Endometriosis
Conditions
Keywords
Endometriosis associated pain, Elagolix, Gonadotropin-Releasing Hormone Antagonist, Dysmenorrhea (DYS), Non-Menstrual Pelvic Pain (NMPP)
Brief summary
A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in pre-menopausal women.
Detailed description
This is a Phase 3 multicenter, double blind randomized study to assess the continued safety and efficacy of the 150 mg once daily (QD) and 200 mg twice daily (BID) doses of elagolix in premenopausal women with moderate to severe endometriosis-associated pain who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months. Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg QD or elagolix 200 mg BID for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months. An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis. All participants who prematurely discontinued treatment (unless pregnant or elected surgery for endometriosis) or completed the 6-month Treatment Period in this extension study were to enter the Post-treatment Follow-up (PTFU) Period within this study for up to 12 months.
Interventions
DRUGElagolix
Elagolix tablets administered orally
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 50 Years
Healthy volunteers
No
Inclusion criteria
* Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528) * Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period
Exclusion criteria
* Clinically significant gynecological condition * Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip * Plans to become pregnant in the next 18 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6 | Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit. |
| Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6 | Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6 | Response was defined as a reduction of -0.36 or more from baseline in dyspareunia (pain during sexual intercourse) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesics). Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed dyspareunia each day in an e-Diary. Dyspareunia was assessed according to the following: * 0: None; No discomfort during sexual intercourse * 1: Mild; Able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; Avoided intercourse because of pain * Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores and analgesic use were averaged over the 35 days prior to each visit. Responses of Not Applicable were excluded. |
| Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6 | Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit. |
| Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6 | Participants assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit. |
| Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6 | Participants assessed dyspareunia each day in an e-Diary according to the following response options: * 0: None; No discomfort during sexual intercourse * 1: Mild; Able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; Avoided intercourse because of pain * Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of Not Applicable were excluded. |
| Change From Baseline in Any Rescue Analgesic Use | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6 | Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Any rescue analgesic use (NSAID and/or opioid) was calculated as the total number of pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day. |
| Change From Baseline in NSAID Rescue Analgesic Use | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6 | Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. NSAID rescue analgesic use was calculated as the total number of NSAID pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day. |
| Change From Baseline in Opioid Rescue Analgesic Use | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6 | Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Opioid rescue analgesic use was calculated as the total number of opioid pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day. |
| Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5 | Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain daily and dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. Dysmenorrhea was assessed according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit. |
| Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Months 1, 2, 3, 4, 5, and 6 | The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories: 1. Very Much Improved 2. Much Improved 3. Minimally Improved 4. Not Changed 5. Minimally Worse 6. Much Worse 7. Very Much Worse |
| Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6 | The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and includes pain, control and powerlessness, emotional well-being, social support, and self-image, and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis. Each question in the core questionnaire is scored on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always. The pain dimension consists of 11 questions. The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life. |
| Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6 | The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis; only 1 modular questionnaire (sexual intercourse \[5 items\]) was used in this study. The Sexual Intercourse dimension consists of 5 questions, each answered on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always, or Not Applicable (not scored). The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life. |
| Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and month 6 | The HRPQ consists of 9 questions measuring the impact of endometriosis-associated pain and its treatment on work productivity and daily activities in the home. Absenteeism: Number of hours of intended work lost due to illness or treatment. Presenteeism: Number of hours of work where output was impacted by illness or treatments. Total hours lost is the sum of hours missed due to absenteeism plus presenteeism. |
| Number of Participants With Non-study Health Visits During the Treatment Period | 6 months | The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study. |
| Number of Days in Hospital During the Treatment Period | 6 months | The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study, including physician visits, hospitalizations and types of procedures received. |
| Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6 | The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Participants were asked to assess their endometriosis pain over the past 24 hours at it's worst at approximately the same time every day in the e-Diary. Pain scores were averaged over the 35 days prior to each visit. |
| Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5 | Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit. |
Participant flow
Recruitment details
Participants who completed the 6-month Treatment Period in the pivotal Study M12-665 (NCT01620528) were eligible to enter this extension study. A total of 506 participants were enrolled at 131 sites in the United States, Puerto Rico, and Canada. Two enrolled participants did not receive study drug and are not included in the tables reported below.
Pre-assignment details
The study consisted of a 6-month Treatment Period and a Post-treatment Follow-up (PTFU) of up to 12 months. Participants who received elagolix in the pivotal study continued to receive the same dose for a further 6 months; participants on placebo in the pivotal study were randomized 1:1 to either elagolix 150 mg once daily or 200 mg twice daily.
Participants by arm
| Arm | Count |
|---|---|
| Elagolix/Elagolix 150 mg QD Participants were randomized to elagolix 150 mg once a day (QD) in pivotal Study M12-665 and continued to receive elagolix 150 mg QD for 6 months in this extension Study M12-667. | 149 |
| Elagolix/Elagolix 200 mg BID Participants were randomized to elagolix 200 mg twice a day (BID) in pivotal Study M12-665 and continued to receive elagolix 200 mg BID for 6 months in this extension Study M12-667. | 138 |
| Placebo/Elagolix 150 mg QD Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 150 mg QD for 6 months in this extension Study M12-667. | 108 |
| Placebo/Elagolix 200 mg BID Participants who received placebo in pivotal Study M12-665 and were randomized to elagolix 200 mg BID for 6 months in this extension Study M12-667. | 109 |
| Total | 504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Post-treatment Follow-up (12 Months) | Lost to Follow-up | 4 | 7 | 2 | 0 |
| Post-treatment Follow-up (12 Months) | Other | 13 | 8 | 9 | 6 |
| Post-treatment Follow-up (12 Months) | Received Exclusionary Medication | 1 | 4 | 0 | 0 |
| Post-treatment Follow-up (12 Months) | Return of Menses and Acceptable BMD | 0 | 0 | 1 | 0 |
| Post-treatment Follow-up (12 Months) | Surgery or invasive intervention | 6 | 10 | 5 | 5 |
| Post-treatment Follow-up (12 Months) | Withdrawal by Subject | 6 | 6 | 4 | 9 |
| Treatment Period (6 Months) | Adverse Event | 5 | 3 | 4 | 10 |
| Treatment Period (6 Months) | Decrease in Bone Mineral Density (BMD) | 1 | 6 | 0 | 0 |
| Treatment Period (6 Months) | Exclusionary Medication | 1 | 0 | 0 | 0 |
| Treatment Period (6 Months) | Lost to Follow-up | 9 | 1 | 4 | 3 |
| Treatment Period (6 Months) | Non-compliance | 1 | 4 | 0 | 3 |
| Treatment Period (6 Months) | Other | 0 | 3 | 3 | 1 |
| Treatment Period (6 Months) | Pregnancy | 5 | 0 | 3 | 2 |
| Treatment Period (6 Months) | Surgery or invasive intervention for end | 3 | 3 | 3 | 2 |
| Treatment Period (6 Months) | Withdrawal by Subject | 8 | 8 | 4 | 5 |
Baseline characteristics
| Characteristic | Elagolix/Elagolix 150 mg QD | Elagolix/Elagolix 200 mg BID | Placebo/Elagolix 150 mg QD | Placebo/Elagolix 200 mg BID | Total |
|---|---|---|---|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 6.52 | 31.3 years STANDARD_DEVIATION 6.32 | 32.4 years STANDARD_DEVIATION 6.08 | 32.2 years STANDARD_DEVIATION 6.38 | 31.9 years STANDARD_DEVIATION 6.34 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 21 Participants | 19 Participants | 22 Participants | 85 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 126 Participants | 117 Participants | 89 Participants | 87 Participants | 419 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 9 Participants | 8 Participants | 12 Participants | 41 Participants |
| Race/Ethnicity, Customized Multi race | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 8 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 133 Participants | 126 Participants | 96 Participants | 95 Participants | 450 Participants |
| Sex: Female, Male Female | 149 Participants | 138 Participants | 108 Participants | 109 Participants | 504 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 149 | 0 / 138 | 0 / 108 | 0 / 109 |
| other Total, other adverse events | 79 / 149 | 74 / 138 | 55 / 108 | 68 / 109 |
| serious Total, serious adverse events | 5 / 149 | 4 / 138 | 5 / 108 | 5 / 109 |
Outcome results
Primary
Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment
Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea (pain during menstruation) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic use for endometriosis-associated pain daily and dysmenorrhea and its impact on daily activities each day of their period in an electronic diary (e-Diary). Dysmenorrhea was assessed according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment | 52.1 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment | 78.2 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment | 32.6 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Month 6 Based on Daily Assessment | 64.4 percentage of participants |
Primary
Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment
Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and Month 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline and month 6 data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment | 67.5 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment | 69.1 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment | 39.5 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Month 6 Based on Daily Assessment | 57.5 percentage of participants |
Secondary
Change From Baseline in Any Rescue Analgesic Use
Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Any rescue analgesic use (NSAID and/or opioid) was calculated as the total number of pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 1 | -0.35 pills/day | Standard Deviation 0.743 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 2 | -0.35 pills/day | Standard Deviation 0.646 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 3 | -0.37 pills/day | Standard Deviation 0.733 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 4 | -0.40 pills/day | Standard Deviation 0.703 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 5 | -0.41 pills/day | Standard Deviation 0.687 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 6 | -0.40 pills/day | Standard Deviation 0.699 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 6 | -0.56 pills/day | Standard Deviation 0.667 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 4 | -0.62 pills/day | Standard Deviation 0.697 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 1 | -0.58 pills/day | Standard Deviation 0.687 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 3 | -0.61 pills/day | Standard Deviation 0.785 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 2 | -0.59 pills/day | Standard Deviation 0.735 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 5 | -0.59 pills/day | Standard Deviation 0.685 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 2 | -0.24 pills/day | Standard Deviation 0.471 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 3 | -0.25 pills/day | Standard Deviation 0.525 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 4 | -0.26 pills/day | Standard Deviation 0.521 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 6 | -0.22 pills/day | Standard Deviation 0.616 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 5 | -0.27 pills/day | Standard Deviation 0.626 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Any Rescue Analgesic Use | Month 1 | -0.15 pills/day | Standard Deviation 0.398 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 5 | -0.34 pills/day | Standard Deviation 0.59 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 6 | -0.38 pills/day | Standard Deviation 0.602 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 2 | -0.28 pills/day | Standard Deviation 0.481 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 4 | -0.35 pills/day | Standard Deviation 0.616 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 1 | -0.16 pills/day | Standard Deviation 0.486 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Any Rescue Analgesic Use | Month 3 | -0.32 pills/day | Standard Deviation 0.47 |
Secondary
Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension
The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and includes pain, control and powerlessness, emotional well-being, social support, and self-image, and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis. Each question in the core questionnaire is scored on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always. The pain dimension consists of 11 questions. The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 1 | -29.50 units on a scale | Standard Deviation 20.917 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 6 | -31.18 units on a scale | Standard Deviation 22.213 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 3 | -30.10 units on a scale | Standard Deviation 20.231 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 1 | -40.28 units on a scale | Standard Deviation 21.503 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 6 | -41.62 units on a scale | Standard Deviation 21.553 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 3 | -43.16 units on a scale | Standard Deviation 20.951 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 3 | -17.87 units on a scale | Standard Deviation 21.16 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 1 | -12.98 units on a scale | Standard Deviation 17.426 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 6 | -15.63 units on a scale | Standard Deviation 22.676 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 1 | -13.27 units on a scale | Standard Deviation 17.01 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 6 | -25.17 units on a scale | Standard Deviation 23.387 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Pain Dimension | Month 3 | -21.87 units on a scale | Standard Deviation 24.087 |
Secondary
Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension
The EHP-30 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-30 consists of two parts: a core questionnaire containing 5 scales that are applicable to all women with endometriosis and a modular part containing 6 scales which do not necessarily apply to all women with endometriosis; only 1 modular questionnaire (sexual intercourse \[5 items\]) was used in this study. The Sexual Intercourse dimension consists of 5 questions, each answered on the following scale: 0 = Never, 1 = Rarely, 2 = Sometimes, 3 = Often, 4 = Always, or Not Applicable (not scored). The dimension score ranges from 0 to 100, where 0 = best possible health status as measured by the questionnaire; 100 = worst possible health status. A negative change from baseline score indicates improvement in quality of life.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 3, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 1 | -19.81 units on a scale | Standard Deviation 23.828 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 6 | -24.23 units on a scale | Standard Deviation 27.065 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 3 | -20.88 units on a scale | Standard Deviation 24.979 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 1 | -29.42 units on a scale | Standard Deviation 28.257 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 6 | -30.55 units on a scale | Standard Deviation 33.831 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 3 | -27.27 units on a scale | Standard Deviation 30.431 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 3 | -15.00 units on a scale | Standard Deviation 22.89 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 1 | -8.15 units on a scale | Standard Deviation 21.287 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 6 | -12.45 units on a scale | Standard Deviation 26.858 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 1 | -9.86 units on a scale | Standard Deviation 17.484 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 6 | -23.17 units on a scale | Standard Deviation 25.763 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Endometriosis Health Profile-30 (EHP-30) Sexual Intercourse Dimension | Month 3 | -18.24 units on a scale | Standard Deviation 23.015 |
Secondary
Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household
The HRPQ consists of 9 questions measuring the impact of endometriosis-associated pain and its treatment on work productivity and daily activities in the home. Absenteeism: Number of hours of intended work lost due to illness or treatment. Presenteeism: Number of hours of work where output was impacted by illness or treatments. Total hours lost is the sum of hours missed due to absenteeism plus presenteeism.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and month 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point. Hours lost from workplace were only calculated for participants who were employed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Absenteeism from workplace | -1.84 hours | Standard Deviation 5.636 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Presenteeism from workplace | -11.14 hours | Standard Deviation 8.484 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Total hours of work lost from workplace | -12.98 hours | Standard Deviation 9.662 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Absenteeism from household | -3.10 hours | Standard Deviation 7.588 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Presenteeism from household | -2.72 hours | Standard Deviation 6.459 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Total hours of work lost from household | -5.82 hours | Standard Deviation 11.356 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Total hours of work lost from household | -6.15 hours | Standard Deviation 7.628 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Absenteeism from household | -3.69 hours | Standard Deviation 4.486 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Absenteeism from workplace | -3.01 hours | Standard Deviation 6.771 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Total hours of work lost from workplace | -15.15 hours | Standard Deviation 11.653 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Presenteeism from workplace | -12.45 hours | Standard Deviation 10.464 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Presenteeism from household | -2.49 hours | Standard Deviation 4.531 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Presenteeism from workplace | -8.29 hours | Standard Deviation 8.307 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Total hours of work lost from workplace | -10.44 hours | Standard Deviation 9.422 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Absenteeism from household | -3.76 hours | Standard Deviation 7.457 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Total hours of work lost from household | -6.90 hours | Standard Deviation 11.673 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Presenteeism from household | -2.95 hours | Standard Deviation 4.793 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Absenteeism from workplace | -2.15 hours | Standard Deviation 4.258 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Presenteeism from household | -2.72 hours | Standard Deviation 4.698 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Total hours of work lost from household | -5.52 hours | Standard Deviation 6.934 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Presenteeism from workplace | -10.15 hours | Standard Deviation 10.724 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Absenteeism from household | -2.80 hours | Standard Deviation 4.971 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Absenteeism from workplace | -2.78 hours | Standard Deviation 4.73 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Health-Related Productivity Questionnaire (HRPQ): Hours of Work Lost in Workplace and Household | Total hours of work lost from workplace | -13.03 hours | Standard Deviation 11.911 |
Secondary
Change From Baseline in NSAID Rescue Analgesic Use
Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. NSAID rescue analgesic use was calculated as the total number of NSAID pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 5 | -0.27 pills/day | Standard Deviation 0.494 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 6 | -0.27 pills/day | Standard Deviation 0.517 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 3 | -0.24 pills/day | Standard Deviation 0.488 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 1 | -0.24 pills/day | Standard Deviation 0.484 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 2 | -0.24 pills/day | Standard Deviation 0.472 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 4 | -0.25 pills/day | Standard Deviation 0.461 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 5 | -0.32 pills/day | Standard Deviation 0.417 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 4 | -0.35 pills/day | Standard Deviation 0.45 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 6 | -0.31 pills/day | Standard Deviation 0.43 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 2 | -0.34 pills/day | Standard Deviation 0.462 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 3 | -0.34 pills/day | Standard Deviation 0.46 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 1 | -0.34 pills/day | Standard Deviation 0.469 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 2 | -0.12 pills/day | Standard Deviation 0.302 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 1 | -0.07 pills/day | Standard Deviation 0.217 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 3 | -0.12 pills/day | Standard Deviation 0.324 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 4 | -0.13 pills/day | Standard Deviation 0.336 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 5 | -0.13 pills/day | Standard Deviation 0.378 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in NSAID Rescue Analgesic Use | Month 6 | -0.12 pills/day | Standard Deviation 0.38 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 6 | -0.23 pills/day | Standard Deviation 0.453 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 5 | -0.17 pills/day | Standard Deviation 0.394 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 2 | -0.14 pills/day | Standard Deviation 0.311 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 1 | -0.09 pills/day | Standard Deviation 0.314 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 4 | -0.17 pills/day | Standard Deviation 0.397 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in NSAID Rescue Analgesic Use | Month 3 | -0.14 pills/day | Standard Deviation 0.346 |
Secondary
Change From Baseline in Opioid Rescue Analgesic Use
Permitted rescue analgesics varied by country and were limited to non-steroidal anti-inflammatory drugs (NSAID) (naproxen 500 mg), or opioid analgesics (hydrocodone 5 mg + acetaminophen 300 mg or 325 mg, and/or codeine 30 mg + acetaminophen 300 mg). Use of rescue analgesic medications taken for endometriosis-associated pain was recorded by the participant daily in the e-Diary as the total number of pills/tablets of each type taken within a 24-hour period. Opioid rescue analgesic use was calculated as the total number of opioid pills divided by the number of days in the window (i.e. average daily pill count) over the 35-day window prior to and including the reference study day.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 1 | -0.11 pills/day | Standard Deviation 0.547 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 4 | -0.15 pills/day | Standard Deviation 0.541 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 6 | -0.13 pills/day | Standard Deviation 0.439 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 2 | -0.11 pills/day | Standard Deviation 0.441 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 5 | -0.15 pills/day | Standard Deviation 0.469 |
| Elagolix/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 3 | -0.13 pills/day | Standard Deviation 0.54 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 5 | -0.27 pills/day | Standard Deviation 0.558 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 4 | -0.27 pills/day | Standard Deviation 0.581 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 2 | -0.25 pills/day | Standard Deviation 0.532 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 1 | -0.24 pills/day | Standard Deviation 0.469 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 6 | -0.25 pills/day | Standard Deviation 0.534 |
| Elagolix/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 3 | -0.28 pills/day | Standard Deviation 0.599 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 3 | -0.13 pills/day | Standard Deviation 0.298 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 1 | -0.09 pills/day | Standard Deviation 0.272 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 2 | -0.12 pills/day | Standard Deviation 0.267 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 4 | -0.13 pills/day | Standard Deviation 0.298 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 5 | -0.14 pills/day | Standard Deviation 0.384 |
| Placebo/Elagolix 150 mg QD | Change From Baseline in Opioid Rescue Analgesic Use | Month 6 | -0.10 pills/day | Standard Deviation 0.369 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 6 | -0.16 pills/day | Standard Deviation 0.392 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 5 | -0.17 pills/day | Standard Deviation 0.444 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 1 | -0.07 pills/day | Standard Deviation 0.329 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 3 | -0.17 pills/day | Standard Deviation 0.338 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 4 | -0.19 pills/day | Standard Deviation 0.501 |
| Placebo/Elagolix 200 mg BID | Change From Baseline in Opioid Rescue Analgesic Use | Month 2 | -0.14 pills/day | Standard Deviation 0.344 |
Secondary
Number of Days in Hospital During the Treatment Period
The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study, including physician visits, hospitalizations and types of procedures received.
Time frame: 6 months
Population: Participants who received at least 1 dose of double-blind study drug in this extension study and who underwent hospitalization
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Elagolix/Elagolix 150 mg QD | Number of Days in Hospital During the Treatment Period | 2.0 days |
| Elagolix/Elagolix 200 mg BID | Number of Days in Hospital During the Treatment Period | 1.5 days |
| Placebo/Elagolix 150 mg QD | Number of Days in Hospital During the Treatment Period | 3.0 days |
| Placebo/Elagolix 200 mg BID | Number of Days in Hospital During the Treatment Period | 1.0 days |
Secondary
Number of Participants With Non-study Health Visits During the Treatment Period
The Health Resource Use Questionnaire (HRUQ) was used to collect information on non-study-related health visits that participants had during the study.
Time frame: 6 months
Population: Participants who received at least 1 dose of double-blind study drug in this extension study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elagolix/Elagolix 150 mg QD | Number of Participants With Non-study Health Visits During the Treatment Period | 81 Participants |
| Elagolix/Elagolix 200 mg BID | Number of Participants With Non-study Health Visits During the Treatment Period | 68 Participants |
| Placebo/Elagolix 150 mg QD | Number of Participants With Non-study Health Visits During the Treatment Period | 59 Participants |
| Placebo/Elagolix 200 mg BID | Number of Participants With Non-study Health Visits During the Treatment Period | 48 Participants |
Secondary
Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved
The Patient Global Impression of Change (PGIC) is a questionnaire-based assessment of the change in endometriosis pain since the initiation of study drug. The participant was asked to select from one of seven response categories: 1. Very Much Improved 2. Much Improved 3. Minimally Improved 4. Not Changed 5. Minimally Worse 6. Much Worse 7. Very Much Worse
Time frame: Months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 2 | 64.7 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 1 | 63.3 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 4 | 70.7 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 6 | 69.4 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 3 | 64.3 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 5 | 75.2 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 6 | 91.2 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 5 | 87.5 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 2 | 87.3 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 3 | 87.4 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 1 | 86.4 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 4 | 91.5 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 2 | 65.7 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 3 | 73.7 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 4 | 73.9 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 5 | 66.3 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 6 | 70.4 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 1 | 47.1 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 1 | 45.5 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 6 | 79.3 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 3 | 71.3 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 2 | 70.0 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 5 | 78.7 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a PGIC Response of Much Improved or Very Much Improved | Month 4 | 70.8 percentage of participants |
Secondary
Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment
Response was defined as a reduction of -0.81 or more from baseline in dysmenorrhea as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesic). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain daily and dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. Dysmenorrhea was assessed according to the following: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Analgesic use and pain scores were averaged over the 35 days prior to each visit.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5
Population: Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 4 | 53.9 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 2 | 51.1 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 5 | 54.0 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 3 | 49.2 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 1 | 48.0 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 3 | 80.5 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 4 | 79.8 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 5 | 83.3 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 2 | 78.9 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 1 | 80.9 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 3 | 36.8 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 1 | 21.0 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 2 | 40.2 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 4 | 39.6 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 5 | 32.6 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 4 | 58.2 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 2 | 60.0 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 1 | 20.6 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 3 | 54.3 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dysmenorrhea at Each Month Based on Daily Assessment | Month 5 | 64.0 percentage of participants |
Secondary
Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment
Response was defined as a reduction of -0.36 or more from baseline in dyspareunia (pain during sexual intercourse) as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average rescue analgesic pill count and no additional analgesics). Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed dyspareunia each day in an e-Diary. Dyspareunia was assessed according to the following: * 0: None; No discomfort during sexual intercourse * 1: Mild; Able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; Avoided intercourse because of pain * Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores and analgesic use were averaged over the 35 days prior to each visit. Responses of Not Applicable were excluded.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point; if a participant's mean score was not defined because all reports in that month were Not Applicable, then that mean score was treated as missing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 1 | 50.0 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 2 | 51.9 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 3 | 50.0 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 4 | 48.9 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 5 | 46.6 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 6 | 45.2 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 6 | 60.0 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 4 | 65.3 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 1 | 61.3 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 3 | 63.8 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 2 | 58.3 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 5 | 65.3 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 2 | 35.8 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 3 | 36.4 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 4 | 46.9 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 6 | 39.0 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 5 | 38.1 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 1 | 33.3 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 5 | 39.7 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 6 | 43.1 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 2 | 30.0 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 4 | 41.9 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 1 | 15.6 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Dyspareunia at Each Month Based on Daily Assessment | Month 3 | 32.8 percentage of participants |
Secondary
Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment
Response was defined as a reduction of -0.36 or greater from baseline for non-menstrual pelvic pain as well as no increase in rescue analgesic use for endometriosis-associated pain (defined as a \< 15% increase in average pill count of rescue analgesics and no additional analgesics). The response threshold represents a clinically meaningful response that was determined in pivotal Study M12-665. Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores and analgesic use were averaged over the 35 days prior to each visit.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, and 5
Population: Participants who received at least 1 dose of double-blind study drug in this extension study and with available data at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 4 | 64.1 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 2 | 62.6 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 5 | 61.3 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 3 | 61.4 percentage of participants |
| Elagolix/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 1 | 55.4 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 3 | 70.7 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 4 | 75.6 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 5 | 71.9 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 2 | 69.5 percentage of participants |
| Elagolix/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 1 | 74.3 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 3 | 33.7 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 1 | 23.8 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 2 | 38.1 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 4 | 39.6 percentage of participants |
| Placebo/Elagolix 150 mg QD | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 5 | 40.4 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 4 | 47.3 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 2 | 41.0 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 1 | 29.0 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 3 | 45.7 percentage of participants |
| Placebo/Elagolix 200 mg BID | Percentage of Participants With a Response for Non-menstrual Pelvic Pain at Each Month Based on Daily Assessment | Month 5 | 51.7 percentage of participants |
Secondary
Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment
Participants assessed dysmenorrhea (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 1 | -46.7 percent change | Standard Deviation 44 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 2 | -46.7 percent change | Standard Deviation 44.93 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 3 | -47.9 percent change | Standard Deviation 42.37 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 4 | -51.4 percent change | Standard Deviation 44.65 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 5 | -52.4 percent change | Standard Deviation 43.55 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 6 | -49.2 percent change | Standard Deviation 43.75 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 6 | -82.0 percent change | Standard Deviation 33.29 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 4 | -85.1 percent change | Standard Deviation 30.52 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 1 | -82.7 percent change | Standard Deviation 34.81 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 3 | -84.5 percent change | Standard Deviation 33.24 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 2 | -84.8 percent change | Standard Deviation 29.81 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 5 | -83.4 percent change | Standard Deviation 31.19 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 2 | -46.6 percent change | Standard Deviation 47.39 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 3 | -36.3 percent change | Standard Deviation 57.28 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 4 | -38.2 percent change | Standard Deviation 52.48 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 6 | -37.9 percent change | Standard Deviation 47.43 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 5 | -33.4 percent change | Standard Deviation 48.29 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 1 | -19.0 percent change | Standard Deviation 50.35 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 5 | -77.2 percent change | Standard Deviation 41.9 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 6 | -71.6 percent change | Standard Deviation 47.81 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 2 | -67.3 percent change | Standard Deviation 47.74 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 4 | -67.4 percent change | Standard Deviation 47.8 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 1 | -19.3 percent change | Standard Deviation 51.09 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dysmenorrhea Based on Daily Assessment | Month 3 | -65.9 percent change | Standard Deviation 47.17 |
Secondary
Percent Change From Baseline in Dyspareunia Based on Daily Assessment
Participants assessed dyspareunia each day in an e-Diary according to the following response options: * 0: None; No discomfort during sexual intercourse * 1: Mild; Able to tolerate the discomfort during sexual intercourse * 2: Moderate; Intercourse was interrupted due to pain * 3: Severe; Avoided intercourse because of pain * Not applicable; I was not sexually active for reasons other than endometriosis or did not have sexual intercourse. Pain scores were averaged over the 35 days prior to each visit. Responses of Not Applicable were excluded.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study and with available baseline data and data at each time point; participants with responses of 'Not Applicable' on all reported days during baseline or for the entire time point were excluded from the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 1 | -32.8 percent change | Standard Deviation 63.13 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 2 | -36.2 percent change | Standard Deviation 56.97 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 3 | -36.1 percent change | Standard Deviation 55.41 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 4 | -35.0 percent change | Standard Deviation 55.27 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 5 | -34.9 percent change | Standard Deviation 58.9 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 6 | -30.7 percent change | Standard Deviation 66.57 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 6 | -41.7 percent change | Standard Deviation 68.5 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 4 | -48.6 percent change | Standard Deviation 63.81 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 1 | -39.5 percent change | Standard Deviation 71.3 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 3 | -38.6 percent change | Standard Deviation 75.34 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 2 | -40.4 percent change | Standard Deviation 63.27 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 5 | -44.8 percent change | Standard Deviation 76.01 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 2 | -16.2 percent change | Standard Deviation 82.49 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 3 | -14.1 percent change | Standard Deviation 76.54 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 4 | -24.3 percent change | Standard Deviation 76.26 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 6 | -28.0 percent change | Standard Deviation 66.59 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 5 | -20.2 percent change | Standard Deviation 62.92 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 1 | -12.9 percent change | Standard Deviation 62.92 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 5 | -27.5 percent change | Standard Deviation 58.78 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 6 | -12.6 percent change | Standard Deviation 107.83 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 2 | -27.1 percent change | Standard Deviation 48.17 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 4 | -20.7 percent change | Standard Deviation 71.89 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 1 | -1.1 percent change | Standard Deviation 63.74 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Dyspareunia Based on Daily Assessment | Month 3 | -23.5 percent change | Standard Deviation 50.71 |
Secondary
Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS)
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. Participants were asked to assess their endometriosis pain over the past 24 hours at it's worst at approximately the same time every day in the e-Diary. Pain scores were averaged over the 35 days prior to each visit.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study and with available baseline data and data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 1 | -41.0 percent change | Standard Deviation 39.85 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 2 | -44.4 percent change | Standard Deviation 38.35 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 3 | -45.5 percent change | Standard Deviation 36.23 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 4 | -47.7 percent change | Standard Deviation 37.99 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 5 | -46.4 percent change | Standard Deviation 38.07 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 6 | -48.2 percent change | Standard Deviation 38.97 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 6 | -60.7 percent change | Standard Deviation 36.09 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 4 | -63.5 percent change | Standard Deviation 32.93 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 1 | -60.0 percent change | Standard Deviation 36.93 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 3 | -62.2 percent change | Standard Deviation 34.1 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 2 | -62.1 percent change | Standard Deviation 33.8 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 5 | -62.1 percent change | Standard Deviation 34.56 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 2 | -31.2 percent change | Standard Deviation 39.22 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 3 | -28.0 percent change | Standard Deviation 55.94 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 4 | -32.8 percent change | Standard Deviation 57.74 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 6 | -27.8 percent change | Standard Deviation 64.75 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 5 | -29.0 percent change | Standard Deviation 71.65 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 1 | -9.2 percent change | Standard Deviation 81.63 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 5 | -46.4 percent change | Standard Deviation 39.07 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 6 | -45.5 percent change | Standard Deviation 44.1 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 2 | -34.6 percent change | Standard Deviation 41.07 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 4 | -40.0 percent change | Standard Deviation 54.65 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 1 | -22.3 percent change | Standard Deviation 34.41 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Endometriosis-Associated Pain Score Assessed With Numeric Rating Scale (NRS) | Month 3 | -39.9 percent change | Standard Deviation 41.48 |
Secondary
Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment
Participants assessed non-menstrual pelvic pain and its impact on their daily activities each day in an e-Diary according to the following response options: * 0: No discomfort * 1: Mild discomfort but I was easily able to do the things I usually do * 2: Moderate discomfort or pain that made it difficult to do some of the things I usually do * 3: Severe pain that made it difficult to do the things I usually do. Pain scores were averaged over the 35 days prior to each visit.
Time frame: Baseline (defined as baseline of Study M12-665 for participants who received elagolix in the pivotal study and baseline of the extension study M12-667 for participants who received placebo in the pivotal study) and months 1, 2, 3, 4, 5, and 6
Population: Participants who received at least 1 dose of double-blind study drug in this extension study with available baseline data and data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 1 | -37.4 percent change | Standard Deviation 43.9 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 2 | -41.4 percent change | Standard Deviation 41.49 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 3 | -44.0 percent change | Standard Deviation 40.44 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 4 | -47.2 percent change | Standard Deviation 41.3 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 5 | -45.3 percent change | Standard Deviation 41.05 |
| Elagolix/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 6 | -48.9 percent change | Standard Deviation 41.69 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 6 | -56.5 percent change | Standard Deviation 40.15 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 4 | -59.6 percent change | Standard Deviation 37.3 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 1 | -54.5 percent change | Standard Deviation 40.35 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 3 | -56.8 percent change | Standard Deviation 39.14 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 2 | -56.4 percent change | Standard Deviation 38.54 |
| Elagolix/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 5 | -58.0 percent change | Standard Deviation 39.18 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 2 | -22.6 percent change | Standard Deviation 85.6 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 3 | -19.7 percent change | Standard Deviation 93.18 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 4 | -32.0 percent change | Standard Deviation 66.23 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 6 | -10.2 percent change | Standard Deviation 163.42 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 5 | -17.7 percent change | Standard Deviation 126.45 |
| Placebo/Elagolix 150 mg QD | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 1 | -9.6 percent change | Standard Deviation 104.61 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 5 | -42.5 percent change | Standard Deviation 43.01 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 6 | -43.9 percent change | Standard Deviation 43.57 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 2 | -18.0 percent change | Standard Deviation 98.73 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 4 | -33.9 percent change | Standard Deviation 53.27 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 1 | -20.7 percent change | Standard Deviation 51.24 |
| Placebo/Elagolix 200 mg BID | Percent Change From Baseline in Non-menstrual Pelvic Pain Based on Daily Assessment | Month 3 | -30.2 percent change | Standard Deviation 57.07 |