| Primary | Proportion of Responders at Month 6 Based on DYS Pain Scale | Proportion of responders at Month 6 based upon the scale for DYS pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain. | Analysis was intended to be based on a receiver operating characteristic (ROC) threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination. | Posted | | | | | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
| | | |
| Primary | Proportion of Responders at Month 6 Based on NMPP Pain Scale | Proportion of responders at Month 6 based upon the scale for NMPP pain scale (ranging from 0 [none] to 3 [severe]) using the daily e-Diary, as well as no increased analgesic rescue use for endometriosis-associated pain. | Analysis was intended to be based on ROC threshold, which could not be calculated, since only 1 participant had a Month 6 assessment for this endpoint at the time of study termination. | Posted | | | | | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Change From Baseline in DYS at Month 6 | The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | Change From Baseline in NMPP at Month 6 | The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | Change From Baseline in Dyspareunia at Month 6 | The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6 | The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 | Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | pills/day | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C |
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| Secondary | Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6 | The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. | Participants with both baseline and post-baseline values for Daily Diary Endometriosis-Associated Pain Score via NRS. | Posted | | Number | | percentage of participants | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C |
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| Secondary | Proportion of Responders Over Time | As assessed by change and percent change from baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively. | Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination. | Posted | | | | | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use) | As assessed by change and percent change from Baseline in average pain score and rescue analgesic use monthly for DYS, NMPP, dyspareunia, and Daily Diary endometriosis-associated pain score via NRS, respectively. | Analysis was intended to be based on ROC threshold, which could not be calculated for this endpoint due to low enrollment at the time of study termination. | Posted | | | | | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Change From Baseline Over Time in Monthly Average DYS Pain Score | The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. The analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | |
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| Secondary | Change From Baseline Over Time in Monthly Average NMPP Pain Score | The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Percent Change From Baseline to Each Month During the Treatment Period for DYS | The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | percent change of units on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | percentage change of units on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | percentage change of units on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | percentage change of score on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C |
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| Secondary | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Based on average pill counts and assessed using a daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen. | Participants with an assessment at baseline and given time point. | Posted | | Mean | Standard Deviation | pills/day | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C |
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| Secondary | Number of Analgesic Use Responders and Non-Responders Over Time | Based only on reduction of rescue analgesics used. Responders were defined as:
- participants with no analgesic use at screening and no analgesic use added
- participants with NSAID only use at screening and NSAID dose stopped, decreased, or stable (<15% increase) and no opioid use added
- participants with opioid only use at screening and opioid dose stopped, decreased, or stable (<15% increase), opioid dose stopped and NSAID substituted (any dose), opioid dose decreased and NSAID added (any dose)
- participants with NSAID + opioid use at screening and any of the following: NSAID dose stopped + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose decreased + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose stable (< 15% increase) + opioid analgesic use stopped, decreased, or stable (<15% increase); NSAID dose increased by >15% + opioid analgesic use stopped; NSAID dose increased by >15% + opioid analgesic dose decreases.
| | Posted | | Count of Participants | | Participants | | Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | Patient Global Impression of Change (PGIC) Scores Over Time | The PGIC is a 7-point response scale where participants rate their endometriosis related pain as: very much improved (1), much improved (2), minimally improved (3), not changed (4), minimally worse (5), much worse (6), very much worse (7). | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | The endometriosis-associated pain questionnaire is an 11-point NRS assessing overall endometriosis-associated pain over a 7-day recall period. Participants assessed their endometriosis-associated pain on a scale of 0 to 10, with 0 = no pain and 10 = worst pain ever. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | |
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| Secondary | Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 |
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| Secondary | EHP-30 Scores Over Time: Control and Powerlessness | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 |
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| Secondary | EHP-30 Scores Over Time: Emotional Well-Being | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 |
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| Secondary | EHP-30 Scores Over Time: Social Support | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 |
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| Secondary | EHP-30 Scores Over Time: Self-Image | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 |
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| Secondary | EHP-30 Scores Over Time: Sexual Intercourse | The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Domains used in the study included Pain, Control and Powerlessness, Well-Being, Social Support, Self-Image, and Sexual Intercourse. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 |
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| Secondary | EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable). | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | EQ-5D-5L Scores Over Time: Self-Care | The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable). | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | EQ-5D-5L Scores Over Time: Usual Activities | The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable). | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | EQ-5D-5L Scores Over Time: Pain/Discomfort | The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable). | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | EQ-5D-5L Scores Over Time: Anxiety/Depression | The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate visual analog scale (VAS) indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable). | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | EQ-5D-5L VAS Scores Over Time: Health Today | The EQ-5D-5L is a health state utility instrument with 5 items that comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which is rated on 5 levels of severity (1=no problem, 2=slight problems, 3=moderate problems, 4=severe problems, 5=extreme problems) and a separate VAS indicating a participant's rating of their current health status (health today) on a scale of from 0 (worst health imaginable) to 100 (best health imaginable). | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem | Absenteeism is presented as the mean percentage of work time missed due to health problem (as reported on the WPAI:SHP), and is calculated as: 100*number of hours of work missed due to health problem / (number of hours of work missed due to health problem + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | percent of work time missed | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
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| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem | Presenteeism (the extent to which health problem decreased productivity) is presented as the mean percentage of impairment while working due to health problem, and is calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI:SHP is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | percent impairment while working | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
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| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem | The mean percentage of overall work impairment due to health problem (based on the WPAI questionnaire) is presented, and is calculated as: Absenteeism (%) + extent to which health problem decreased productivity (%)* [number of hours worked / (number of hours of work missed due to health problem + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | percent overall work impairment | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
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| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem | Activity impairment due to health problem (the extent to which health problem affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, and is calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | percentage impairment of activity | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
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| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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| Secondary | Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | The 6-item ETSQ was developed to assess patient-reported satisfaction with effects on endometriosis pain, dysmenorrhea, dyspareunia, amount of bleeding tolerability and overall treatment satisfaction. The ETSQ has a 7 point response scale. The range for this scale is 0 to 36, with lower ETSQ scores reflecting lower levels of satisfaction with endometriosis treatment. | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Months 3, 6 | | | | ID | Title | Description |
|---|
| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 |
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| Secondary | PROMIS Fatigue Short Form 6a Scores Over Time | The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue. Possible scores range from 6 to 30, 6 = not at all (no fatigue), and 30 = very much (most fatigue). | Participants with an assessment at given time point. | Posted | | Mean | Standard Deviation | score on a scale | | Month 0 (baseline), Month 6 | | | | ID | Title | Description |
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| OG000 | Group A | Day 1 through Month 3 (open-label): elagolix 150 mg QD Participants discontinued prematurely during the open-label period. | | OG001 | Group B | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Efficacy responders to elagolix 150 mg QD Month 3 continued on elagolix 150 mg QD The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via a Numeric Rating Scale (NRS) in the electronic diary. Efficacy responder: ≥ 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. | | OG002 | Group C | Day 1 Through Month 3 (Open-Label): Open-Label elagolix 150 mg QD Month 4 Through Month 6 (Double-Blind): Incomplete efficacy responders to elagolix 150 mg QD at Month 3 and randomized to elagolix 200 mg BID plus E2/NETA 1/0.5 mg QD treatment group The efficacy responder status of each participant was determined based on the responses to the Daily Diary endometriosis-associated pain score via NRS in the electronic diary. Incomplete efficacy responder: < 30% decrease (improvement) from Baseline based on the average of the Daily Diary for endometriosis-associated pain score via NRS over a 35 day window. |
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