Endometriosis
Conditions
Keywords
Endometriosis associated pain, Elagolix, Non-menstrual pelvic pain (NMPP), Dysmenorrhea (DYS)
Brief summary
This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.
Interventions
DRUGelagolix
Tablets
Capsules
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening. * Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization or histology within 10 years prior to entry into Washout or Screening, * Participant must agree to use only those rescue analgesics permitted by the protocol during the Screening and Treatment Periods for her endometriosis-associated pain. * Participant must have the following documented in the e-Diary during the last 35 days prior to Study Day 1: 1. At least 2 days of moderate or severe DYS, AND either, 2. At least 2 days of moderate or severe NMPP and an average NMPP score of at least 1.0, OR 3. At least 4 days of moderate or severe NMPP and an average NMPP score of at least 0.5.
Exclusion criteria
* Participant has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-associated pain. * Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed. * Participant has a history of major depression or post-traumatic stress disorder (PTSD) within 2 years prior to screening or other major psychiatric disorder at any time * Participant has a history of suicide attempts or answered yes to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening or prior to study drug dosing on Day 1. * Participant has any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (DXA) measurements * Screening DXA results of the lumbar spine (L1 - L4), femoral neck or total hip bone mineral density (BMD) corresponding to less than 2 or more standard deviations below normal (Z-score \< -2.0 for participants \< 40 years of age, T-score for participants \>= 40 years of age). * Participant has either 1. a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension) that has not been stabilized 30 days prior to enrollment on Day 1 OR 2. a clinically significant medical condition that is anticipated to required intervention during the course of study participation (e.g., anticipated major elective surgery) OR 3. an unstable medical condition that makes the participant an unsuitable candidate for the study in the opinion of the Investigator * Participant has any conditions contraindicated with use of E2/NETA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Responders at Month 6 Based on DYS Pain Scale | Month 6 | 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. |
| Proportion of Responders at Month 6 Based on NMPP Pain Scale | Month 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Dyspareunia at Month 6 | Month 0 (baseline), 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. |
| Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6 | Month 0 (baseline), 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. |
| Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 | Month 0 (baseline), 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. |
| 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 | 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. |
| Proportion of Responders Over Time | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | 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. |
| Proportion of Responders Over Time (Not Taking Into Consideration of Analgesic Use) | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | 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. |
| Change From Baseline Over Time in Monthly Average DYS Pain Score | Month 0 (baseline), Months 1, 2, 3, 4, 5, 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. 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. |
| Change From Baseline Over Time in Monthly Average NMPP Pain Score | Month 0 (baseline), Months 1, 2, 3, 4, 5, 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. |
| Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Month 0 (baseline), Months 1, 2, 3, 4, 5, 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. |
| Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Month 0 (baseline), Months 1, 2, 3, 4, 5, 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. |
| Percent Change From Baseline to Each Month During the Treatment Period for DYS | Month 0 (baseline), Months 1, 2, 3, 4, 5, 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. |
| Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Month 0 (baseline), Months 1, 2, 3, 4, 5, 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. |
| Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Month 0 (baseline), Months 1, 2, 3, 4, 5, 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. |
| Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Month 0 (baseline), Months 1, 2, 3, 4, 5, 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. |
| Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | 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. |
| Number of Analgesic Use Responders and Non-Responders Over Time | Months 1, 2, 3, 4, 5, 6 | 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. |
| Patient Global Impression of Change (PGIC) Scores Over Time | Months 1, 2, 3, 4, 5, 6 | 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). |
| Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 0 (baseline), Months 1, 2, 3, 4, 5, 6 | 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. |
| Change From Baseline in DYS at Month 6 | Month 0 (baseline), 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. |
| EHP-30 Scores Over Time: Control and Powerlessness | Month 0 (baseline), Months 3, 6 | 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. |
| EHP-30 Scores Over Time: Emotional Well-Being | Month 0 (baseline), Months 3, 6 | 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. |
| EHP-30 Scores Over Time: Self-Image | Month 0 (baseline), Months 3, 6 | 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. |
| EHP-30 Scores Over Time: Social Support | Month 0 (baseline), Months 3, 6 | 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. |
| EHP-30 Scores Over Time: Sexual Intercourse | Month 0 (baseline), Months 3, 6 | 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. |
| EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | Month 0 (baseline), Months 3, 6 | 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). |
| EQ-5D-5L Scores Over Time: Self-Care | Month 0 (baseline), Months 3, 6 | 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). |
| EQ-5D-5L Scores Over Time: Usual Activities | Month 0 (baseline), Months 3, 6 | 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). |
| EQ-5D-5L Scores Over Time: Pain/Discomfort | Month 0 (baseline), Months 3, 6 | 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). |
| EQ-5D-5L Scores Over Time: Anxiety/Depression | Month 0 (baseline), Months 3, 6 | 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). |
| EQ-5D-5L VAS Scores Over Time: Health Today | Month 0 (baseline), Months 3, 6 | 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). |
| Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | Month 0 (baseline), Months 3, 6 | 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. |
| Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem | Month 0 (baseline), Month 6 | 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. |
| WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem | Month 0 (baseline), Month 6 | 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. |
| PROMIS Fatigue Short Form 6a Scores Over Time | Month 0 (baseline), Month 6 | 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). |
| WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem | Month 0 (baseline), Month 6 | 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. |
| WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem | Month 0 (baseline), Month 6 | 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. |
| Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | Month 0 (baseline), Months 3, 6 | 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. |
| Change From Baseline in NMPP at Month 6 | Month 0 (baseline), 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. |
Countries
United States
Participant flow
Pre-assignment details
The study was terminated early for business reasons, not for safety concerns. There are no subject data past Treatment Month 6.
Participants by arm
| Arm | Count |
|---|---|
| Group A Day 1 through Month 3 (open-label): elagolix 150 mg QD
Participants discontinued prematurely during the open-label period. | 7 |
| 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. | 3 |
| 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. | 1 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Double Blind Period: Month 3 to Month 6 | Study Terminated by Sponsor | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | Group A | Group B | Group C | Total |
|---|---|---|---|---|
| Age, Customized 20 to < 25 years | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age, Customized 25 to < 30 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Customized 30 to < 35 years | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Customized 35 to < 40 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Customized 40 to < 45 years | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Age, Customized 45 to < 50 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) | 5.176 score on a scale STANDARD_DEVIATION 1.9302 | 3.638 score on a scale STANDARD_DEVIATION 1.5692 | 7.371 score on a scale | 4.956 score on a scale STANDARD_DEVIATION 1.9663 |
| Dysmenorrhea (DYS) Pain Scale | 0.641 score on a scale STANDARD_DEVIATION 0.1689 | 0.429 score on a scale STANDARD_DEVIATION 0.103 | 0.600 score on a scale | 0.579 score on a scale STANDARD_DEVIATION 0.1696 |
| Dyspareunia Pain Scale | 0.539 score on a scale STANDARD_DEVIATION 0.9064 | 0.043 score on a scale STANDARD_DEVIATION 0.0202 | 3.000 score on a scale | 0.686 score on a scale STANDARD_DEVIATION 1.1187 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 2 Participants | 0 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Non-Menstrual Pelvic Pain (NMPP) Pain Scale | 1.053 score on a scale STANDARD_DEVIATION 0.4534 | 0.914 score on a scale STANDARD_DEVIATION 0.4721 | 2.400 score on a scale | 1.138 score on a scale STANDARD_DEVIATION 0.5893 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 1 Participants | 0 Participants | 6 Participants |
| Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) NSAID | 2.388 pills/day STANDARD_DEVIATION 2.7765 | 0.581 pills/day STANDARD_DEVIATION 0.933 | 0.743 pills/day | 1.745 pills/day STANDARD_DEVIATION 2.3655 |
| Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) NSAID + Opioid | 2.629 pills/day STANDARD_DEVIATION 2.6903 | 0.638 pills/day STANDARD_DEVIATION 0.8918 | 1.314 pills/day | 1.966 pills/day STANDARD_DEVIATION 2.3196 |
| Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) Opioid | 0.241 pills/day STANDARD_DEVIATION 0.375 | 0.057 pills/day STANDARD_DEVIATION 0.099 | 0.571 pills/day | 0.221 pills/day STANDARD_DEVIATION 0.327 |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 1 Participants | 11 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 3 / 7 | 3 / 3 | 1 / 1 |
| serious Total, serious adverse events | 0 / 7 | 0 / 3 | 0 / 1 |
Outcome results
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.
Time frame: Month 6
Population: 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.
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.
Time frame: Month 6
Population: 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.
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group B | Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6 | -1.36 score on a scale | Standard Deviation 0.02 |
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group B | Change From Baseline in DYS at Month 6 | -0.23 score on a scale |
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group B | Change From Baseline in Dyspareunia at Month 6 | 0.29 score on a scale |
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group B | Change From Baseline in NMPP at Month 6 | -0.13 score on a scale | Standard Deviation 0.061 |
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group B | Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 | Opioid: Change at Month 6 | 0.09 pills/day | Standard Deviation 0.121 |
| Group B | Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 | NSAID: Change at Month 6 | 0.63 pills/day | Standard Deviation 0.606 |
| Group B | Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 | NSAID + Opioid: Change at Month 6 | 0.71 pills/day | Standard Deviation 0.485 |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 4 | -0.34 pills/day | — |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 3 | -0.96 pills/day | Standard Deviation 1.03 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 3 | -1.13 pills/day | Standard Deviation 1.273 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 3 | -0.17 pills/day | Standard Deviation 0.242 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 4 | -1.69 pills/day | — |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 1 | -0.84 pills/day | Standard Deviation 0.796 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 2 | -0.17 pills/day | Standard Deviation 0.263 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 2 | -1.33 pills/day | Standard Deviation 0.767 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 1 | -0.72 pills/day | Standard Deviation 1.178 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 1 | 0.12 pills/day | Standard Deviation 0.552 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 2 | -1.15 pills/day | Standard Deviation 0.785 |
| Group A | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 4 | -2.03 pills/day | — |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 1 | 0.03 pills/day | Standard Deviation 0.436 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 4 | -0.00 pills/day | Standard Deviation 0.863 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 5 | 0.18 pills/day | Standard Deviation 1.217 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 6 | 0.71 pills/day | Standard Deviation 0.485 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 1 | 0.09 pills/day | Standard Deviation 0.388 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 2 | -0.17 pills/day | Standard Deviation 0.834 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 3 | -0.43 pills/day | Standard Deviation 1.091 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 4 | 0.01 pills/day | Standard Deviation 0.845 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 5 | 0.23 pills/day | Standard Deviation 1.197 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 6 | 0.63 pills/day | Standard Deviation 0.606 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 1 | -0.06 pills/day | Standard Deviation 0.099 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 2 | -0.03 pills/day | Standard Deviation 0.049 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 3 | 0.02 pills/day | Standard Deviation 0.016 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 4 | -0.01 pills/day | Standard Deviation 0.044 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 5 | -0.05 pills/day | Standard Deviation 0.082 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 6 | 0.09 pills/day | Standard Deviation 0.121 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 3 | -0.41 pills/day | Standard Deviation 1.107 |
| Group B | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 2 | -0.20 pills/day | Standard Deviation 0.83 |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 2 | 0.63 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 1 | -1.10 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 4 | -0.40 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 4 | -1.03 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 3 | -1.20 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 1 | -0.43 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 4 | -0.63 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 1 | -0.67 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 2 | -0.51 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID: Change at Month 3 | -0.71 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | NSAID + Opioid: Change at Month 2 | -1.14 pills/day | — |
| Group C | Change From Baseline Over Time in Daily Rescue Analgesic Use Across Both Classes of Rescue Analgesics | Opioid: Change at Month 3 | -0.49 pills/day | — |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 1 | -0.86 score on a scale | Standard Deviation 1.975 |
| Group A | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 4 | -6.43 score on a scale | — |
| Group A | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 3 | -3.70 score on a scale | Standard Deviation 3.616 |
| Group A | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 2 | -2.40 score on a scale | Standard Deviation 2.106 |
| Group B | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 6 | -1.36 score on a scale | Standard Deviation 0.02 |
| Group B | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 1 | -0.89 score on a scale | Standard Deviation 1.159 |
| Group B | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 2 | -2.02 score on a scale | Standard Deviation 0.758 |
| Group B | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 3 | -1.81 score on a scale | Standard Deviation 0.43 |
| Group B | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 4 | -1.43 score on a scale | Standard Deviation 1.078 |
| Group B | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 5 | -1.40 score on a scale | Standard Deviation 0.961 |
| Group C | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 1 | -0.84 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 4 | -1.06 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 3 | -1.34 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS | Change at Month 2 | -1.40 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 4 | -0.69 score on a scale | — |
| Group A | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 3 | -0.50 score on a scale | Standard Deviation 0.263 |
| Group A | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 2 | -0.18 score on a scale | Standard Deviation 0.124 |
| Group A | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 1 | 0.05 score on a scale | Standard Deviation 0.655 |
| Group B | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 4 | -0.06 score on a scale | — |
| Group B | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 5 | -0.16 score on a scale | Standard Deviation 0.141 |
| Group B | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 6 | -0.23 score on a scale | — |
| Group B | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 1 | -0.04 score on a scale | — |
| Group B | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 2 | -0.26 score on a scale | — |
| Group B | Change From Baseline Over Time in Monthly Average DYS Pain Score | Change at Month 3 | -0.34 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 1 | -0.50 score on a scale | Standard Deviation 0.741 |
| Group A | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 4 | -2.23 score on a scale | — |
| Group A | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 3 | -2.20 score on a scale | — |
| Group A | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 2 | -1.44 score on a scale | Standard Deviation 1.071 |
| Group B | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 6 | 0.29 score on a scale | — |
| Group B | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 1 | 0.30 score on a scale | — |
| Group B | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 2 | 0.06 score on a scale | — |
| Group B | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 3 | 0.07 score on a scale | Standard Deviation 0.101 |
| Group B | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 4 | 0.09 score on a scale | Standard Deviation 0.04 |
| Group B | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 5 | 0.09 score on a scale | Standard Deviation 0.081 |
| Group C | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 1 | -0.29 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 4 | -0.03 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 3 | -0.03 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score | Change at Month 2 | -0.37 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 1 | -0.13 score on a scale | Standard Deviation 0.252 |
| Group A | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 4 | -1.34 score on a scale | — |
| Group A | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 3 | -0.70 score on a scale | Standard Deviation 0.828 |
| Group A | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 2 | -0.48 score on a scale | Standard Deviation 0.394 |
| Group B | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 6 | -0.13 score on a scale | Standard Deviation 0.061 |
| Group B | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 1 | -0.07 score on a scale | Standard Deviation 0.508 |
| Group B | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 2 | -0.30 score on a scale | Standard Deviation 0.167 |
| Group B | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 3 | -0.30 score on a scale | Standard Deviation 0.092 |
| Group B | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 4 | -0.34 score on a scale | Standard Deviation 0.029 |
| Group B | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 5 | -0.27 score on a scale | Standard Deviation 0.256 |
| Group C | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 1 | 0.39 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 4 | 0.46 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 3 | 0.54 score on a scale | — |
| Group C | Change From Baseline Over Time in Monthly Average NMPP Pain Score | Change at Month 2 | 0.29 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EHP-30 Scores Over Time: Control and Powerlessness | Month 3 | 36.46 score on a scale | Standard Deviation 32.874 |
| Group A | EHP-30 Scores Over Time: Control and Powerlessness | Baseline | 71.43 score on a scale | Standard Deviation 19.159 |
| Group B | EHP-30 Scores Over Time: Control and Powerlessness | Month 6 | 8.33 score on a scale | — |
| Group B | EHP-30 Scores Over Time: Control and Powerlessness | Month 3 | 26.39 score on a scale | Standard Deviation 21.382 |
| Group B | EHP-30 Scores Over Time: Control and Powerlessness | Baseline | 56.94 score on a scale | Standard Deviation 19.691 |
| Group C | EHP-30 Scores Over Time: Control and Powerlessness | Baseline | 41.67 score on a scale | — |
| Group C | EHP-30 Scores Over Time: Control and Powerlessness | Month 3 | 25.00 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EHP-30 Scores Over Time: Emotional Well-Being | Month 3 | 18.75 score on a scale | Standard Deviation 12.5 |
| Group A | EHP-30 Scores Over Time: Emotional Well-Being | Baseline | 29.76 score on a scale | Standard Deviation 8.815 |
| Group B | EHP-30 Scores Over Time: Emotional Well-Being | Month 6 | 25.00 score on a scale | — |
| Group B | EHP-30 Scores Over Time: Emotional Well-Being | Month 3 | 23.61 score on a scale | Standard Deviation 17.347 |
| Group B | EHP-30 Scores Over Time: Emotional Well-Being | Baseline | 50.00 score on a scale | Standard Deviation 8.333 |
| Group C | EHP-30 Scores Over Time: Emotional Well-Being | Baseline | 45.83 score on a scale | — |
| Group C | EHP-30 Scores Over Time: Emotional Well-Being | Month 3 | 37.50 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EHP-30 Scores Over Time: Self-Image | Month 3 | 43.75 score on a scale | Standard Deviation 41.597 |
| Group A | EHP-30 Scores Over Time: Self-Image | Baseline | 50.00 score on a scale | Standard Deviation 22.048 |
| Group B | EHP-30 Scores Over Time: Self-Image | Month 6 | 16.67 score on a scale | — |
| Group B | EHP-30 Scores Over Time: Self-Image | Month 3 | 8.33 score on a scale | Standard Deviation 14.434 |
| Group B | EHP-30 Scores Over Time: Self-Image | Baseline | 36.11 score on a scale | Standard Deviation 31.549 |
| Group C | EHP-30 Scores Over Time: Self-Image | Baseline | 75.00 score on a scale | — |
| Group C | EHP-30 Scores Over Time: Self-Image | Month 3 | 8.33 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EHP-30 Scores Over Time: Sexual Intercourse | Month 3 | 45.00 score on a scale | Standard Deviation 23.452 |
| Group A | EHP-30 Scores Over Time: Sexual Intercourse | Baseline | 70.00 score on a scale | Standard Deviation 22.361 |
| Group B | EHP-30 Scores Over Time: Sexual Intercourse | Month 6 | 30.00 score on a scale | — |
| Group B | EHP-30 Scores Over Time: Sexual Intercourse | Month 3 | 45.00 score on a scale | Standard Deviation 42.426 |
| Group B | EHP-30 Scores Over Time: Sexual Intercourse | Baseline | 62.50 score on a scale | Standard Deviation 31.82 |
| Group C | EHP-30 Scores Over Time: Sexual Intercourse | Baseline | 60.00 score on a scale | — |
| Group C | EHP-30 Scores Over Time: Sexual Intercourse | Month 3 | 60.00 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EHP-30 Scores Over Time: Social Support | Month 3 | 17.19 score on a scale | Standard Deviation 11.831 |
| Group A | EHP-30 Scores Over Time: Social Support | Baseline | 48.21 score on a scale | Standard Deviation 21.565 |
| Group B | EHP-30 Scores Over Time: Social Support | Month 6 | 25.00 score on a scale | — |
| Group B | EHP-30 Scores Over Time: Social Support | Month 3 | 16.67 score on a scale | Standard Deviation 28.868 |
| Group B | EHP-30 Scores Over Time: Social Support | Baseline | 45.83 score on a scale | Standard Deviation 19.094 |
| Group C | EHP-30 Scores Over Time: Social Support | Baseline | 50.00 score on a scale | — |
| Group C | EHP-30 Scores Over Time: Social Support | Month 3 | 18.75 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | Month 3 | 38.07 score on a scale | Standard Deviation 26.529 |
| Group A | Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | Baseline | 59.42 score on a scale | Standard Deviation 11.694 |
| Group B | Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | Month 6 | 27.27 score on a scale | — |
| Group B | Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | Month 3 | 17.42 score on a scale | Standard Deviation 22.422 |
| Group B | Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | Baseline | 47.73 score on a scale | Standard Deviation 14.193 |
| Group C | Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | Baseline | 59.09 score on a scale | — |
| Group C | Endometriosis Health Profile-30 (EHP-30) Scores Over Time: Pain | Month 3 | 38.64 score on a scale | — |
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).
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EQ-5D-5L Scores Over Time: Anxiety/Depression | Month 3 | 1.0 score on a scale | Standard Deviation 0 |
| Group A | EQ-5D-5L Scores Over Time: Anxiety/Depression | Baseline | 1.0 score on a scale | Standard Deviation 0 |
| Group B | EQ-5D-5L Scores Over Time: Anxiety/Depression | Month 6 | 1.0 score on a scale | — |
| Group B | EQ-5D-5L Scores Over Time: Anxiety/Depression | Month 3 | 1.0 score on a scale | Standard Deviation 0 |
| Group B | EQ-5D-5L Scores Over Time: Anxiety/Depression | Baseline | 1.3 score on a scale | Standard Deviation 0.58 |
| Group C | EQ-5D-5L Scores Over Time: Anxiety/Depression | Baseline | 1.0 score on a scale | — |
| Group C | EQ-5D-5L Scores Over Time: Anxiety/Depression | Month 3 | 1.0 score on a scale | — |
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).
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EQ-5D-5L Scores Over Time: Pain/Discomfort | Month 3 | 2.0 score on a scale | Standard Deviation 1.15 |
| Group A | EQ-5D-5L Scores Over Time: Pain/Discomfort | Baseline | 2.7 score on a scale | Standard Deviation 0.76 |
| Group B | EQ-5D-5L Scores Over Time: Pain/Discomfort | Month 6 | 1.0 score on a scale | — |
| Group B | EQ-5D-5L Scores Over Time: Pain/Discomfort | Month 3 | 1.7 score on a scale | Standard Deviation 0.58 |
| Group B | EQ-5D-5L Scores Over Time: Pain/Discomfort | Baseline | 2.7 score on a scale | Standard Deviation 0.58 |
| Group C | EQ-5D-5L Scores Over Time: Pain/Discomfort | Baseline | 4.0 score on a scale | — |
| Group C | EQ-5D-5L Scores Over Time: Pain/Discomfort | Month 3 | 3.0 score on a scale | — |
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).
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EQ-5D-5L Scores Over Time: Self-Care | Month 3 | 1.0 score on a scale | Standard Deviation 0 |
| Group A | EQ-5D-5L Scores Over Time: Self-Care | Baseline | 1.0 score on a scale | Standard Deviation 0 |
| Group B | EQ-5D-5L Scores Over Time: Self-Care | Month 6 | 1.0 score on a scale | — |
| Group B | EQ-5D-5L Scores Over Time: Self-Care | Month 3 | 1.0 score on a scale | Standard Deviation 0 |
| Group B | EQ-5D-5L Scores Over Time: Self-Care | Baseline | 1.0 score on a scale | Standard Deviation 0 |
| Group C | EQ-5D-5L Scores Over Time: Self-Care | Baseline | 1.0 score on a scale | — |
| Group C | EQ-5D-5L Scores Over Time: Self-Care | Month 3 | 1.0 score on a scale | — |
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).
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EQ-5D-5L Scores Over Time: Usual Activities | Month 3 | 1.5 score on a scale | Standard Deviation 0.58 |
| Group A | EQ-5D-5L Scores Over Time: Usual Activities | Baseline | 2.0 score on a scale | Standard Deviation 0.82 |
| Group B | EQ-5D-5L Scores Over Time: Usual Activities | Month 6 | 1.0 score on a scale | — |
| Group B | EQ-5D-5L Scores Over Time: Usual Activities | Month 3 | 1.7 score on a scale | Standard Deviation 1.15 |
| Group B | EQ-5D-5L Scores Over Time: Usual Activities | Baseline | 1.3 score on a scale | Standard Deviation 0.58 |
| Group C | EQ-5D-5L Scores Over Time: Usual Activities | Baseline | 1.0 score on a scale | — |
| Group C | EQ-5D-5L Scores Over Time: Usual Activities | Month 3 | 2.0 score on a scale | — |
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).
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EQ-5D-5L VAS Scores Over Time: Health Today | Month 3 | 72.8 score on a scale | Standard Deviation 17.63 |
| Group A | EQ-5D-5L VAS Scores Over Time: Health Today | Baseline | 79.7 score on a scale | Standard Deviation 15.16 |
| Group B | EQ-5D-5L VAS Scores Over Time: Health Today | Month 6 | 94.0 score on a scale | — |
| Group B | EQ-5D-5L VAS Scores Over Time: Health Today | Month 3 | 85.0 score on a scale | Standard Deviation 15 |
| Group B | EQ-5D-5L VAS Scores Over Time: Health Today | Baseline | 53.3 score on a scale | Standard Deviation 35.12 |
| Group C | EQ-5D-5L VAS Scores Over Time: Health Today | Baseline | 72.0 score on a scale | — |
| Group C | EQ-5D-5L VAS Scores Over Time: Health Today | Month 3 | 70.0 score on a scale | — |
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).
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | Month 3 | 1.3 score on a scale | Standard Deviation 0.5 |
| Group A | EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | Baseline | 1.4 score on a scale | Standard Deviation 0.53 |
| Group B | EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | Month 6 | 1.0 score on a scale | — |
| Group B | EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | Month 3 | 1.0 score on a scale | Standard Deviation 0 |
| Group B | EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | Baseline | 1.0 score on a scale | Standard Deviation 0 |
| Group C | EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | Baseline | 1.0 score on a scale | — |
| Group C | EuroQol-5D 5 Level (EQ-5D-5L) Scores Over Time: Mobility | Month 3 | 2.0 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 3, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | Month 3 | 22.25 score on a scale | Standard Deviation 9.43 |
| Group A | Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | Baseline | 19.71 score on a scale | Standard Deviation 4.536 |
| Group B | Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | Month 6 | 31.00 score on a scale | — |
| Group B | Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | Month 3 | 25.47 score on a scale | Standard Deviation 6.652 |
| Group B | Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | Baseline | 18.00 score on a scale | Standard Deviation 0 |
| Group C | Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | Baseline | 18.00 score on a scale | — |
| Group C | Health Endometriosis Treatment Satisfaction Questionnaire (ETSQ) Scores Over Time | Month 3 | 25.00 score on a scale | — |
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.
Time frame: Months 1, 2, 3, 4, 5, 6
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 1: Responder | 5 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 1: Non-Responder | 2 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 2: Responder | 4 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 2: Non-Responder | 1 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 3: Responder | 2 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 3: Non-Responder | 0 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 4: Responder | 1 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 4: Non-Responder | 0 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 5: Responder | 0 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 5: Non-Responder | 0 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 6: Responder | 0 Participants |
| Group A | Number of Analgesic Use Responders and Non-Responders Over Time | Month 6: Non-Responder | 0 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 6: Non-Responder | 2 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 1: Responder | 2 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 4: Responder | 2 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 5: Responder | 2 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 1: Non-Responder | 1 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 3: Non-Responder | 2 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 6: Responder | 0 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 2: Responder | 2 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 4: Non-Responder | 1 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 3: Responder | 1 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 2: Non-Responder | 1 Participants |
| Group B | Number of Analgesic Use Responders and Non-Responders Over Time | Month 5: Non-Responder | 1 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 2: Non-Responder | 0 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 3: Responder | 1 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 5: Non-Responder | 0 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 3: Non-Responder | 0 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 4: Responder | 1 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 4: Non-Responder | 0 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 6: Responder | 0 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 1: Responder | 1 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 1: Non-Responder | 0 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 5: Responder | 0 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 2: Responder | 1 Participants |
| Group C | Number of Analgesic Use Responders and Non-Responders Over Time | Month 6: Non-Responder | 0 Participants |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Baseline | 8.2 score on a scale | Standard Deviation 1.79 |
| Group A | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 3 | 9.0 score on a scale | — |
| Group A | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 2 | 4.5 score on a scale | Standard Deviation 0.71 |
| Group A | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 1 | 5.7 score on a scale | Standard Deviation 3.04 |
| Group B | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 6 | 4.0 score on a scale | — |
| Group B | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Baseline | 9.0 score on a scale | Standard Deviation 1 |
| Group B | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 1 | 7.7 score on a scale | Standard Deviation 1.15 |
| Group B | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 2 | 2.7 score on a scale | Standard Deviation 1.15 |
| Group B | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 3 | 5.3 score on a scale | Standard Deviation 2.31 |
| Group B | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 4 | 3.3 score on a scale | Standard Deviation 0.58 |
| Group B | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 5 | 8.0 score on a scale | Standard Deviation 0 |
| Group C | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 3 | 8.0 score on a scale | — |
| Group C | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Baseline | 7.0 score on a scale | — |
| Group C | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 2 | 5.0 score on a scale | — |
| Group C | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 1 | 8.0 score on a scale | — |
| Group C | Overall Endometriosis-Associated Pain Via NRS (7-Day Recall) Scores Over Time | Month 4 | 7.0 score on a scale | — |
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).
Time frame: Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Patient Global Impression of Change (PGIC) Scores Over Time | Month 1 | 2.9 score on a scale | Standard Deviation 1.35 |
| Group A | Patient Global Impression of Change (PGIC) Scores Over Time | Month 2 | 2.0 score on a scale | Standard Deviation 0 |
| Group A | Patient Global Impression of Change (PGIC) Scores Over Time | Month 3 | 2.0 score on a scale | — |
| Group B | Patient Global Impression of Change (PGIC) Scores Over Time | Month 4 | 2.0 score on a scale | Standard Deviation 1 |
| Group B | Patient Global Impression of Change (PGIC) Scores Over Time | Month 6 | 1.0 score on a scale | — |
| Group B | Patient Global Impression of Change (PGIC) Scores Over Time | Month 1 | 2.3 score on a scale | Standard Deviation 0.58 |
| Group B | Patient Global Impression of Change (PGIC) Scores Over Time | Month 5 | 2.5 score on a scale | Standard Deviation 0.71 |
| Group B | Patient Global Impression of Change (PGIC) Scores Over Time | Month 3 | 2.0 score on a scale | Standard Deviation 1 |
| Group B | Patient Global Impression of Change (PGIC) Scores Over Time | Month 2 | 1.3 score on a scale | Standard Deviation 0.58 |
| Group C | Patient Global Impression of Change (PGIC) Scores Over Time | Month 1 | 2.0 score on a scale | — |
| Group C | Patient Global Impression of Change (PGIC) Scores Over Time | Month 2 | 2.0 score on a scale | — |
| Group C | Patient Global Impression of Change (PGIC) Scores Over Time | Month 3 | 5.0 score on a scale | — |
| Group C | Patient Global Impression of Change (PGIC) Scores Over Time | Month 4 | 2.0 score on a scale | — |
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.
Time frame: Month 6
Population: Participants with both baseline and post-baseline values for Daily Diary Endometriosis-Associated Pain Score via NRS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group B | 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 | 50.0 percentage of participants |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 1 | -14.10 percentage change of score on a scale | Standard Deviation 37.146 |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 4 | -70.98 percentage change of score on a scale | — |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 3 | -43.98 percentage change of score on a scale | Standard Deviation 35.509 |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 2 | -37.82 percentage change of score on a scale | Standard Deviation 18.066 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 6 | -33.56 percentage change of score on a scale | Standard Deviation 11.357 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 1 | -19.61 percentage change of score on a scale | Standard Deviation 35.468 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 2 | -56.25 percentage change of score on a scale | Standard Deviation 4.507 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 3 | -53.05 percentage change of score on a scale | Standard Deviation 13.803 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 4 | -38.00 percentage change of score on a scale | Standard Deviation 31.275 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 5 | -35.81 percentage change of score on a scale | Standard Deviation 9.326 |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 1 | -11.34 percentage change of score on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 4 | -14.34 percentage change of score on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 3 | -18.22 percentage change of score on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for Daily Diary Endometriosis-Associated Pain Score Via NRS | Percent Change at Month 2 | -18.99 percentage change of score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 4 | -80.00 percent change of units on a scale | — |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 3 | -62.92 percent change of units on a scale | Standard Deviation 24.159 |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 2 | -27.45 percent change of units on a scale | Standard Deviation 17.119 |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 1 | 1.67 percent change of units on a scale | Standard Deviation 109.961 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 4 | -16.67 percent change of units on a scale | — |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 5 | -40.48 percent change of units on a scale | Standard Deviation 33.672 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 6 | -57.14 percent change of units on a scale | — |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 1 | -7.89 percent change of units on a scale | — |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 2 | -75.00 percent change of units on a scale | — |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for DYS | Percent Change at Month 3 | -85.71 percent change of units on a scale | — |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 1 | 0.14 percentage change of units on a scale | Standard Deviation 18.18 |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 4 | 106.25 percentage change of units on a scale | — |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 3 | 60.88 percentage change of units on a scale | Standard Deviation 65.632 |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 2 | 6.60 percentage change of units on a scale | Standard Deviation 15.719 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 6 | -18.08 percentage change of units on a scale | Standard Deviation 25.571 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 1 | -15.27 percentage change of units on a scale | Standard Deviation 26.791 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 2 | -15.26 percentage change of units on a scale | Standard Deviation 21.84 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 3 | -21.63 percentage change of units on a scale | Standard Deviation 24.719 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 4 | -12.67 percentage change of units on a scale | Standard Deviation 20.433 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 5 | -14.86 percentage change of units on a scale | Standard Deviation 16.002 |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 1 | -9.52 percentage change of units on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 4 | -0.95 percentage change of units on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 3 | -0.95 percentage change of units on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for Dyspareunia | Percent Change at Month 2 | -12.38 percentage change of units on a scale | — |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: Participants with an assessment at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 1 | -11.81 percentage change of units on a scale | Standard Deviation 26.677 |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 4 | -71.21 percentage change of units on a scale | — |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 3 | -38.26 percentage change of units on a scale | Standard Deviation 42.319 |
| Group A | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 2 | -37.53 percentage change of units on a scale | Standard Deviation 31.15 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 6 | -17.23 percentage change of units on a scale | Standard Deviation 16.044 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 1 | 4.22 percentage change of units on a scale | Standard Deviation 53.238 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 2 | -34.21 percentage change of units on a scale | Standard Deviation 18.044 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 3 | -38.03 percentage change of units on a scale | Standard Deviation 20.343 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 4 | -44.49 percentage change of units on a scale | Standard Deviation 20.725 |
| Group B | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 5 | -28.40 percentage change of units on a scale | Standard Deviation 33.641 |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 1 | 16.07 percentage change of units on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 4 | 19.05 percentage change of units on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 3 | 22.62 percentage change of units on a scale | — |
| Group C | Percent Change From Baseline to Each Month During the Treatment Period for NMPP | Percent Change at Month 2 | 11.90 percentage change of units on a scale | — |
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).
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | PROMIS Fatigue Short Form 6a Scores Over Time | Baseline | 22.1 score on a scale | Standard Deviation 4.1 |
| Group A | PROMIS Fatigue Short Form 6a Scores Over Time | Month 6 | 15.3 score on a scale | Standard Deviation 7.77 |
| Group B | PROMIS Fatigue Short Form 6a Scores Over Time | Baseline | 19.3 score on a scale | Standard Deviation 6.11 |
| Group B | PROMIS Fatigue Short Form 6a Scores Over Time | Month 6 | 11.0 score on a scale | — |
| Group C | PROMIS Fatigue Short Form 6a Scores Over Time | Baseline | 27.0 score on a scale | — |
| Group C | PROMIS Fatigue Short Form 6a Scores Over Time | Month 6 | 21.0 score on a scale | — |
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: 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.
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.
Time frame: Month 0 (baseline), Months 1, 2, 3, 4, 5, 6
Population: 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.
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem | Baseline | 0.16 percent of work time missed | Standard Deviation 0.205 |
| Group A | Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem | Month 6 | 0.00 percent of work time missed | Standard Deviation 0 |
| Group B | Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem | Baseline | 0.08 percent of work time missed | Standard Deviation 0.144 |
| Group B | Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) Scores Over Time: Percent Work Missed Due to Problem | Month 6 | 0.00 percent of work time missed | — |
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem | Baseline | 0.66 percentage impairment of activity | Standard Deviation 0.237 |
| Group A | WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem | Month 6 | 0.40 percentage impairment of activity | Standard Deviation 0.346 |
| Group B | WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem | Baseline | 0.67 percentage impairment of activity | Standard Deviation 0.058 |
| Group B | WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem | Month 6 | 0.30 percentage impairment of activity | — |
| Group C | WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem | Baseline | 0.70 percentage impairment of activity | — |
| Group C | WPAI:SHP Scores Over Time: Percent Activity Impairment Due to Problem | Month 6 | 0.70 percentage impairment of activity | — |
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem | Baseline | 0.57 percent impairment while working | Standard Deviation 0.273 |
| Group A | WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem | Month 6 | 0.30 percent impairment while working | Standard Deviation 0.265 |
| Group B | WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem | Baseline | 0.53 percent impairment while working | Standard Deviation 0.153 |
| Group B | WPAI:SHP Scores Over Time: Percent Impairment While Working Due to Problem | Month 6 | 0.30 percent impairment while working | — |
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.
Time frame: Month 0 (baseline), Month 6
Population: Participants with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A | WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem | Baseline | 0.61 percent overall work impairment | Standard Deviation 0.307 |
| Group A | WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem | Month 6 | 0.30 percent overall work impairment | Standard Deviation 0.265 |
| Group B | WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem | Baseline | 0.56 percent overall work impairment | Standard Deviation 0.194 |
| Group B | WPAI:SHP Scores Over Time: Percent Overall Work Impairment Due to Problem | Month 6 | 0.30 percent overall work impairment | — |