A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

Phase 3

Completed

• Conditions: Endometriosis
• Interventions: Other: placebo; Drug: elagolix

• Registration Number: NCT01620528
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

A randomized study evaluating the safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants.

Detailed Description

This is a Phase 3, multicenter, double-blind, placebo-controlled, randomized study to assess the safety and efficacy of two doses of elagolix versus placebo in premenopausal 18 to 49 year old women with moderate to severe endometriosis-associated pain. The study consists of 4 periods: 1) Washout Period (if applicable); 2) a Screening Period of up to 100 days prior to first dose; 3) a 6 month Treatment Period; and 4) a Post treatment Follow-up Period of up to 12 months (if applicable). An electronic diary will be dispensed and training provided to record endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis-associated pain on a daily basis. Pregnancy testing will be performed monthly throughout the study.

Study Timeline

• Study First Submitted: 2012-05-15
• Study Start: 2012-05-22
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Primary Completion: 2014-11-14
• Study Completion: 2015-09-28
• Disposition First Submitted: 2015-11-13
• Disposition First Submitted QC: 2015-11-13
• Disposition First Posted: 2015-12-10
• Status Verified: 2017-03
• Results First Submitted: 2018-08-09
• Results First Submitted QC: 2018-09-14
• Last Update Submitted: 2018-09-14
• Results First Posted: 2018-09-18
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 872

Inclusion Criteria

1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of signing consent.
2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10 years of entry into Washout (if applicable) or Screening.
3. Agrees to use required birth control methods during the entire length of participation in the study.
4. Subject has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual pelvic pain. 5. Subjects must have at least two menstrual cycles 24 to 38 days within the Screening Period, prior to Day 1

Exclusion Criteria

1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24 months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the time of entry into the Screening Period.
2. Subject has a history of previous non-response to Gonadotropin-releasing hormone (GnRH) agonists, GnRH antagonists, Depot Medroxyprogesterone Acetate, or aromatase inhibitors as assessed by subject report of no improvement in dysmenorrhea or non-menstrual pelvic pain (subject report of partial response to or side effects from these agents is not exclusionary).
3. Subject has chronic pelvic pain that is not caused by endometriosis that requires chronic analgesic or other chronic therapy, or that would interfere with the assessment of endometriosis related pain.
4. Clinically significant gynecologic condition identified on Screening transvaginal ultrasound or endometrial biopsy.
5. Subject has a history of osteoporosis or other metabolic bone disease.
6. Subject has a current history of undiagnosed abnormal genital bleeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo BID for the 6-month Treatment Period
Elagolix 150 mg QD	elagolix	Elagolix 150 mg once daily (QD) for the 6-month Treatment Period
Elagolix 200 mg BID	elagolix	Elagolix 200 mg twice daily (BID) for the 6-month Treatment Period

Primary Outcome Measures

Name	Time	Method
Percentage of Responders at Month 3 Based on Daily Assessment of Non-Menstrual Pelvic Pain (NMPP)	At Month 3 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 3 Based on Daily Assessment of Dysmenorrhea (DYS)	At Month 3 of the Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Month 6 in NMPP	Baseline, Month 6 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 6 in DYS	Baseline, Month 6 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 3 in Numeric Rating Scale (NRS) Scores	Baseline, Month 3 of the Treatment Period	The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 3 in Analgesic Use Across Both Classes of Rescue Analgesics	Baseline, Month 3 of Treatment Period	Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Change From Baseline to Month 6 in Analgesic Use Across Both Classes of Rescue Analgesics	Baseline, Month 6 of Treatment Period	Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Change From Baseline to Month 3 in Dyspareunia (DYSP)	Baseline, Month 3 of Treatment Period	The DYSP pain scale ranges from 0 (absent) to 3 (severe).
Change From Baseline to Month 3 in Use of Narcotic Class of Medication (Opioids)	Baseline, Month 3 of Treatment Period	Permitted rescue narcotic analgesics included 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Percentage of Responders at Month 1 Based on Daily Assessment of DYS	At Month 1 of the Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 2 Based on Daily Assessment of DYS	At Month 2 of the Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 4 Based on Daily Assessment of DYS	At Month 4 of the Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 5 Based on Daily Assessment of DYS	At Month 5 of the Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 6 Based on Daily Assessment of DYS	At Month 6 of the Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 1 Based on Daily Assessment of NMPP	At Month 1 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 2 Based on Daily Assessment of NMPP	At Month 2 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 4 Based on Daily Assessment of NMPP	At Month 4 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 5 Based on Daily Assessment of NMPP	At Month 5 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 6 Based on Daily Assessment of NMPP	At Month 6 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 1 for DYSP	At Month 1 of the Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 2 for DYSP	At Month 2 of the Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Change From Baseline to Month 2 in Mean Pain Score for DYS	Baseline, Month 2 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 3 in Mean Pain Score for DYS	Baseline, Month 3 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 4 in Mean Pain Score for DYS	Baseline, Month 4 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 1 in Mean Pain Score for DYS	Baseline, Month 1 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Percentage of Responders at Month 4 for DYSP	At Month 4 of the Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percentage of Responders at Month 6 for DYSP	At Month 6 of the Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Change From Baseline to Month 1 in Mean Pain Score for DYS	Baseline, Month 1 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 5 in Mean Pain Score for DYS	Baseline, Month 5 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 3 in Mean Pain Score for DYS	Baseline, Month 3 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 1 in Mean Pain Score for NMPP	Baseline, Month 1 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 2 in Mean Pain Score for NMPP	Baseline, Month 2 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 3 in Mean Pain Score for NMPP	Baseline, Month 3 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percentage of Responders at Month 5 for DYSP	At Month 5 of the Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe). The criteria for a responder was based on a pre-defined threshold and accounted for analgesic use.
Percent Change From Baseline to Month 2 in Mean Pain Score for DYS	Baseline, Month 2 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 4 in Mean Pain Score for NMPP	Baseline, Month 4 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 5 in Mean Pain Score for NMPP	Baseline, Month 5 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 1 in Mean Pain Score for NMPP	Baseline, Month 1 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 2 in Mean Pain Score for NMPP	Baseline, Month 2 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 3 in Mean Pain Score for NMPP	Baseline, Month 3 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 4 in Mean Pain Score for NMPP	Baseline, Month 4 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 5 in Mean Pain Score for NMPP	Baseline, Month 5 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 2 in Mean Pain Score of DYSP	Baseline, Month 2 of Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 5 in Mean Pain Score of DYSP	Baseline, Month 5 of Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Response to Patient Global Impression of Change (PGIC) at Month 1	Month 1 of Treatment Period	The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Response to PGIC at Month 2	Month 2 of Treatment Period	The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Response to PGIC at Month 3	Month 3 of Treatment Period	The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Response to PGIC at Month 4	Month 4 of Treatment Period	The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Percent Change From Baseline to Month 4 in Mean Pain Score for DYS	Baseline, Month 4 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 5 in Mean Pain Score for DYS	Baseline, Month 5 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Percent Change From Baseline to Month 6 in Mean Pain Score for DYS	Baseline, Month 6 of Treatment Period	The DYS pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 1 in the Pain Domain of the Endometriosis Health Profile-30 (EHP-30)	Baseline, Month 1 of Treatment Period	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Percent Change From Baseline to Month 6 in Mean Pain Score for NMPP	Baseline, Month 6 of Treatment Period	The NMPP pain scale ranges from 0 (none) to 3 (severe).
Change From Baseline to Month 1 in Mean Pain Score of DYSP	Baseline, Month 1 of Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 4 in Mean Pain Score of DYSP	Baseline, Month 4 of Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 3 in the Pain Domain of the EHP-30	Baseline, Month 3 of Treatment Period	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Month 6 in the Pain Domain of the EHP-30	Baseline, Month 6 of Treatment Period	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Month 1 in the Sexual Intercourse Domain of the EHP-30	Baseline, Month 1 of Treatment Period	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Month 3 in the Sexual Intercourse Domain of the EHP-30	Baseline, Month 3 of Treatment Period	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domain is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Month 6 in the Sexual Intercourse Domain of the EHP-30	Baseline, Month 6 of Treatment Period	The EHP-30 is a disease-specific self-administered questionnaire used to measure health-related quality of life in women with endometriosis. Each domian is calculated on a scale from 0 = best possible health status to 100 = worst possible health status.
Change From Baseline to Month 1 in Health Related Productivity Questionnaire (HRPQ): Number of Hours of Work Lost From Workplace Due to Absenteeism	Baseline, Month 1 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	Baseline, Month 2 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	Baseline, Month 3 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 6 in Mean Pain Score of DYSP	Baseline, Month 6 of Treatment Period	The DYSP pain scale ranged from 0 (absent) to 3 (severe).
Change From Baseline to Month 1 in Analgesic Use Across Both Classes of Rescue Analgesics	Baseline, Month 1 of Treatment Period	Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Change From Baseline to Month 2 in Analgesic Use Across Both Classes of Rescue Analgesics	Baseline, Month 2 of Treatment Period	Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Change From Baseline to Month 4 in Analgesic Use Across Both Classes of Rescue Analgesics	Baseline, Month 4 of Treatment Period	Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Change From Baseline to Month 5 in Analgesic Use Across Both Classes of Rescue Analgesics	Baseline, Month 5 of Treatment Period	Permitted rescue medications included the nonsteroidal anti-inflammatory drug naproxen (500 mg), the narcotic analgesics 5 mg hydrocodone + 300 or 325 mg acetaminophen, and 30 mg codeine + 300 mg acetaminophen. Assessment was based on average pill counts.
Response to PGIC at Month 5	Month 5 of Treatment Period	The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Response to PGIC at Month 6	Month 6 of Treatment Period	The PGIC questionnaire is a self-reported 7-point scale rating a participant's overall impression of change from 1 = very much improved to 7 = very much worse. Participants evaluated the change in their endometriosis-associated pain since initiation of study drug.
Change From Baseline to Month 1 in NRS Scores	Baseline, Month 1 of Treatment Period	The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 2 in NRS Scores	Baseline, Month 2 of Treatment Period	The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 4 in NRS Scores	Baseline, Month 4 of Treatment Period	The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 5 in NRS Scores	Baseline, Month 5 of Treatment Period	The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 6 in NRS Scores	Baseline, Month 6 of Treatment Period	The NRS for overall endometriosis-associated pain ranges 0 (none) to 10 (worst pain ever).
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	Baseline, Month 4 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	Baseline, Month 5 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Absenteeism	Baseline, Month 6 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	Baseline, Month 1 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	Baseline, Month 2 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	Baseline, Month 3 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	Baseline, Month 2 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	Baseline, Month 4 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	Baseline, Month 5 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	Baseline, Month 4 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	Baseline, Month 5 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Absenteeism	Baseline, Month 6 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	Baseline, Month 1 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	Baseline, Month 3 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 4 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	Baseline, Month 4 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	Baseline, Month 6 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	Baseline, Month 4 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 3 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	Baseline, Month 3 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 6 in HRPQ: Number of Hours of Work Lost From Workplace Due to Presenteeism	Baseline, Month 6 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 1 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	Baseline, Month 1 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 2 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	Baseline, Month 2 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 5 in HRPQ: Number of Hours of Work Lost From Household Due to Presenteeism	Baseline, Month 5 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to presenteeism \[working while sick\]) in the 7 days prior to survey administration.
Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	Baseline, Month 1 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	Baseline, Month 2 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 1 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	Baseline, Month 1 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	Baseline, Month 3 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	Baseline, Month 5 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	Baseline, Month 6 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Number of Participants With Endometriosis-Related Non-Study Health Visits During the Treatment Period	Up to Month 6 of Treatment Period
Number of Days of Hospitalization	Up to Month 6 of Treatment Period
Number of Participants With Emergency Room/Outpatient Procedures During the Treatment Period, by Type	Up to Month 6 of Treatment Period
Change From Baseline to Month 3 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	Baseline, Month 3 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 2 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	Baseline, Month 2 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 4 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Household	Baseline, Month 4 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the household due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 5 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	Baseline, Month 5 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.
Change From Baseline to Month 6 in HRPQ: Total (Absenteeism and Presenteeism) Number of Hours of Work Lost From Workplace	Baseline, Month 6 of Treatment Period	The HRPQ consists of questions measuring the impact of endometriosis-associated pain and its treatment on work productivity (number of work hours lost from the workplace due to absenteeism and presenteeism) in the 7 days prior to survey administration.