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

Endometriosis Clinical Trial

Official title:

A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Estradiol/Norethindrone Acetate in Subjects With Moderate to Severe Endometriosis-Associated Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213457
• Other study ID #: M14-702
• Status: Completed
• Phase: Phase 3
• Start date: July 7, 2017
• Est. completion date: December 6, 2023

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate safety and efficacy of elagolix in the management of moderate to severe endometriosis-associated pain in adult premenopausal female participants including the safety and efficacy of elagolix in combination with concomitant hormonal add-back therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 681
• Est. completion date: December 6, 2023
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.
• Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization within 10 years prior to entry into Washout or Screening.
• Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
• Participant must have the following documented in the e-Diary during the last 35 days

prior to Study Day 1:

1. At least 2 days of "moderate" or "severe" dysmenorrhea (DYS) AND either

2. At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (NMPP) and an average NMPP score of at least 1.0, OR

3. At least 4 days of "moderate" or "severe" NMPP and an average NMPP score of at least 0.5.

Exclusion Criteria:

• Participant has chronic pelvic pain that is not caused by endometriosis, that requires chronic analgesic therapy, which would interfere with the assessment of endometriosis-related pain.
• Participant is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled or intranasal corticosteroids are allowed.
• Participant has a history of any major depression or post-traumatic stress disorder (PTSD) within 2 years of the screening visit or other major psychiatric disorder at any time.
• Participant has a history of suicide attempts or answered "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the last 1 year at Screening or prior to randomization on Day 1.
• Participant has any history of osteoporosis or other metabolic bone disease or any condition that would interfere with obtaining adequate dual energy x-ray absorptiometry (DXA) measurements
• Screening DXA results of the lumbar spine (L1-L4), femoral neck or total hip bone mineral density (BMD) corresponding to less than 2.0 or more standard deviations below normal.
• Participant has either:

1. a newly diagnosed, clinically significant medical condition that requires therapeutic intervention (e.g., new onset hypertension), that has not been stabilized 30 days prior to randomization on Day 1 OR

2. a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR

3. an unstable medical condition that makes the subject an unsuitable candidate for the study in the opinion of the Investigator, (including, but not limited to, uncontrolled diabetes mellitus, uncontrolled hypertension, epilepsy requiring anti-epileptic medication, unstable angina, confirmed inflammatory bowel disease, hyperprolactinemia, clinically significant infection or injury).

• Participant has any conditions contraindicated with use of E2/NETA.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Estradiol/Norethindrone Acetate
Tablets
• Placebo for Elagolix
Tablet
• Elagolix
Tablet
• Placebo for E2/NETA
Tablets

Locations

Country	Name	City	State
Canada	The Ottawa Hospital /ID# 148927	Ottawa	Ontario
Canada	Strand Clinic /ID# 152582	St. John's	Newfoundland and Labrador
Canada	Medicor Research Inc /ID# 151453	Sudbury	Ontario
Canada	Mount Sinai Hosp.-Toronto /ID# 148972	Toronto	Ontario
Canada	Victory Reproductive Care /ID# 149016	Windsor	Ontario
Puerto Rico	Puerto Rico Medical Research /ID# 152040	Ponce
Puerto Rico	Clinical Research Puerto Rico /ID# 149018	San Juan
Puerto Rico	Rodriguez-Ginorio, San Juan /ID# 145545	San Juan
Puerto Rico	School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546	San Juan
United States	Albuquerque Clinical Trials, Inc /ID# 154747	Albuquerque	New Mexico
United States	Bosque Women's Care /ID# 147084	Albuquerque	New Mexico
United States	Paramount Research Solutions /ID# 145226	Alpharetta	Georgia
United States	Paramount Research Solutions /ID# 149320	Alpharetta	Georgia
United States	ClinSite, LLC /ID# 145314	Ann Arbor	Michigan
United States	Agile Clinical Research Trials /ID# 145494	Atlanta	Georgia
United States	Atlanta Women's Research Inst /ID# 145543	Atlanta	Georgia
United States	AA (Austin Area) ObGyn PLLC /ID# 205696	Austin	Texas
United States	Lotus Gynecology /ID# 148479	Austin	Texas
United States	Sirius Clinical Research, LLC /ID# 154749	Austin	Texas
United States	American Health Network of Ind /ID# 167996	Avon	Indiana
United States	Baltimore Suburban Health /ID# 147164	Baltimore	Maryland
United States	Univ Maryland School Medicine /ID# 151739	Baltimore	Maryland
United States	Eastern Maine Medical Center /ID# 161681	Bangor	Maine
United States	Great Lakes Research Group, Inc. /ID# 145308	Bay City	Michigan
United States	Gadolin Research, LLC /ID# 201383	Beaumont	Texas
United States	Clinical Inquest Center Ltd /ID# 147107	Beavercreek	Ohio
United States	Center for Assisted Reprod. /ID# 154748	Bedford	Texas
United States	Alabama Clinical Therapeutics, LLC /ID# 145503	Birmingham	Alabama
United States	Alabama Clinical Therapeutics, LLC /ID# 151468	Birmingham	Alabama
United States	Central Research Associates /ID# 163087	Birmingham	Alabama
United States	Helix Biomedics, LLC /ID# 147108	Boynton Beach	Florida
United States	Gulf Coast Research Group /ID# 162895	Brandon	Florida
United States	Holston Medical Group /ID# 145449	Bristol	Tennessee
United States	SUNY Downstate Medical Center /ID# 148749	Brooklyn	New York
United States	Main Line Fertility Center /ID# 150099	Bryn Mawr	Pennsylvania
United States	Core Healthcare Group /ID# 149321	Cerritos	California
United States	Women's Health Practice, LLC /ID# 145517	Champaign	Illinois
United States	DJL Clinical Research, PLLC /ID# 154679	Charlotte	North Carolina
United States	PMG Research of Charlotte /ID# 145432	Charlotte	North Carolina
United States	Chattanooga Medical Research /ID# 145184	Chattanooga	Tennessee
United States	WR-ClinSearch /ID# 145205	Chattanooga	Tennessee
United States	CTI Clinical Research Center /ID# 145428	Cincinnati	Ohio
United States	The Christ Hospital /ID# 149244	Cincinnati	Ohio
United States	University of Cincinnati /ID# 145496	Cincinnati	Ohio
United States	Olympian Clinical Research /ID# 148167	Clearwater	Florida
United States	Univ Hosp Cleveland /ID# 148741	Cleveland	Ohio
United States	Apogee Women's Health Inc. /ID# 145149	College Park	Georgia
United States	Vista Clinical Research /ID# 148767	Columbia	South Carolina
United States	Aventiv Research, Inc. /ID# 145492	Columbus	Ohio
United States	Aventiv Research, Inc. /ID# 162896	Columbus	Ohio
United States	Columbus Regional Research Ins /ID# 159752	Columbus	Georgia
United States	The Ohio State University /ID# 145444	Columbus	Ohio
United States	Clinical Trials Management, LLC - Covington /ID# 145220	Covington	Louisiana
United States	Clinical Trials Management, LLC - Covington /ID# 145520	Covington	Louisiana
United States	Texas Health Presbyterian Hosp /ID# 150098	Dallas	Texas
United States	UT Southwestern Medical Center /ID# 145201	Dallas	Texas
United States	Omega Research Maitland, LLC /ID# 145167	DeBary	Florida
United States	Downtown Womens Health Care /ID# 147955	Denver	Colorado
United States	Corner Canyon Obstetrics and G /ID# 145519	Draper	Utah
United States	Carolina Women's Research and Wellness Center /ID# 145356	Durham	North Carolina
United States	HRC Fertility /ID# 154143	Encino	California
United States	OB/GYN Associates of Erie /ID# 157935	Erie	Pennsylvania
United States	Horizon Research Group /ID# 148171	Eunice	Louisiana
United States	Wright State University & CTRA /ID# 145512	Fairborn	Ohio
United States	Southern Women's Specialists PC /ID# 148750	Fairhope	Alabama
United States	Genesis Clinical Research - Fall River /ID# 148573	Fall River	Massachusetts
United States	NECCR Fall River LLC /ID# 145329	Fall River	Massachusetts
United States	KO Clinical Research, LLC /ID# 145410	Fort Lauderdale	Florida
United States	Clinical Physiology Associates /ID# 145237	Fort Myers	Florida
United States	Women's Health Advantage /ID# 145495	Fort Wayne	Indiana
United States	Baylor Scott & White /ID# 170430	Fort Worth	Texas
United States	Signature Gyn Services /ID# 145534	Fort Worth	Texas
United States	Southampton Women's Health /ID# 151691	Franklin	Virginia
United States	Willowbend Health and Wellness - Frisco /ID# 145245	Frisco	Texas
United States	Glendale Adventist Medical Ctr /ID# 160530	Glendale	California
United States	Unified Women's Clinical Research-Greensboro /ID# 155543	Greensboro	North Carolina
United States	University Medical Group /ID# 148777	Greenville	South Carolina
United States	Advanced Women's Health Institute /ID# 145396	Greenwood Village	Colorado
United States	Penn State University and Milton S. Hershey Medical Center /ID# 145231	Hershey	Pennsylvania
United States	Pinewest Ob-Gyn, Inc. /ID# 151743	High Point	North Carolina
United States	Advances in Health, Inc. /ID# 145425	Houston	Texas
United States	Centex Studies, Inc /ID# 148776	Houston	Texas
United States	Houston Methodist Hospital /ID# 170586	Houston	Texas
United States	Next Innovative Clinical Research /ID# 203863	Houston	Texas
United States	Precision Research Institute - Houston /ID# 154370	Houston	Texas
United States	The Woman's Hospital of Texas /ID# 145316	Houston	Texas
United States	HCP Clinical Research LLC /ID# 152045	Huntington Beach	California
United States	Clinical Research Prime /ID# 161724	Idaho Falls	Idaho
United States	Womens Healthcare Assoc, DBA /ID# 148744	Idaho Falls	Idaho
United States	Alliance Research Centers /ID# 151240	Irvine	California
United States	The Jackson Clinic, PA /ID# 145303	Jackson	Tennessee
United States	Solutions Through Adv Rch /ID# 148768	Jacksonville	Florida
United States	Vida Clinical Research /ID# 150282	Kissimmee	Florida
United States	Red Rocks OB/GYN /ID# 145325	Lakewood	Colorado
United States	FMC Science /ID# 150981	Lampasas	Texas
United States	Accent Clinical Trials /ID# 147109	Las Vegas	Nevada
United States	Office of Edmond E. Pack, MD /ID# 148747	Las Vegas	Nevada
United States	R. Garn Mabey Jr, MD Chartered /ID# 145361	Las Vegas	Nevada
United States	Scott Research Inc. /ID# 161704	Laurelton	New York
United States	Tanner Clinic /ID# 148786	Layton	Utah
United States	Womens Clinic of Lincoln, P.C. /ID# 145366	Lincoln	Nebraska
United States	Long Beach Clinical Trial Serv /ID# 152428	Long Beach	California
United States	Olympia Clinical Trials /ID# 202325	Los Angeles	California
United States	Bluegrass Clinical Research /ID# 151209	Louisville	Kentucky
United States	University of Louisville /ID# 154751	Louisville	Kentucky
United States	Axcess Medical Center /ID# 148169	Loxahatchee Groves	Florida
United States	Praetorian Pharmaceutical Res /ID# 145405	Marrero	Louisiana
United States	Research Memphis Associates, LLC /ID# 150100	Memphis	Tennessee
United States	Advanced Clinical Research /ID# 147086	Meridian	Idaho
United States	Sonora Clinical Research /ID# 145541	Meridian	Idaho
United States	Mesa Obstetricians and Gynecologists /ID# 147320	Mesa	Arizona
United States	Genoma Research Group, Inc /ID# 152558	Miami	Florida
United States	Palmetto Professional Research /ID# 153838	Miami	Florida
United States	Vista Health Research LLC - Miami /ID# 151455	Miami	Florida
United States	Precision Research Organization /ID# 145337	Miami Lakes	Florida
United States	Ocean Blue Medical Research Center, Inc /ID# 145514	Miami Springs	Florida
United States	Trinity Health Center Town /ID# 147102	Minot	North Dakota
United States	Salom Tangir, LLC /ID# 148739	Miramar	Florida
United States	Mobile, Ob-Gyn, P.C. /ID# 145364	Mobile	Alabama
United States	University of South Alabama /ID# 148774	Mobile	Alabama
United States	Women's Health Alliance of Mobile /ID# 150083	Mobile	Alabama
United States	Venus Gynecology, LLC /ID# 145336	Myrtle Beach	South Carolina
United States	Asr, Llc /Id# 161680	Nampa	Idaho
United States	Access Clinical Trials, Inc. /ID# 145224	Nashville	Tennessee
United States	Jersey Shore University Medical Center /ID# 148756	Neptune	New Jersey
United States	Eastern Carolina Women's Centr /ID# 145386	New Bern	North Carolina
United States	Rutgers Robert Wood Johnson /ID# 152858	New Brunswick	New Jersey
United States	Ochsner Baptist OB/GYN Clinic /ID# 147144	New Orleans	Louisiana
United States	Women Under Study, LLC /ID# 151216	New Orleans	Louisiana
United States	Suncoast Clinical Research /ID# 145484	New Port Richey	Florida
United States	Columbia Univ Medical Center /ID# 145334	New York	New York
United States	Manhattan Medical Research /ID# 145175	New York	New York
United States	Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477	Newport News	Virginia
United States	James T. Martin, Jr., MD., Obs /ID# 148755	North Charleston	South Carolina
United States	Clinical Research Partners, LL /ID# 145392	North Chesterfield	Virginia
United States	Clinical Research Partners, LL /ID# 145416	North Chesterfield	Virginia
United States	California Medical Research As /ID# 154746	Northridge	California
United States	Futura Research, Org /ID# 145406	Norwalk	California
United States	Affinity Clinical Research /ID# 151469	Oak Brook	Illinois
United States	Hamburg Regional Gynecology Gr /ID# 161705	Orchard Park	New York
United States	Center for Women's Research, Inc /ID# 145486	Palos Heights	Illinois
United States	The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459	Park Ridge	Illinois
United States	Huntington Medical Foundation /ID# 154750	Pasadena	California
United States	Drexel Univ College of Med /ID# 149789	Philadelphia	Pennsylvania
United States	University of Pennsylvania /ID# 145470	Philadelphia	Pennsylvania
United States	Revere Health /ID# 145540	Pleasant Grove	Utah
United States	Oregon Health and Science University /ID# 155705	Portland	Oregon
United States	Clinical Research Adv, Inc. /ID# 149257	Puyallup	Washington
United States	Unified Women's Clinical Resea /ID# 145353	Raleigh	North Carolina
United States	Alliance Womens Health /ID# 148770	Richmond	Virginia
United States	Clinical Trials Virginia, Inc. /ID# 145430	Richmond	Virginia
United States	Northern California Research /ID# 159753	Sacramento	California
United States	Saginaw Valley Med Res Group /ID# 145527	Saginaw	Michigan
United States	Oncova Clinical Research, Inc. /ID# 148175	Saint Cloud	Florida
United States	Prism Research /ID# 159751	Saint Paul	Minnesota
United States	Meridien Research - St Petersburg /ID# 145345	Saint Petersburg	Florida
United States	Clinical Trials of Texas, Inc /ID# 147100	San Antonio	Texas
United States	Discovery Clinical Trials-San Antonio /ID# 145363	San Antonio	Texas
United States	VIP Trials /ID# 151745	San Antonio	Texas
United States	MD Strategies Research Centers /ID# 152429	San Diego	California
United States	Precision Research Institute - San Diego /ID# 152557	San Diego	California
United States	Physician Care Clin. Res., LLC /ID# 145511	Sarasota	Florida
United States	Meridian Clinical Research, LLC /ID# 148176	Savannah	Georgia
United States	Unity Health- Searcy Medical Center /ID# 203674	Searcy	Arkansas
United States	Seattle Women's Health, Research, Gynecology /ID# 145341	Seattle	Washington
United States	Virginia Mason Medical Center /ID# 145387	Seattle	Washington
United States	Womens & Family Care, LLC dba /ID# 145211	Shawnee Mission	Kansas
United States	Omni Fertility and Laser Insti /ID# 145532	Shreveport	Louisiana
United States	Women's Health Clinic /ID# 155707	Shreveport	Louisiana
United States	Alta California Medical Group /ID# 155706	Simi Valley	California
United States	Frontier Clinical Research /ID# 162091	Smithfield	Pennsylvania
United States	Wayne State University Physician Group - Southfield /ID# 145431	Southfield	Michigan
United States	North Spokane Women's Health /ID# 145382	Spokane	Washington
United States	Treasure Coast Research /ID# 148174	Stuart	Florida
United States	Houston Ctr for Clin Research /ID# 148799	Sugar Land	Texas
United States	Palmetto Clinical Research /ID# 150992	Summerville	South Carolina
United States	Atlanta Gynecology Research Institute /ID# 149322	Suwanee	Georgia
United States	Madigan Army Medical Center /ID# 145186	Tacoma	Washington
United States	Stedman Clinical Trials /ID# 152554	Tampa	Florida
United States	University of South Florida /ID# 145424	Tampa	Florida
United States	The Women's Health Group - Thornton /ID# 203707	Thornton	Colorado
United States	University of Toledo /ID# 145403	Toledo	Ohio
United States	St. Joseph's Regional Medical /ID# 157759	Totowa	New Jersey
United States	Continental Clinical Solutions /ID# 152041	Towson	Maryland
United States	Arizona Research Assoc /ID# 161703	Tucson	Arizona
United States	Eclipse Clinical Research /ID# 155600	Tucson	Arizona
United States	Tidewater Clinical Research /ID# 145397	Virginia Beach	Virginia
United States	James A. Simon, MD, PC /ID# 145480	Washington	District of Columbia
United States	Brown Clinic, PLLP /ID# 154372	Watertown	South Dakota
United States	Center of Reproductive Medicin /ID# 145467	Webster	Texas
United States	Virtus Research Consultants, LLC /ID# 147101	Wellington	Florida
United States	The Iowa Clinic /ID# 145409	West Des Moines	Iowa
United States	Comprehensive Clinical Trials /ID# 145148	West Palm Beach	Florida
United States	OB.GYN Associates of WNY /ID# 161665	West Seneca	New York
United States	Cypress Medical Research Ctr /ID# 147159	Wichita	Kansas
United States	PRN Professional Research Network of Kansas, LLC /ID# 151463	Wichita	Kansas
United States	PMG Research of Wilmington /ID# 152555	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment	Participants recorded rescue analgesic use for endometriosis-associated pain daily and DYS (pain during menstruation ) and its impact on daily activities each day of their period in an electronic diary (e-Diary). DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary 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.; Pain scores and analgesic use were averaged over 35 days prior to each visit.; Response was defined as a reduction of -0.92 or more from baseline in DYS 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).	Month 6, Month 12
Primary	Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary 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.; Pain scores and analgesic use were averaged over the 35 days prior to each visit.; Response was defined as a reduction of -0.55 or greater from baseline for NMPP 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).	Month 6, Month 12
Secondary	Change From Baseline in DYS at Month 12 Based on Daily Assessment	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary 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.; Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 12
Secondary	Change From Baseline in DYS at Month 6 Based on Daily Assessment	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort; Mild discomfort but I was easily able to do the things I usually do; Moderate discomfort or pain that made it difficult to do some of the things I usually do; 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.	Baseline, Month 6
Secondary	Change From Baseline in DYS at Month 3 Based on Daily Assessment	Participants assessed DYS (pain during menstruation) and its impact on their daily activities each day of their period in an e-Diary. DYS was measured by the 4-point Endometriosis Daily Pain Impact Diary according to the following: 0: No discomfort; Mild discomfort but I was easily able to do the things I usually do; Moderate discomfort or pain that made it difficult to do some of the things I usually do; 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.	Baseline, Month 3
Secondary	Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary 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.; Pain scores and analgesic use were averaged over the 35 days prior to each visit.	Baseline, Month 12
Secondary	Change From Baseline in NMPP at Month 6 Based on Daily Assessment	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary 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.; Pain scores and analgesic use were averaged over the 35 days prior to each visit.	Baseline, Month 6
Secondary	Change From Baseline in NMPP at Month 3 Based on Daily Assessment	Participants recorded rescue analgesic medication for endometriosis-associated pain and assessed NMPP and its impact on their daily activities each day in an e-Diary was measured by the 4-point Endometriosis Daily Pain Impact Diary 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.; Pain scores and analgesic use were averaged over the 35 days prior to each visit.	Baseline, Month 3
Secondary	Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score	The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.	Baseline, Month 6
Secondary	Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment	Participants assessed DYSP 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.	Baseline, Month 12
Secondary	Change From Baseline in DYSP at Month 6 Based on Daily Assessment	Participants assessed DYSP 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.	Baseline, Month 6
Secondary	Change From Baseline in DYSP at Month 3 Based on Daily Assessment	Participants assessed DYSP 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.	Baseline, Month 3
Secondary	Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score	The PROMIS Fatigue Short Form 6a is self-administered and composed of 6 questions to evaluate fatigue over the past 7 days. All questions employ the following five response options: 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, and 5 = Always. The PROMIS Fatigue 6a score is calculated as a T-score, which is a standardized score with a mean of 50 (based on the average for the United States general population) and a standard deviation (SD) of 10. Higher scores indicate higher levels of fatigue. A decrease in score (negative change from baseline) indicates improvement in fatigue.	Baseline, Month 12
Secondary	Change From Baseline in Endometriosis-Associated Pain Score at Month 12 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. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 12
Secondary	Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With 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. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 6
Secondary	Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With 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. Site staff administered the Overall Endometriosis-Associated Pain questionnaire assessing pain over a 7-day recall period, and recorded the participant's response electronically via a tablet at the time of visit. Pain scores were averaged over the 35 days prior to each visit.	Baseline, Month 3

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