participants who enrolled in the separate extension study, treatment-emergent AEs are those that began on or after the first dose of study drug until the day prior to the first dose date in the extension study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo BID for the 6-month Treatment Period |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C539351 | elagolix |
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| placebo | Other | oral tablet |
|
The DYS pain scale ranges from 0 (none) to 3 (severe).
| Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 6 in NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 3 in Dyspareunia (DYSP) | The DYSP pain scale ranges from 0 (absent) to 3 (severe). | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | Baseline, Month 3 of Treatment Period |
| Percentage of Responders at Month 1 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 1 of the Treatment Period |
| Percentage of Responders at Month 2 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 2 of the Treatment Period |
| Percentage of Responders at Month 4 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 4 of the Treatment Period |
| Percentage of Responders at Month 5 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 5 of the Treatment Period |
| Percentage of Responders at Month 6 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 6 of the Treatment Period |
| Percentage of Responders at Month 1 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 1 of Treatment Period |
| Percentage of Responders at Month 2 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 2 of Treatment Period |
| Percentage of Responders at Month 4 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 4 of Treatment Period |
| Percentage of Responders at Month 5 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 5 of Treatment Period |
| Percentage of Responders at Month 6 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 6 of Treatment Period |
| Percentage of Responders at Month 1 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 1 of the Treatment Period |
| Percentage of Responders at Month 2 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 2 of the Treatment Period |
| Percentage of Responders at Month 4 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 4 of the Treatment Period |
| Percentage of Responders at Month 5 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 5 of the Treatment Period |
| Percentage of Responders at Month 6 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | At Month 6 of the Treatment Period |
| Change From Baseline to Month 1 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 3 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 4 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 5 of Treatment Period |
| Percent Change From Baseline to Month 1 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 1 of Treatment Period |
| Percent Change From Baseline to Month 2 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 2 of Treatment Period |
| Percent Change From Baseline to Month 3 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 3 of Treatment Period |
| Percent Change From Baseline to Month 4 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 4 of Treatment Period |
| Percent Change From Baseline to Month 5 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 5 of Treatment Period |
| Percent Change From Baseline to Month 6 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 3 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 4 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 5 of Treatment Period |
| Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 1 of Treatment Period |
| Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 2 of Treatment Period |
| Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 3 of Treatment Period |
| Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 4 of Treatment Period |
| Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 5 of Treatment Period |
| Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 4 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | Baseline, Month 5 of Treatment Period |
| Change From Baseline to Month 6 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | Baseline, Month 5 of Treatment Period |
| Response to Patient Global Impression of Change (PGIC) at Month 1 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | Month 1 of Treatment Period |
| Response to PGIC at Month 2 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | Month 2 of Treatment Period |
| Response to PGIC at Month 3 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | Month 3 of Treatment Period |
| Response to PGIC at Month 4 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | Month 4 of Treatment Period |
| Response to PGIC at Month 5 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | Month 5 of Treatment Period |
| Response to PGIC at Month 6 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | Month 6 of Treatment Period |
| Change From Baseline to Month 1 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 4 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | Baseline, Month 5 of Treatment Period |
| Change From Baseline to Month 6 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 3 in the Pain Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 6 in the Pain Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 5 of Treatment Period |
| Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 5 of Treatment Period |
| Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 5 of Treatment Period |
| Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 5 of Treatment Period |
| Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 5 of Treatment Period |
| Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 6 of Treatment Period |
| Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 1 of Treatment Period |
| Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 2 of Treatment Period |
| Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 3 of Treatment Period |
| Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 4 of Treatment Period |
| Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 5 of Treatment Period |
| Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | Baseline, Month 6 of Treatment Period |
| Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | Up to Month 6 of Treatment Period |
| Number of Days of Hospitalization | Up to Month 6 of Treatment Period |
| Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | Up to Month 6 of Treatment Period |
| Derived |
| Beck D, Winzenborg I, Liu M, Degner J, Mostafa NM, Noertersheuser P, Shebley M. Population Pharmacokinetics of Elagolix in Combination with Low-Dose Estradiol/Norethindrone Acetate in Women with Uterine Fibroids. Clin Pharmacokinet. 2022 Apr;61(4):577-587. doi: 10.1007/s40262-021-01096-w. Epub 2021 Dec 8. |
| 34134684 | Derived | Abrao MS, Surrey E, Gordon K, Snabes MC, Wang H, Ijacu H, Taylor HS. Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patients. BMC Womens Health. 2021 Jun 16;21(1):246. doi: 10.1186/s12905-021-01385-3. |
| 33963686 | Derived | Stodtmann S, Nader A, Polepally AR, Suleiman AA, Winzenborg I, Noertersheuser P, Ng J, Mostafa NM, Shebley M. Validation of a quantitative systems pharmacology model of calcium homeostasis using elagolix Phase 3 clinical trial data in women with endometriosis. Clin Transl Sci. 2021 Jul;14(4):1611-1619. doi: 10.1111/cts.13040. Epub 2021 May 7. |
| 33650259 | Derived | Beck D, Winzenborg I, Gao W, Mostafa NM, Noertersheuser P, Chiuve SE, Owens C, Shebley M. Integrating real-world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women. Clin Transl Sci. 2021 Jul;14(4):1452-1463. doi: 10.1111/cts.13006. Epub 2021 Apr 8. |
| 33564263 | Derived | Agarwal SK, Singh SS, Archer DF, Mai Y, Chwalisz K, Gordon K, Surrey E. Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix. J Pain Res. 2021 Feb 2;14:263-271. doi: 10.2147/JPR.S284703. eCollection 2021. |
| 33066973 | Derived | Pokrzywinski RM, Soliman AM, Snabes MC, Chen J, Taylor HS, Coyne KS. Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis. Fertil Steril. 2021 Feb;115(2):423-430. doi: 10.1016/j.fertnstert.2020.07.013. Epub 2020 Oct 14. |
| 32945631 | Derived | Abbas Suleiman A, Nader A, Winzenborg I, Beck D, Polepally AR, Ng J, Noertersheuser P, Mostafa NM. Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated Pain. CPT Pharmacometrics Syst Pharmacol. 2020 Nov;9(11):639-648. doi: 10.1002/psp4.12560. Epub 2020 Oct 8. |
| 32769633 | Derived | Taylor HS, Soliman AM, Johns B, Pokrzywinski RM, Snabes M, Coyne KS. Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix. Obstet Gynecol. 2020 Sep;136(3):501-509. doi: 10.1097/AOG.0000000000003917. |
| 32621325 | Derived | Winzenborg I, Polepally AR, Nader A, Mostafa NM, Noertersheuser P, Ng J. Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis-Associated Pain: An Application of Markov Model. CPT Pharmacometrics Syst Pharmacol. 2020 Aug;9(8):466-475. doi: 10.1002/psp4.12545. Epub 2020 Jul 31. |
| 31654294 | Derived | Surrey ES, Soliman AM, Palac HL, Agarwal SK. Impact of Elagolix on Workplace and Household Productivity Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials. Patient. 2019 Dec;12(6):651-660. doi: 10.1007/s40271-019-00394-7. |
| 31227284 | Derived | Pokrzywinski RM, Soliman AM, Chen J, Snabes M, Diamond MP, Surrey E, Coyne KS. Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials. Fertil Steril. 2019 Sep;112(3):545-551. doi: 10.1016/j.fertnstert.2019.04.031. Epub 2019 Jun 18. |
| 30992150 | Derived | Surrey ES, Soliman AM, Agarwal SK, Snabes MC, Diamond MP. Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosis. Fertil Steril. 2019 Aug;112(2):298-304.e3. doi: 10.1016/j.fertnstert.2019.02.031. Epub 2019 Apr 13. |
| 30724096 | Derived | Wang ST, Johnson SJ, Mitchell D, Soliman AM, Vora JB, Agarwal SK. Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USA. J Comp Eff Res. 2019 Apr;8(5):337-355. doi: 10.2217/cer-2018-0124. Epub 2019 Feb 6. |
| 29476499 | Derived | Winzenborg I, Nader A, Polepally AR, Liu M, Degner J, Klein CE, Mostafa NM, Noertersheuser P, Ng J. Population Pharmacokinetics of Elagolix in Healthy Women and Women with Endometriosis. Clin Pharmacokinet. 2018 Oct;57(10):1295-1306. doi: 10.1007/s40262-018-0629-6. |
| Adverse Event |
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| Lost to Follow-up |
|
| Other |
|
| Subject Noncompliant |
|
| Pregnancy |
|
| Surgery/Invasive Intervention |
|
| Exclusionary Medication Received |
|
|
| Completed PTFU Month 12 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG002 | Elagolix 200 mg BID | Elagolix 200 mg BID for the 6-month Treatment Period |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Elagolix 150 mg QD |
Elagolix 150 mg QD for the 6-month Treatment Period |
| OG002 | Elagolix 200 mg BID | Elagolix 200 mg BID for the 6-month Treatment Period |
|
|
|
| Primary | Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP) | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set; all randomized participants who took at least 1 dose of randomized, double-blind study drug. Population included mITT participants who either had data during the Month 3 35-day window or who prematurely discontinued prior to or at Month 3 and met the rules for last observation carried forward. | Posted | Number | percentage of participants | At Month 3 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 3 of the Treatment Period |
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| Secondary | Change From Baseline to Month 6 in DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 of Treatment Period |
|
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| Secondary | Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | pills | Baseline, Month 3 of Treatment Period |
|
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|
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| Secondary | Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | pills | Baseline, Month 6 of Treatment Period |
|
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|
|
| Secondary | Change From Baseline to Month 3 in Dyspareunia (DYSP) | The DYSP pain scale ranges from 0 (absent) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids) | Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | pills | Baseline, Month 3 of Treatment Period |
|
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| Secondary | Percentage of Responders at Month 1 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 1 of the Treatment Period |
|
|
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| Secondary | Percentage of Responders at Month 2 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 2 of the Treatment Period |
|
|
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| Secondary | Percentage of Responders at Month 4 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 4 of the Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Month 5 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward.. | Posted | Number | percentage of participants | At Month 5 of the Treatment Period |
|
|
|
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| Secondary | Percentage of Responders at Month 6 Based on Daily Assessment of DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 6 of the Treatment Period |
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|
|
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| Secondary | Percentage of Responders at Month 1 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 1 of Treatment Period |
|
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| Secondary | Percentage of Responders at Month 2 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 2 of Treatment Period |
|
|
|
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| Secondary | Percentage of Responders at Month 4 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 4 of Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Month 5 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 5 of Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Month 6 Based on Daily Assessment of NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 6 of Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Month 1 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 1 of the Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Month 2 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 2 of the Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Month 4 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 4 of the Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Month 5 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 5 of the Treatment Period |
|
|
|
|
| Secondary | Percentage of Responders at Month 6 for DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Number | percentage of participants | At Month 6 of the Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 1 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 1 of Treatment Period |
|
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|
| Secondary | Change From Baseline to Month 2 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 2 of Treatment Period |
|
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|
|
| Secondary | Change From Baseline to Month 3 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 3 of Treatment Period |
|
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|
| Secondary | Change From Baseline to Month 4 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 4 of Treatment Period |
|
|
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|
| Secondary | Change From Baseline to Month 5 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 5 of Treatment Period |
|
|
|
|
| Secondary | Percent Change From Baseline to Month 1 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 1 of Treatment Period |
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| Secondary | Percent Change From Baseline to Month 2 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 2 of Treatment Period |
|
|
|
|
| Secondary | Percent Change From Baseline to Month 3 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 3 of Treatment Period |
|
|
|
|
| Secondary | Percent Change From Baseline to Month 4 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 4 of Treatment Period |
|
|
|
|
| Secondary | Percent Change From Baseline to Month 5 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 5 of Treatment Period |
|
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| Secondary | Percent Change From Baseline to Month 6 in Mean Pain Score for DYS | The DYS pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 6 of Treatment Period |
|
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| Secondary | Change From Baseline to Month 1 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 2 of Treatment Period |
|
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| Secondary | Change From Baseline to Month 3 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 3 of Treatment Period |
|
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| Secondary | Change From Baseline to Month 4 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 4 of Treatment Period |
|
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|
|
| Secondary | Change From Baseline to Month 5 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 5 of Treatment Period |
|
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|
| Secondary | Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 1 of Treatment Period |
|
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|
| Secondary | Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 2 of Treatment Period |
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| Secondary | Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 3 of Treatment Period |
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| Secondary | Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 4 of Treatment Period |
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| Secondary | Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 5 of Treatment Period |
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| Secondary | Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP | The NMPP pain scale ranges from 0 (none) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | percentage change | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 4 of Treatment Period |
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| Secondary | Change From Baseline to Month 5 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 5 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in Mean Pain Score of DYSP | The DYSP pain scale ranged from 0 (absent) to 3 (severe). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. Participants who responded "not applicable" for the entire time point and at Baseline are excluded from the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | pills | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | pills | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | pills | Baseline, Month 4 of Treatment Period |
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| Secondary | Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics | Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | pills | Baseline, Month 5 of Treatment Period |
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| Secondary | Response to Patient Global Impression of Change (PGIC) at Month 1 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 1 of Treatment Period |
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| Secondary | Response to PGIC at Month 2 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 2 of Treatment Period |
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| Secondary | Response to PGIC at Month 3 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 3 of Treatment Period |
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| Secondary | Response to PGIC at Month 4 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 4 of Treatment Period |
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| Secondary | Response to PGIC at Month 5 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 5 of Treatment Period |
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| Secondary | Response to PGIC at Month 6 | The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Last observation carried forward. | Posted | Least Squares Mean | Standard Error | units on a scale | Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 4 of Treatment Period |
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| Secondary | Change From Baseline to Month 5 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 5 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in NRS Scores | The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever). | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30) | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in the Pain Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in the Pain Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30 | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 4 of Treatment Period |
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| Secondary | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 5 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 4 of Treatment Period |
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| Secondary | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 5 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 4 of Treatment Period |
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| Secondary | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 5 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 4 of Treatment Period |
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| Secondary | Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 5 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism [working while sick]) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 4 of Treatment Period |
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| Secondary | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 5 of Treatment Period |
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| Secondary | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 6 of Treatment Period |
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| Secondary | Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 1 of Treatment Period |
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| Secondary | Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 2 of Treatment Period |
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| Secondary | Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 3 of Treatment Period |
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| Secondary | Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 4 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 5 of Treatment Period |
|
|
|
|
| Secondary | Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household | The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration. | The mITT analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Observed cases. | Posted | Least Squares Mean | Standard Error | hours | Baseline, Month 6 of Treatment Period |
|
|
|
|
| Secondary | Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period | The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. | Posted | Count of Participants | Participants | No | Up to Month 6 of Treatment Period |
|
|
|
| Secondary | Number of Days of Hospitalization | The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. Includes participants who were hospitalized during the Treatment Period. | Posted | Mean | Standard Deviation | days | Up to Month 6 of Treatment Period |
|
|
|
| Secondary | Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type | The modified intent-to-treat analysis set included all randomized participants who took at least 1 dose of randomized, double-blind study drug. | Posted | Count of Participants | Participants | No | Up to Month 6 of Treatment Period |
|
|
|
| 12 |
| 374 |
| 180 |
| 374 |
| EG001 | Elagolix 150 MG QD | Elagolix 150 mg QD for the 6-month Treatment Period | 2 | 249 | 147 | 249 |
| EG002 | Elagolix 200 MG BID | Elagolix 200 mg BID for the 6-month Treatment Period | 7 | 248 | 159 | 248 |
| CHEST PAIN | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE COLITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| MENINGITIS VIRAL | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| BLOOD POTASSIUM DECREASED | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| SYNOVITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| ECTOPIC PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA 18.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| URETERIC STENOSIS | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
|
| ENDOMETRIOSIS | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| HAEMORRHAGIC OVARIAN CYST | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| OVARIAN CYST RUPTURED | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| PELVIC PAIN | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| VICTIM OF SEXUAL ABUSE | Social circumstances | MedDRA 18.0 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
|
| AMENORRHOEA | Reproductive system and breast disorders | MedDRA 18.0 | Systematic Assessment |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
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.
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Superiority |
| mixed-effects model |
| < 0.001 |
| Difference in LS Mean Change |
| -1.30 |
| Standard Error of the Mean |
| 0.156 |
| 2-Sided |
| Superiority |
| mixed-effects model |
| < 0.001 |
| Difference in Least Squares Mean |
| -1.32 |
| Standard Error of the Mean |
| 0.076 |
| 2-Sided |
| Superiority |
| mixed-effects model |
| < 0.001 |
| Least Squares Mean Difference |
| -0.41 |
| Standard Error of the Mean |
| 0.057 |
| 2-Sided |
| Superiority |
| mixed-effects model |
| < 0.001 |
| Difference in LS Mean Change |
| -0.26 |
| Standard Error of the Mean |
| 0.051 |
| 2-Sided |
| Superiority |
| mixed-effects model |
| < 0.001 |
| Least Squares Mean Difference |
| -0.28 |
| Standard Error of the Mean |
| 0.057 |
| 2-Sided |
| Superiority |
| mixed-effects model |
| 0.003 |
| Difference in LS Mean Change |
| -0.20 |
| Standard Error of the Mean |
| 0.067 |
| 2-Sided |
| Superiority |
| mixed-effects model |
| 0.002 |
| Difference in LS Mean Change |
| -0.12 |
| Standard Error of the Mean |
| 0.038 |
| 2-Sided |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -0.65 |
| Standard Error of the Mean |
| 0.070 |
| 2-Sided |
| 97.5 |
| -0.81 |
| -0.49 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -1.36 |
| Standard Error of the Mean |
| 0.068 |
| 2-Sided |
| 97.5 |
| -1.51 |
| -1.20 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -1.39 |
| Standard Error of the Mean |
| 0.069 |
| 2-Sided |
| 97.5 |
| -1.54 |
| -1.23 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -1.32 |
| Standard Error of the Mean |
| 0.072 |
| 2-Sided |
| 97.5 |
| -1.49 |
| -1.16 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -1.41 |
| Standard Error of the Mean |
| 0.072 |
| 2-Sided |
| 97.5 |
| -1.58 |
| -1.25 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -31.01 |
| Standard Error of the Mean |
| 3.299 |
| 2-Sided |
| 97.5 |
| -38.41 |
| -23.60 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -63.78 |
| Standard Error of the Mean |
| 3.148 |
| 2-Sided |
| 97.5 |
| -70.85 |
| -56.71 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -64.94 |
| Standard Error of the Mean |
| 3.230 |
| 2-Sided |
| 97.5 |
| -72.19 |
| -57.68 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -61.90 |
| Standard Error of the Mean |
| 3.356 |
| 2-Sided |
| 97.5 |
| -69.44 |
| -54.36 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -66.50 |
| Standard Error of the Mean |
| 3.321 |
| 2-Sided |
| 97.5 |
| -73.95 |
| -59.04 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -60.78 |
| Standard Error of the Mean |
| 3.557 |
| 2-Sided |
| 97.5 |
| -68.77 |
| -52.79 |
| Superiority |
| LS Mean of Difference |
| -0.10 |
| Standard Error of the Mean |
| 0.036 |
| 2-Sided |
| 97.5 |
| -0.18 |
| -0.01 |
| Superiority |
| LS Mean of Difference |
| -0.18 |
| Standard Error of the Mean |
| 0.045 |
| 2-Sided |
| 97.5 |
| -0.28 |
| -0.08 |
| Superiority |
| LS Mean of Difference |
| -0.29 |
| Standard Error of the Mean |
| 0.050 |
| 2-Sided |
| 97.5 |
| -0.41 |
| -0.18 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -0.39 |
| Standard Error of the Mean |
| 0.054 |
| 2-Sided |
| 97.5 |
| -0.51 |
| -0.27 |
| Superiority |
| LS Mean of Difference |
| -0.39 |
| Standard Error of the Mean |
| 0.054 |
| 2-Sided |
| 97.5 |
| -0.52 |
| -0.27 |
| Superiority |
| LS Mean of Difference |
| -7.72 |
| Standard Error of the Mean |
| 2.756 |
| 2-Sided |
| 97.5 |
| -13.90 |
| -1.53 |
| Superiority |
| LS Mean of Difference |
| -13.72 |
| Standard Error of the Mean |
| 3.249 |
| 2-Sided |
| 97.5 |
| -21.01 |
| -6.42 |
| Superiority |
| LS Mean of Difference |
| -22.49 |
| Standard Error of the Mean |
| 3.514 |
| 2-Sided |
| 97.5 |
| -30.38 |
| -14.60 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -30.41 |
| Standard Error of the Mean |
| 3.729 |
| 2-Sided |
| 97.5 |
| -38.78 |
| -22.04 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -29.68 |
| Standard Error of the Mean |
| 3.788 |
| 2-Sided |
| 97.5 |
| -38.19 |
| -21.18 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -29.97 |
| Standard Error of the Mean |
| 3.868 |
| 2-Sided |
| 97.5 |
| -38.66 |
| -21.28 |
| Superiority |
| LS Mean of Difference |
| -0.04 |
| Standard Error of the Mean |
| 0.053 |
| 2-Sided |
| 97.5 |
| -0.16 |
| 0.08 |
| Superiority |
| LS Mean of Difference |
| -0.12 |
| Standard Error of the Mean |
| 0.061 |
| 2-Sided |
| 97.5 |
| -0.25 |
| 0.02 |
| Superiority |
| LS Mean of Difference |
| -0.34 |
| Standard Error of the Mean |
| 0.071 |
| 2-Sided |
| 97.5 |
| -0.50 |
| -0.18 |
| Superiority |
| LS Mean of Difference |
| -0.27 |
| Standard Error of the Mean |
| 0.076 |
| 2-Sided |
| 97.5 |
| -0.44 |
| -0.10 |
| Superiority |
| LS Mean of Difference |
| -0.30 |
| Standard Error of the Mean |
| 0.078 |
| 2-Sided |
| 97.5 |
| -0.48 |
| -0.13 |
| Superiority |
| LS Mean of Difference |
| -0.12 |
| Standard Error of the Mean |
| 0.044 |
| 2-Sided |
| 97.5 |
| -0.22 |
| -0.02 |
| Superiority |
| LS Mean of Difference |
| -0.22 |
| Standard Error of the Mean |
| 0.047 |
| 2-Sided |
| 97.5 |
| -0.32 |
| -0.11 |
| Superiority |
| LS Mean of Difference |
| -0.29 |
| Standard Error of the Mean |
| 0.053 |
| 2-Sided |
| 97.5 |
| -0.41 |
| -0.17 |
| Superiority |
| LS Mean of Difference |
| -0.30 |
| Standard Error of the Mean |
| 0.054 |
| 2-Sided |
| 97.5 |
| -0.42 |
| -0.18 |
| Superiority |
| LS Mean of Difference |
| -0.74 |
| Standard Error of the Mean |
| 0.095 |
| 2-Sided |
| 95 |
| -0.93 |
| -0.56 |
| Superiority |
| LS Mean of Difference |
| -1.02 |
| Standard Error of the Mean |
| 0.099 |
| 2-Sided |
| 95 |
| -1.21 |
| -0.82 |
| Superiority |
| LS Mean of Difference |
| -1.12 |
| Standard Error of the Mean |
| 0.102 |
| 2-Sided |
| 95 |
| -1.32 |
| -0.92 |
| Superiority |
| LS Mean of Difference |
| -1.26 |
| Standard Error of the Mean |
| 0.107 |
| 2-Sided |
| 95 |
| -1.47 |
| -1.05 |
| Superiority |
| LS Mean of Difference |
| -1.32 |
| Standard Error of the Mean |
| 0.112 |
| 2-Sided |
| 95 |
| -1.54 |
| -1.10 |
| Superiority |
| LS Mean of Difference |
| -1.35 |
| Standard Error of the Mean |
| 0.123 |
| 2-Sided |
| 95 |
| -1.59 |
| -1.11 |
| Superiority |
| LS Mean of Difference |
| -0.40 |
| Standard Error of the Mean |
| 0.110 |
| 2-Sided |
| 97.5 |
| -0.65 |
| -0.16 |
| Superiority |
| LS Mean of Difference |
| -0.96 |
| Standard Error of the Mean |
| 0.138 |
| 2-Sided |
| 97.5 |
| -1.27 |
| -0.65 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -1.61 |
| Standard Error of the Mean |
| 0.165 |
| 2-Sided |
| 97.5 |
| -1.98 |
| -1.24 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -1.61 |
| Standard Error of the Mean |
| 0.170 |
| 2-Sided |
| 97.5 |
| -1.99 |
| -1.23 |
| Superiority |
| < 0.001 |
| LS Mean of Difference |
| -1.60 |
| Standard Error of the Mean |
| 0.179 |
| 2-Sided |
| 97.5 |
| -2.00 |
| -1.20 |
| Superiority |
| Difference in LS Means |
| -9.76 |
| Standard Error of the Mean |
| 1.60 |
| 2-Sided |
| 95 |
| -12.91 |
| -6.61 |
| Superiority |
| Difference in LS Means |
| -18.75 |
| Standard Error of the Mean |
| 1.77 |
| 2-Sided |
| 95 |
| -22.22 |
| -15.27 |
| Superiority |
| Difference in LS Means |
| -25.10 |
| Standard Error of the Mean |
| 2.04 |
| 2-Sided |
| 95 |
| -29.12 |
| -21.09 |
| Superiority |
| Difference in LS Means |
| -5.04 |
| Standard Error of the Mean |
| 2.03 |
| 2-Sided |
| 95 |
| -9.04 |
| -1.05 |
| Superiority |
| Difference in LS Means |
| -13.86 |
| Standard Error of the Mean |
| 2.56 |
| 2-Sided |
| 95 |
| -18.89 |
| -8.84 |
| Superiority |
| Difference in LS Means |
| -17.51 |
| Standard Error of the Mean |
| 3.06 |
| 2-Sided |
| 95 |
| -23.52 |
| -11.50 |
| Superiority |
| Difference in LS Means |
| -1.16 |
| Standard Error of the Mean |
| 0.38 |
| 2-Sided |
| 95 |
| -1.90 |
| -0.42 |
| Superiority |
| Difference in LS Means |
| -1.27 |
| Standard Error of the Mean |
| 0.36 |
| 2-Sided |
| 95 |
| -1.97 |
| -0.57 |
| Superiority |
| Difference in LS Means |
| -1.78 |
| Standard Error of the Mean |
| 0.44 |
| 2-Sided |
| 95 |
| -2.65 |
| -0.91 |
| Superiority |
| Difference in LS Means |
| -1.37 |
| Standard Error of the Mean |
| 0.45 |
| 2-Sided |
| 95 |
| -2.25 |
| -0.48 |
| Superiority |
| Difference in LS Means |
| -1.85 |
| Standard Error of the Mean |
| 0.42 |
| 2-Sided |
| 95 |
| -2.67 |
| -1.02 |
| Superiority |
| Difference in LS Means |
| -2.21 |
| Standard Error of the Mean |
| 0.65 |
| 2-Sided |
| 95 |
| -3.48 |
| -0.93 |
| Superiority |
| Difference in LS Means |
| -1.62 |
| Standard Error of the Mean |
| 0.37 |
| 2-Sided |
| 95 |
| -2.35 |
| -0.90 |
| Superiority |
| Difference in LS Means |
| -1.64 |
| Standard Error of the Mean |
| 0.47 |
| 2-Sided |
| 95 |
| -2.56 |
| -0.71 |
| Superiority |
| Difference in LS Means |
| -2.10 |
| Standard Error of the Mean |
| 0.47 |
| 2-Sided |
| 95 |
| -3.02 |
| -1.19 |
| Superiority |
| Difference in LS Means |
| -2.23 |
| Standard Error of the Mean |
| 0.42 |
| 2-Sided |
| 95 |
| -3.06 |
| -1.40 |
| Superiority |
| Difference in LS Means |
| -1.81 |
| Standard Error of the Mean |
| 0.39 |
| 2-Sided |
| 95 |
| -2.58 |
| -1.04 |
| Superiority |
| Difference in LS Means |
| -2.49 |
| Standard Error of the Mean |
| 0.48 |
| 2-Sided |
| 95 |
| -3.44 |
| -1.54 |
| Superiority |
| Difference in LS Means |
| -1.93 |
| Standard Error of the Mean |
| 0.89 |
| 2-Sided |
| 95 |
| -3.67 |
| -0.18 |
| Superiority |
| Difference in LS Means |
| -3.52 |
| Standard Error of the Mean |
| 0.90 |
| 2-Sided |
| 95 |
| -5.28 |
| -1.75 |
| Superiority |
| Difference in LS Means |
| -2.93 |
| Standard Error of the Mean |
| 0.84 |
| 2-Sided |
| 95 |
| -4.59 |
| -1.28 |
| Superiority |
| Difference in LS Means |
| -3.89 |
| Standard Error of the Mean |
| 0.74 |
| 2-Sided |
| 95 |
| -5.34 |
| -2.43 |
| Superiority |
| Difference in LS Means |
| -3.13 |
| Standard Error of the Mean |
| 0.80 |
| 2-Sided |
| 95 |
| -4.70 |
| -1.56 |
| Superiority |
| Difference in LS Means |
| -4.47 |
| Standard Error of the Mean |
| 0.88 |
| 2-Sided |
| 95 |
| -6.19 |
| -2.74 |
| Superiority |
| Difference in LS Means |
| -1.05 |
| Standard Error of the Mean |
| 0.36 |
| 2-Sided |
| 95 |
| -1.76 |
| -0.34 |
| Superiority |
| Difference in LS Means |
| -1.06 |
| Standard Error of the Mean |
| 0.38 |
| 2-Sided |
| 95 |
| -1.81 |
| -0.31 |
| Superiority |
| Difference in LS Means |
| -0.98 |
| Standard Error of the Mean |
| 0.34 |
| 2-Sided |
| 95 |
| -1.64 |
| -0.32 |
| Superiority |
| Difference in LS Means |
| -1.05 |
| Standard Error of the Mean |
| 0.36 |
| 2-Sided |
| 95 |
| -1.75 |
| -0.35 |
| Superiority |
| Difference in LS Means |
| -1.04 |
| Standard Error of the Mean |
| 0.27 |
| 2-Sided |
| 95 |
| -1.57 |
| -0.52 |
| Superiority |
| Difference in LS Means |
| -1.30 |
| Standard Error of the Mean |
| 0.36 |
| 2-Sided |
| 95 |
| -2.01 |
| -0.59 |
| Superiority |
| Difference in LS Means |
| -3.23 |
| Standard Error of the Mean |
| 0.98 |
| 2-Sided |
| 95 |
| -5.16 |
| -1.30 |
| Superiority |
| Difference in LS Means |
| -4.86 |
| Standard Error of the Mean |
| 1.00 |
| 2-Sided |
| 95 |
| -6.82 |
| -2.90 |
| Superiority |
| Difference in LS Means |
| -4.91 |
| Standard Error of the Mean |
| 1.04 |
| 2-Sided |
| 95 |
| -6.95 |
| -2.86 |
| Superiority |
| Difference in LS Means |
| -5.25 |
| Standard Error of the Mean |
| 0.96 |
| 2-Sided |
| 95 |
| -7.14 |
| -3.36 |
| Superiority |
| Difference in LS Means |
| -5.13 |
| Standard Error of the Mean |
| 0.98 |
| 2-Sided |
| 95 |
| -7.06 |
| -3.20 |
| Superiority |
| Difference in LS Means |
| -6.79 |
| Standard Error of the Mean |
| 1.21 |
| 2-Sided |
| 95 |
| -9.17 |
| -4.41 |
| Superiority |
| Difference in LS Means |
| -2.60 |
| Standard Error of the Mean |
| 0.57 |
| 2-Sided |
| 95 |
| -3.71 |
| -1.49 |
| Superiority |
| Difference in LS Means |
| -2.65 |
| Standard Error of the Mean |
| 0.68 |
| 2-Sided |
| 95 |
| -3.98 |
| -1.32 |
| Superiority |
| Difference in LS Means |
| -3.00 |
| Standard Error of the Mean |
| 0.63 |
| 2-Sided |
| 95 |
| -4.23 |
| -1.76 |
| Superiority |
| Difference in LS Means |
| -3.24 |
| Standard Error of the Mean |
| 0.64 |
| 2-Sided |
| 95 |
| -4.50 |
| -1.98 |
| Superiority |
| Difference in LS Means |
| -2.83 |
| Standard Error of the Mean |
| 0.55 |
| 2-Sided |
| 95 |
| -3.91 |
| -1.74 |
| Superiority |
| Difference in LS Means |
| -3.75 |
| Standard Error of the Mean |
| 0.67 |
| 2-Sided |
| 95 |
| -5.06 |
| -2.44 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Month 2 |
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| Overall |
|
| Title | Measurements |
|---|---|
|
| Angiography |
|
| Arthroscopy |
|
| Biopsy |
|
| Blood Draw |
|
| Consultation |
|
| CT Scan |
|
| Diagnostic Laparoscopy |
|
| Electrocardiogram |
|
| Endometrial Ablation |
|
| Histological Exam |
|
| Intrauterine Insemination |
|
| In Vitro Fertilization |
|
| Laparoscopic Hysterectomy |
|
| Laparotomy |
|
| Magnetic Resonance Imaging |
|
| Oophorectomy |
|
| Pelvic Exam |
|
| Physical Examination |
|
| Surgery for Adhesions |
|
| Therapeutic Laparoscopy |
|
| Transfusion |
|
| Ultrasound |
|
| Urine Test |
|
| Vaginal Hysterectomy |
|
| X-Ray |
|
| Other (Not Specified) |
|