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

Primary Purpose

Endometriosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Estradiol/Norethindrone Acetate
Placebo for Elagolix
Elagolix
Placebo for E2/NETA
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis focused on measuring Elagolix, Endometriosis associated pain, Dysmenorrhea (DYS), Non-menstrual pelvic pain (NMPP), ORILISSA

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Central Research Associates /ID# 163087
  • Alabama Clinical Therapeutics, LLC /ID# 145503
  • Alabama Clinical Therapeutics, LLC /ID# 151468
  • Southern Women's Specialists PC /ID# 148750
  • Women's Health Alliance of Mobile /ID# 150083
  • University of South Alabama /ID# 148774
  • Mobile, Ob-Gyn, P.C. /ID# 145364
  • Mesa Obstetricians and Gynecologists /ID# 147320
  • Arizona Research Assoc /ID# 161703
  • Eclipse Clinical Research /ID# 155600
  • Unity Health- Searcy Medical Center /ID# 203674
  • Core Healthcare Group /ID# 149321
  • HRC Fertility /ID# 154143
  • Glendale Adventist Medical Ctr /ID# 160530
  • HCP Clinical Research LLC /ID# 152045
  • Alliance Research Centers /ID# 151240
  • Long Beach Clinical Trial Serv /ID# 152428
  • Olympia Clinical Trials /ID# 202325
  • California Medical Research As /ID# 154746
  • Futura Research, Org /ID# 145406
  • Huntington Medical Foundation /ID# 154750
  • Northern California Research /ID# 159753
  • Precision Research Institute - San Diego /ID# 152557
  • MD Strategies Research Centers /ID# 152429
  • Alta California Medical Group /ID# 155706
  • Downtown Womens Health Care /ID# 147955
  • Advanced Women's Health Institute /ID# 145396
  • Red Rocks OB/GYN /ID# 145325
  • The Women's Health Group - Thornton /ID# 203707
  • James A. Simon, MD, PC /ID# 145480
  • Helix Biomedics, LLC /ID# 147108
  • Gulf Coast Research Group /ID# 162895
  • Olympian Clinical Research /ID# 148167
  • Omega Research Maitland, LLC /ID# 145167
  • KO Clinical Research, LLC /ID# 145410
  • Clinical Physiology Associates /ID# 145237
  • Solutions Through Adv Rch /ID# 148768
  • Vida Clinical Research /ID# 150282
  • Axcess Medical Center /ID# 148169
  • Precision Research Organization /ID# 145337
  • Ocean Blue Medical Research Center, Inc /ID# 145514
  • Genoma Research Group, Inc /ID# 152558
  • Vista Health Research LLC - Miami /ID# 151455
  • Palmetto Professional Research /ID# 153838
  • Salom Tangir, LLC /ID# 148739
  • Suncoast Clinical Research /ID# 145484
  • Oncova Clinical Research, Inc. /ID# 148175
  • Meridien Research - St Petersburg /ID# 145345
  • Physician Care Clin. Res., LLC /ID# 145511
  • Treasure Coast Research /ID# 148174
  • University of South Florida /ID# 145424
  • Stedman Clinical Trials /ID# 152554
  • Virtus Research Consultants, LLC /ID# 147101
  • Comprehensive Clinical Trials /ID# 145148
  • Paramount Research Solutions /ID# 145226
  • Paramount Research Solutions /ID# 149320
  • Agile Clinical Research Trials /ID# 145494
  • Atlanta Women's Research Inst /ID# 145543
  • Apogee Women's Health Inc. /ID# 145149
  • Columbus Regional Research Ins /ID# 159752
  • Meridian Clinical Research, LLC /ID# 148176
  • Atlanta Gynecology Research Institute /ID# 149322
  • Clinical Research Prime /ID# 161724
  • Womens Healthcare Assoc, DBA /ID# 148744
  • Advanced Clinical Research /ID# 147086
  • Sonora Clinical Research /ID# 145541
  • Asr, Llc /Id# 161680
  • Women's Health Practice, LLC /ID# 145517
  • Affinity Clinical Research /ID# 151469
  • Center for Women's Research, Inc /ID# 145486
  • The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459
  • American Health Network of Ind /ID# 167996
  • Women's Health Advantage /ID# 145495
  • The Iowa Clinic /ID# 145409
  • Womens & Family Care, LLC dba /ID# 145211
  • PRN Professional Research Network of Kansas, LLC /ID# 151463
  • Cypress Medical Research Ctr /ID# 147159
  • University of Louisville /ID# 154751
  • Bluegrass Clinical Research /ID# 151209
  • Clinical Trials Management, LLC - Covington /ID# 145220
  • Clinical Trials Management, LLC - Covington /ID# 145520
  • Horizon Research Group /ID# 148171
  • Praetorian Pharmaceutical Res /ID# 145405
  • Ochsner Baptist OB/GYN Clinic /ID# 147144
  • Women Under Study, LLC /ID# 151216
  • Women's Health Clinic /ID# 155707
  • Omni Fertility and Laser Insti /ID# 145532
  • Eastern Maine Medical Center /ID# 161681
  • Univ Maryland School Medicine /ID# 151739
  • Baltimore Suburban Health /ID# 147164
  • Continental Clinical Solutions /ID# 152041
  • NECCR Fall River LLC /ID# 145329
  • Genesis Clinical Research - Fall River /ID# 148573
  • ClinSite, LLC /ID# 145314
  • Great Lakes Research Group, Inc. /ID# 145308
  • Saginaw Valley Med Res Group /ID# 145527
  • Wayne State University Physician Group - Southfield /ID# 145431
  • Prism Research /ID# 159751
  • Womens Clinic of Lincoln, P.C. /ID# 145366
  • Accent Clinical Trials /ID# 147109
  • Office of Edmond E. Pack, MD /ID# 148747
  • R. Garn Mabey Jr, MD Chartered /ID# 145361
  • Jersey Shore University Medical Center /ID# 148756
  • Rutgers Robert Wood Johnson /ID# 152858
  • St. Joseph's Regional Medical /ID# 157759
  • Albuquerque Clinical Trials, Inc /ID# 154747
  • Bosque Women's Care /ID# 147084
  • SUNY Downstate Medical Center /ID# 148749
  • Scott Research Inc. /ID# 161704
  • Manhattan Medical Research /ID# 145175
  • Columbia Univ Medical Center /ID# 145334
  • Hamburg Regional Gynecology Gr /ID# 161705
  • OB.GYN Associates of WNY /ID# 161665
  • PMG Research of Charlotte /ID# 145432
  • DJL Clinical Research, PLLC /ID# 154679
  • Carolina Women's Research and Wellness Center /ID# 145356
  • Unified Women's Clinical Research-Greensboro /ID# 155543
  • Pinewest Ob-Gyn, Inc. /ID# 151743
  • Eastern Carolina Women's Centr /ID# 145386
  • Unified Women's Clinical Resea /ID# 145353
  • PMG Research of Wilmington /ID# 152555
  • Trinity Health Center Town /ID# 147102
  • Clinical Inquest Center Ltd /ID# 147107
  • CTI Clinical Research Center /ID# 145428
  • The Christ Hospital /ID# 149244
  • University of Cincinnati /ID# 145496
  • Univ Hosp Cleveland /ID# 148741
  • The Ohio State University /ID# 145444
  • Aventiv Research, Inc. /ID# 145492
  • Aventiv Research, Inc. /ID# 162896
  • Wright State University & CTRA /ID# 145512
  • University of Toledo /ID# 145403
  • Oregon Health and Science University /ID# 155705
  • Main Line Fertility Center /ID# 150099
  • OB/GYN Associates of Erie /ID# 157935
  • Penn State University and Milton S. Hershey Medical Center /ID# 145231
  • University of Pennsylvania /ID# 145470
  • Drexel Univ College of Med /ID# 149789
  • Frontier Clinical Research /ID# 162091
  • Vista Clinical Research /ID# 148767
  • University Medical Group /ID# 148777
  • Venus Gynecology, LLC /ID# 145336
  • James T. Martin, Jr., MD., Obs /ID# 148755
  • Palmetto Clinical Research /ID# 150992
  • Brown Clinic, PLLP /ID# 154372
  • Holston Medical Group /ID# 145449
  • Chattanooga Medical Research /ID# 145184
  • WR-ClinSearch /ID# 145205
  • The Jackson Clinic, PA /ID# 145303
  • Research Memphis Associates, LLC /ID# 150100
  • Access Clinical Trials, Inc. /ID# 145224
  • Lotus Gynecology /ID# 148479
  • AA (Austin Area) ObGyn PLLC /ID# 205696
  • Sirius Clinical Research, LLC /ID# 154749
  • Gadolin Research, LLC /ID# 201383
  • Center for Assisted Reprod. /ID# 154748
  • Texas Health Presbyterian Hosp /ID# 150098
  • UT Southwestern Medical Center /ID# 145201
  • Baylor Scott & White /ID# 170430
  • Signature Gyn Services /ID# 145534
  • Willowbend Health and Wellness - Frisco /ID# 145245
  • Next Innovative Clinical Research /ID# 203863
  • Advances in Health, Inc. /ID# 145425
  • Houston Methodist Hospital /ID# 170586
  • Precision Research Institute - Houston /ID# 154370
  • The Woman's Hospital of Texas /ID# 145316
  • Centex Studies, Inc /ID# 148776
  • FMC Science /ID# 150981
  • Clinical Trials of Texas, Inc /ID# 147100
  • VIP Trials /ID# 151745
  • Discovery Clinical Trials-San Antonio /ID# 145363
  • Houston Ctr for Clin Research /ID# 148799
  • Center of Reproductive Medicin /ID# 145467
  • Corner Canyon Obstetrics and G /ID# 145519
  • Tanner Clinic /ID# 148786
  • Revere Health /ID# 145540
  • Southampton Women's Health /ID# 151691
  • Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477
  • Clinical Research Partners, LL /ID# 145392
  • Clinical Research Partners, LL /ID# 145416
  • Clinical Trials Virginia, Inc. /ID# 145430
  • Alliance Womens Health /ID# 148770
  • Tidewater Clinical Research /ID# 145397
  • Clinical Research Adv, Inc. /ID# 149257
  • Virginia Mason Medical Center /ID# 145387
  • Seattle Women's Health, Research, Gynecology /ID# 145341
  • North Spokane Women's Health /ID# 145382
  • Madigan Army Medical Center /ID# 145186
  • Strand Clinic /ID# 152582
  • The Ottawa Hospital /ID# 148927
  • Medicor Research Inc /ID# 151453
  • Mount Sinai Hosp.-Toronto /ID# 148972
  • Victory Reproductive Care /ID# 149016
  • Puerto Rico Medical Research /ID# 152040
  • Clinical Research Puerto Rico /ID# 149018
  • Rodriguez-Ginorio, San Juan /ID# 145545
  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Elagolix / Elagolix + E2/NETA

Elagolix + E2/NETA

Arm Description

Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.

Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.

Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 7, 2017
Last Updated
February 14, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03213457
Brief Title
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 7, 2017 (Actual)
Primary Completion Date
March 27, 2020 (Actual)
Study Completion Date
January 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
Elagolix, Endometriosis associated pain, Dysmenorrhea (DYS), Non-menstrual pelvic pain (NMPP), ORILISSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
681 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for elagolix administered twice daily (BID) plus placebo for estradiol/norethindrone acetate (E2/NETA) administered once daily (QD) for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Arm Title
Elagolix / Elagolix + E2/NETA
Arm Type
Experimental
Arm Description
Elagolix 200 mg BID alone for the first 6 months of the 12-month placebo-controlled Treatment Period and elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the second 6 months, followed by elagolix 200 mg BID+E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Arm Title
Elagolix + E2/NETA
Arm Type
Experimental
Arm Description
Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period, followed by elagolix 200 mg BID plus E2/NETA 1 mg/0.5 mg QD for the remaining 36 months of the Treatment Period.
Intervention Type
Drug
Intervention Name(s)
Estradiol/Norethindrone Acetate
Other Intervention Name(s)
Activella, E2/NETA
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo for Elagolix
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Elagolix
Other Intervention Name(s)
ABT-620, Elagolix Sodium, ORILISSA
Intervention Description
Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo for E2/NETA
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment
Description
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).
Time Frame
Month 6, Month 12
Title
Co-Primary Endpoint: Percentage of Participants With a Response for Non-menstrual Pelvic Pain (NMPP) at Months 6 and 12 Based on Daily Assessment
Description
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).
Time Frame
Month 6, Month 12
Secondary Outcome Measure Information:
Title
Change From Baseline in DYS at Month 12 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 12
Title
Change From Baseline in DYS at Month 6 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in DYS at Month 3 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 3
Title
Change From Baseline in Non-menstrual Pelvic Pain (NMPP) at Month 12 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 12
Title
Change From Baseline in NMPP at Month 6 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in NMPP at Month 3 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 3
Title
Change From Baseline to Month 6 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Dyspareunia (DYSP) at Month 12 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 12
Title
Change From Baseline in DYSP at Month 6 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in DYSP at Month 3 Based on Daily Assessment
Description
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.
Time Frame
Baseline, Month 3
Title
Change From Baseline to Month 12 in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 6a T-Score
Description
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.
Time Frame
Baseline, Month 12
Title
Change From Baseline in Endometriosis-Associated Pain Score at Month 12 Assessed With Numeric Rating Scale (NRS)
Description
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.
Time Frame
Baseline, Month 12
Title
Change From Baseline in Endometriosis-Associated Pain Score at Month 6 Assessed With NRS
Description
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.
Time Frame
Baseline, Month 6
Title
Change From Baseline in Endometriosis-Associated Pain Score at Month 3 Assessed With NRS
Description
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.
Time Frame
Baseline, Month 3

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: At least 2 days of "moderate" or "severe" dysmenorrhea (DYS) AND either At least 2 days of "moderate" or "severe" non-menstrual pelvic pain (NMPP) and an average NMPP score of at least 1.0, OR 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: 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 a clinically significant medical condition that is anticipated to require intervention during the course of study participation (e.g., anticipated major elective surgery) OR 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates /ID# 163087
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Alabama Clinical Therapeutics, LLC /ID# 145503
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Alabama Clinical Therapeutics, LLC /ID# 151468
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235-3430
Country
United States
Facility Name
Southern Women's Specialists PC /ID# 148750
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532-3029
Country
United States
Facility Name
Women's Health Alliance of Mobile /ID# 150083
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-1410
Country
United States
Facility Name
University of South Alabama /ID# 148774
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604-3302
Country
United States
Facility Name
Mobile, Ob-Gyn, P.C. /ID# 145364
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Mesa Obstetricians and Gynecologists /ID# 147320
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85209
Country
United States
Facility Name
Arizona Research Assoc /ID# 161703
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Eclipse Clinical Research /ID# 155600
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Unity Health- Searcy Medical Center /ID# 203674
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143-4802
Country
United States
Facility Name
Core Healthcare Group /ID# 149321
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
HRC Fertility /ID# 154143
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Glendale Adventist Medical Ctr /ID# 160530
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
HCP Clinical Research LLC /ID# 152045
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Alliance Research Centers /ID# 151240
City
Irvine
State/Province
California
ZIP/Postal Code
92612-1245
Country
United States
Facility Name
Long Beach Clinical Trial Serv /ID# 152428
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Olympia Clinical Trials /ID# 202325
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036-4667
Country
United States
Facility Name
California Medical Research As /ID# 154746
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Futura Research, Org /ID# 145406
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Huntington Medical Foundation /ID# 154750
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Northern California Research /ID# 159753
City
Sacramento
State/Province
California
ZIP/Postal Code
95821-2640
Country
United States
Facility Name
Precision Research Institute - San Diego /ID# 152557
City
San Diego
State/Province
California
ZIP/Postal Code
92114-3643
Country
United States
Facility Name
MD Strategies Research Centers /ID# 152429
City
San Diego
State/Province
California
ZIP/Postal Code
92119
Country
United States
Facility Name
Alta California Medical Group /ID# 155706
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Downtown Womens Health Care /ID# 147955
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Advanced Women's Health Institute /ID# 145396
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Red Rocks OB/GYN /ID# 145325
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228-1810
Country
United States
Facility Name
The Women's Health Group - Thornton /ID# 203707
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229-4385
Country
United States
Facility Name
James A. Simon, MD, PC /ID# 145480
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Helix Biomedics, LLC /ID# 147108
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436-6634
Country
United States
Facility Name
Gulf Coast Research Group /ID# 162895
City
Brandon
State/Province
Florida
ZIP/Postal Code
33510
Country
United States
Facility Name
Olympian Clinical Research /ID# 148167
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 145167
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
KO Clinical Research, LLC /ID# 145410
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Clinical Physiology Associates /ID# 145237
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Solutions Through Adv Rch /ID# 148768
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Vida Clinical Research /ID# 150282
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741-2345
Country
United States
Facility Name
Axcess Medical Center /ID# 148169
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Precision Research Organization /ID# 145337
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016-1501
Country
United States
Facility Name
Ocean Blue Medical Research Center, Inc /ID# 145514
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Genoma Research Group, Inc /ID# 152558
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Vista Health Research LLC - Miami /ID# 151455
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-1032
Country
United States
Facility Name
Palmetto Professional Research /ID# 153838
City
Miami
State/Province
Florida
ZIP/Postal Code
33186-1309
Country
United States
Facility Name
Salom Tangir, LLC /ID# 148739
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Suncoast Clinical Research /ID# 145484
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Oncova Clinical Research, Inc. /ID# 148175
City
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
Facility Name
Meridien Research - St Petersburg /ID# 145345
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709-3113
Country
United States
Facility Name
Physician Care Clin. Res., LLC /ID# 145511
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Treasure Coast Research /ID# 148174
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
University of South Florida /ID# 145424
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Stedman Clinical Trials /ID# 152554
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Virtus Research Consultants, LLC /ID# 147101
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Comprehensive Clinical Trials /ID# 145148
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Paramount Research Solutions /ID# 145226
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Paramount Research Solutions /ID# 149320
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30005
Country
United States
Facility Name
Agile Clinical Research Trials /ID# 145494
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328-5532
Country
United States
Facility Name
Atlanta Women's Research Inst /ID# 145543
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Apogee Women's Health Inc. /ID# 145149
City
College Park
State/Province
Georgia
ZIP/Postal Code
30349
Country
United States
Facility Name
Columbus Regional Research Ins /ID# 159752
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Meridian Clinical Research, LLC /ID# 148176
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406-2675
Country
United States
Facility Name
Atlanta Gynecology Research Institute /ID# 149322
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024-7159
Country
United States
Facility Name
Clinical Research Prime /ID# 161724
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Womens Healthcare Assoc, DBA /ID# 148744
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Advanced Clinical Research /ID# 147086
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Sonora Clinical Research /ID# 145541
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646-1144
Country
United States
Facility Name
Asr, Llc /Id# 161680
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83687
Country
United States
Facility Name
Women's Health Practice, LLC /ID# 145517
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Affinity Clinical Research /ID# 151469
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Center for Women's Research, Inc /ID# 145486
City
Palos Heights
State/Province
Illinois
ZIP/Postal Code
60463-1440
Country
United States
Facility Name
The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
American Health Network of Ind /ID# 167996
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123-7960
Country
United States
Facility Name
Women's Health Advantage /ID# 145495
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
The Iowa Clinic /ID# 145409
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Womens & Family Care, LLC dba /ID# 145211
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66218
Country
United States
Facility Name
PRN Professional Research Network of Kansas, LLC /ID# 151463
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Cypress Medical Research Ctr /ID# 147159
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
University of Louisville /ID# 154751
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Bluegrass Clinical Research /ID# 151209
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291-1988
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 145220
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Clinical Trials Management, LLC - Covington /ID# 145520
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
Horizon Research Group /ID# 148171
City
Eunice
State/Province
Louisiana
ZIP/Postal Code
70535
Country
United States
Facility Name
Praetorian Pharmaceutical Res /ID# 145405
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Ochsner Baptist OB/GYN Clinic /ID# 147144
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Women Under Study, LLC /ID# 151216
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70125-1923
Country
United States
Facility Name
Women's Health Clinic /ID# 155707
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118-3133
Country
United States
Facility Name
Omni Fertility and Laser Insti /ID# 145532
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71118
Country
United States
Facility Name
Eastern Maine Medical Center /ID# 161681
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Univ Maryland School Medicine /ID# 151739
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Baltimore Suburban Health /ID# 147164
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Continental Clinical Solutions /ID# 152041
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
NECCR Fall River LLC /ID# 145329
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720-2972
Country
United States
Facility Name
Genesis Clinical Research - Fall River /ID# 148573
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02723
Country
United States
Facility Name
ClinSite, LLC /ID# 145314
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Great Lakes Research Group, Inc. /ID# 145308
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
Facility Name
Saginaw Valley Med Res Group /ID# 145527
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Wayne State University Physician Group - Southfield /ID# 145431
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Prism Research /ID# 159751
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Womens Clinic of Lincoln, P.C. /ID# 145366
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Accent Clinical Trials /ID# 147109
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106-4017
Country
United States
Facility Name
Office of Edmond E. Pack, MD /ID# 148747
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
R. Garn Mabey Jr, MD Chartered /ID# 145361
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Jersey Shore University Medical Center /ID# 148756
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753-4859
Country
United States
Facility Name
Rutgers Robert Wood Johnson /ID# 152858
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
St. Joseph's Regional Medical /ID# 157759
City
Totowa
State/Province
New Jersey
ZIP/Postal Code
07512
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc /ID# 154747
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Bosque Women's Care /ID# 147084
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
SUNY Downstate Medical Center /ID# 148749
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Scott Research Inc. /ID# 161704
City
Laurelton
State/Province
New York
ZIP/Postal Code
11413
Country
United States
Facility Name
Manhattan Medical Research /ID# 145175
City
New York
State/Province
New York
ZIP/Postal Code
10016-6023
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 145334
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Hamburg Regional Gynecology Gr /ID# 161705
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
OB.GYN Associates of WNY /ID# 161665
City
West Seneca
State/Province
New York
ZIP/Postal Code
14224
Country
United States
Facility Name
PMG Research of Charlotte /ID# 145432
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
DJL Clinical Research, PLLC /ID# 154679
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8508
Country
United States
Facility Name
Carolina Women's Research and Wellness Center /ID# 145356
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
Facility Name
Unified Women's Clinical Research-Greensboro /ID# 155543
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Pinewest Ob-Gyn, Inc. /ID# 151743
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Eastern Carolina Women's Centr /ID# 145386
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Unified Women's Clinical Resea /ID# 145353
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
PMG Research of Wilmington /ID# 152555
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401-6638
Country
United States
Facility Name
Trinity Health Center Town /ID# 147102
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Clinical Inquest Center Ltd /ID# 147107
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431-2573
Country
United States
Facility Name
CTI Clinical Research Center /ID# 145428
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
The Christ Hospital /ID# 149244
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati /ID# 145496
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Univ Hosp Cleveland /ID# 148741
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University /ID# 145444
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1257
Country
United States
Facility Name
Aventiv Research, Inc. /ID# 145492
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Aventiv Research, Inc. /ID# 162896
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Wright State University & CTRA /ID# 145512
City
Fairborn
State/Province
Ohio
ZIP/Postal Code
45324
Country
United States
Facility Name
University of Toledo /ID# 145403
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oregon Health and Science University /ID# 155705
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Main Line Fertility Center /ID# 150099
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
OB/GYN Associates of Erie /ID# 157935
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507-1423
Country
United States
Facility Name
Penn State University and Milton S. Hershey Medical Center /ID# 145231
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania /ID# 145470
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Facility Name
Drexel Univ College of Med /ID# 149789
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
Frontier Clinical Research /ID# 162091
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Vista Clinical Research /ID# 148767
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
University Medical Group /ID# 148777
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Venus Gynecology, LLC /ID# 145336
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
James T. Martin, Jr., MD., Obs /ID# 148755
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Palmetto Clinical Research /ID# 150992
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485-7539
Country
United States
Facility Name
Brown Clinic, PLLP /ID# 154372
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Holston Medical Group /ID# 145449
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620-7346
Country
United States
Facility Name
Chattanooga Medical Research /ID# 145184
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
WR-ClinSearch /ID# 145205
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1605
Country
United States
Facility Name
The Jackson Clinic, PA /ID# 145303
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Research Memphis Associates, LLC /ID# 150100
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-3895
Country
United States
Facility Name
Access Clinical Trials, Inc. /ID# 145224
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Lotus Gynecology /ID# 148479
City
Austin
State/Province
Texas
ZIP/Postal Code
78703-1448
Country
United States
Facility Name
AA (Austin Area) ObGyn PLLC /ID# 205696
City
Austin
State/Province
Texas
ZIP/Postal Code
78758-5653
Country
United States
Facility Name
Sirius Clinical Research, LLC /ID# 154749
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Gadolin Research, LLC /ID# 201383
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702-1100
Country
United States
Facility Name
Center for Assisted Reprod. /ID# 154748
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
Texas Health Presbyterian Hosp /ID# 150098
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
UT Southwestern Medical Center /ID# 145201
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-7208
Country
United States
Facility Name
Baylor Scott & White /ID# 170430
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-4110
Country
United States
Facility Name
Signature Gyn Services /ID# 145534
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Willowbend Health and Wellness - Frisco /ID# 145245
City
Frisco
State/Province
Texas
ZIP/Postal Code
75035
Country
United States
Facility Name
Next Innovative Clinical Research /ID# 203863
City
Houston
State/Province
Texas
ZIP/Postal Code
77004-6031
Country
United States
Facility Name
Advances in Health, Inc. /ID# 145425
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital /ID# 170586
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Precision Research Institute - Houston /ID# 154370
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
The Woman's Hospital of Texas /ID# 145316
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Centex Studies, Inc /ID# 148776
City
Houston
State/Province
Texas
ZIP/Postal Code
77058-2705
Country
United States
Facility Name
FMC Science /ID# 150981
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Clinical Trials of Texas, Inc /ID# 147100
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
VIP Trials /ID# 151745
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
Discovery Clinical Trials-San Antonio /ID# 145363
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Houston Ctr for Clin Research /ID# 148799
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Center of Reproductive Medicin /ID# 145467
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Corner Canyon Obstetrics and G /ID# 145519
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Tanner Clinic /ID# 148786
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Revere Health /ID# 145540
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Southampton Women's Health /ID# 151691
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Facility Name
Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Clinical Research Partners, LL /ID# 145392
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235-4722
Country
United States
Facility Name
Clinical Research Partners, LL /ID# 145416
City
North Chesterfield
State/Province
Virginia
ZIP/Postal Code
23235-4722
Country
United States
Facility Name
Clinical Trials Virginia, Inc. /ID# 145430
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Alliance Womens Health /ID# 148770
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226-1930
Country
United States
Facility Name
Tidewater Clinical Research /ID# 145397
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Clinical Research Adv, Inc. /ID# 149257
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Virginia Mason Medical Center /ID# 145387
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Women's Health, Research, Gynecology /ID# 145341
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
North Spokane Women's Health /ID# 145382
City
Spokane
State/Province
Washington
ZIP/Postal Code
99207
Country
United States
Facility Name
Madigan Army Medical Center /ID# 145186
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
Strand Clinic /ID# 152582
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 4Y3
Country
Canada
Facility Name
The Ottawa Hospital /ID# 148927
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Medicor Research Inc /ID# 151453
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5M4
Country
Canada
Facility Name
Mount Sinai Hosp.-Toronto /ID# 148972
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Victory Reproductive Care /ID# 149016
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 5R7
Country
Canada
Facility Name
Puerto Rico Medical Research /ID# 152040
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico /ID# 149018
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Rodriguez-Ginorio, San Juan /ID# 145545
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
34435897
Citation
Watts NB, Binkley N, Owens CD, Al-Hendy A, Puscheck EE, Shebley M, Schlaff WD, Simon JA. Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life. J Womens Health (Larchmt). 2021 Oct;30(10):1416-1430. doi: 10.1089/jwh.2020.8989. Epub 2021 Aug 25.
Results Reference
derived
Links:
URL
https://www.rxabbvie.com/
Description
Related info

Learn more about this trial

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

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