A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain
Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03213457
Collaborator
(none)
681
197
3
66.8
3.5
0.1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
681 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jul 7, 2017
Actual Primary Completion Date
:
Mar 27, 2020
Anticipated Study Completion Date
:
Jan 30, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo 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. |
Drug: Placebo for Elagolix
Tablet
Drug: Placebo for E2/NETA
Tablets
|
| Experimental: Elagolix / Elagolix + E2/NETA 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. |
Drug: Estradiol/Norethindrone Acetate
Tablets
Other Names:
Drug: Elagolix
Tablet
Other Names:
|
| Experimental: Elagolix + E2/NETA 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. |
Drug: Estradiol/Norethindrone Acetate
Tablets
Other Names:
Drug: Elagolix
Tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Co-Primary Endpoint: Percentage of Participants With a Response for Dysmenorrhea (DYS) at Months 6 and 12 Based on Daily Assessment [Month 6, Month 12]
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 [Month 6, Month 12]
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 [Baseline, Month 12]
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 [Baseline, Month 6]
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 [Baseline, Month 3]
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 [Baseline, Month 12]
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 [Baseline, Month 6]
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 [Baseline, Month 3]
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 [Baseline, Month 6]
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 [Baseline, Month 12]
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 [Baseline, Month 6]
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 [Baseline, Month 3]
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 [Baseline, Month 12]
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) [Baseline, Month 12]
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 [Baseline, Month 6]
The NRS measured endometriosis-associated pain with and without menstruation on an 11-point scale from 0 = no pain to 10 = worst pain ever. 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 [Baseline, Month 3]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participant is a premenopausal female 18 to 49 years of age (inclusive) at the time of Screening.
-
Participant has a documented surgical diagnosis (e.g., laparoscopy or laparotomy) of endometriosis established by visualization 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Central Research Associates /ID# 163087 | Birmingham | Alabama | United States | 35205 |
| 2 | Alabama Clinical Therapeutics, LLC /ID# 145503 | Birmingham | Alabama | United States | 35235-3430 |
| 3 | Alabama Clinical Therapeutics, LLC /ID# 151468 | Birmingham | Alabama | United States | 35235-3430 |
| 4 | Southern Women's Specialists PC /ID# 148750 | Fairhope | Alabama | United States | 36532-3029 |
| 5 | Women's Health Alliance of Mobile /ID# 150083 | Mobile | Alabama | United States | 36604-1410 |
| 6 | University of South Alabama /ID# 148774 | Mobile | Alabama | United States | 36604-3302 |
| 7 | Mobile, Ob-Gyn, P.C. /ID# 145364 | Mobile | Alabama | United States | 36608 |
| 8 | Mesa Obstetricians and Gynecologists /ID# 147320 | Mesa | Arizona | United States | 85209 |
| 9 | Arizona Research Assoc /ID# 161703 | Tucson | Arizona | United States | 85712 |
| 10 | Eclipse Clinical Research /ID# 155600 | Tucson | Arizona | United States | 85745 |
| 11 | Unity Health- Searcy Medical Center /ID# 203674 | Searcy | Arkansas | United States | 72143-4802 |
| 12 | Core Healthcare Group /ID# 149321 | Cerritos | California | United States | 90703 |
| 13 | HRC Fertility /ID# 154143 | Encino | California | United States | 91436 |
| 14 | Glendale Adventist Medical Ctr /ID# 160530 | Glendale | California | United States | 91206 |
| 15 | HCP Clinical Research LLC /ID# 152045 | Huntington Beach | California | United States | 92646 |
| 16 | Alliance Research Centers /ID# 151240 | Irvine | California | United States | 92612-1245 |
| 17 | Long Beach Clinical Trial Serv /ID# 152428 | Long Beach | California | United States | 90806 |
| 18 | Olympia Clinical Trials /ID# 202325 | Los Angeles | California | United States | 90036-4667 |
| 19 | California Medical Research As /ID# 154746 | Northridge | California | United States | 91324 |
| 20 | Futura Research, Org /ID# 145406 | Norwalk | California | United States | 90650 |
| 21 | Huntington Medical Foundation /ID# 154750 | Pasadena | California | United States | 91105 |
| 22 | Northern California Research /ID# 159753 | Sacramento | California | United States | 95821-2640 |
| 23 | Precision Research Institute - San Diego /ID# 152557 | San Diego | California | United States | 92114-3643 |
| 24 | MD Strategies Research Centers /ID# 152429 | San Diego | California | United States | 92119 |
| 25 | Alta California Medical Group /ID# 155706 | Simi Valley | California | United States | 93065 |
| 26 | Downtown Womens Health Care /ID# 147955 | Denver | Colorado | United States | 80209 |
| 27 | Advanced Women's Health Institute /ID# 145396 | Greenwood Village | Colorado | United States | 80111 |
| 28 | Red Rocks OB/GYN /ID# 145325 | Lakewood | Colorado | United States | 80228-1810 |
| 29 | The Women's Health Group - Thornton /ID# 203707 | Thornton | Colorado | United States | 80229-4385 |
| 30 | James A. Simon, MD, PC /ID# 145480 | Washington | District of Columbia | United States | 20036 |
| 31 | Helix Biomedics, LLC /ID# 147108 | Boynton Beach | Florida | United States | 33436-6634 |
| 32 | Gulf Coast Research Group /ID# 162895 | Brandon | Florida | United States | 33510 |
| 33 | Olympian Clinical Research /ID# 148167 | Clearwater | Florida | United States | 33756 |
| 34 | Omega Research Maitland, LLC /ID# 145167 | DeBary | Florida | United States | 32713-2260 |
| 35 | KO Clinical Research, LLC /ID# 145410 | Fort Lauderdale | Florida | United States | 33316 |
| 36 | Clinical Physiology Associates /ID# 145237 | Fort Myers | Florida | United States | 33912 |
| 37 | Solutions Through Adv Rch /ID# 148768 | Jacksonville | Florida | United States | 32256 |
| 38 | Vida Clinical Research /ID# 150282 | Kissimmee | Florida | United States | 34741-2345 |
| 39 | Axcess Medical Center /ID# 148169 | Loxahatchee Groves | Florida | United States | 33470 |
| 40 | Precision Research Organization /ID# 145337 | Miami Lakes | Florida | United States | 33016-1501 |
| 41 | Ocean Blue Medical Research Center, Inc /ID# 145514 | Miami Springs | Florida | United States | 33166 |
| 42 | Genoma Research Group, Inc /ID# 152558 | Miami | Florida | United States | 33165 |
| 43 | Vista Health Research LLC - Miami /ID# 151455 | Miami | Florida | United States | 33176-1032 |
| 44 | Palmetto Professional Research /ID# 153838 | Miami | Florida | United States | 33186-1309 |
| 45 | Salom Tangir, LLC /ID# 148739 | Miramar | Florida | United States | 33027 |
| 46 | Suncoast Clinical Research /ID# 145484 | New Port Richey | Florida | United States | 34652 |
| 47 | Oncova Clinical Research, Inc. /ID# 148175 | Saint Cloud | Florida | United States | 34769 |
| 48 | Meridien Research - St Petersburg /ID# 145345 | Saint Petersburg | Florida | United States | 33709-3113 |
| 49 | Physician Care Clin. Res., LLC /ID# 145511 | Sarasota | Florida | United States | 34239 |
| 50 | Treasure Coast Research /ID# 148174 | Stuart | Florida | United States | 34996 |
| 51 | University of South Florida /ID# 145424 | Tampa | Florida | United States | 33612 |
| 52 | Stedman Clinical Trials /ID# 152554 | Tampa | Florida | United States | 33613 |
| 53 | Virtus Research Consultants, LLC /ID# 147101 | Wellington | Florida | United States | 33414 |
| 54 | Comprehensive Clinical Trials /ID# 145148 | West Palm Beach | Florida | United States | 33409 |
| 55 | Paramount Research Solutions /ID# 145226 | Alpharetta | Georgia | United States | 30005 |
| 56 | Paramount Research Solutions /ID# 149320 | Alpharetta | Georgia | United States | 30005 |
| 57 | Agile Clinical Research Trials /ID# 145494 | Atlanta | Georgia | United States | 30328-5532 |
| 58 | Atlanta Women's Research Inst /ID# 145543 | Atlanta | Georgia | United States | 30342 |
| 59 | Apogee Women's Health Inc. /ID# 145149 | College Park | Georgia | United States | 30349 |
| 60 | Columbus Regional Research Ins /ID# 159752 | Columbus | Georgia | United States | 31904 |
| 61 | Meridian Clinical Research, LLC /ID# 148176 | Savannah | Georgia | United States | 31406-2675 |
| 62 | Atlanta Gynecology Research Institute /ID# 149322 | Suwanee | Georgia | United States | 30024-7159 |
| 63 | Clinical Research Prime /ID# 161724 | Idaho Falls | Idaho | United States | 83404 |
| 64 | Womens Healthcare Assoc, DBA /ID# 148744 | Idaho Falls | Idaho | United States | 83404 |
| 65 | Advanced Clinical Research /ID# 147086 | Meridian | Idaho | United States | 83642 |
| 66 | Sonora Clinical Research /ID# 145541 | Meridian | Idaho | United States | 83646-1144 |
| 67 | Asr, Llc /Id# 161680 | Nampa | Idaho | United States | 83687 |
| 68 | Women's Health Practice, LLC /ID# 145517 | Champaign | Illinois | United States | 61820 |
| 69 | Affinity Clinical Research /ID# 151469 | Oak Brook | Illinois | United States | 60523 |
| 70 | Center for Women's Research, Inc /ID# 145486 | Palos Heights | Illinois | United States | 60463-1440 |
| 71 | The Advanced Gynecologic Surgery Institute - Park Ridge /ID# 151459 | Park Ridge | Illinois | United States | 60068 |
| 72 | American Health Network of Ind /ID# 167996 | Avon | Indiana | United States | 46123-7960 |
| 73 | Women's Health Advantage /ID# 145495 | Fort Wayne | Indiana | United States | 46825 |
| 74 | The Iowa Clinic /ID# 145409 | West Des Moines | Iowa | United States | 50266 |
| 75 | Womens & Family Care, LLC dba /ID# 145211 | Shawnee Mission | Kansas | United States | 66218 |
| 76 | PRN Professional Research Network of Kansas, LLC /ID# 151463 | Wichita | Kansas | United States | 67205 |
| 77 | Cypress Medical Research Ctr /ID# 147159 | Wichita | Kansas | United States | 67226 |
| 78 | University of Louisville /ID# 154751 | Louisville | Kentucky | United States | 40202 |
| 79 | Bluegrass Clinical Research /ID# 151209 | Louisville | Kentucky | United States | 40291-1988 |
| 80 | Clinical Trials Management, LLC - Covington /ID# 145220 | Covington | Louisiana | United States | 70433 |
| 81 | Clinical Trials Management, LLC - Covington /ID# 145520 | Covington | Louisiana | United States | 70433 |
| 82 | Horizon Research Group /ID# 148171 | Eunice | Louisiana | United States | 70535 |
| 83 | Praetorian Pharmaceutical Res /ID# 145405 | Marrero | Louisiana | United States | 70072 |
| 84 | Ochsner Baptist OB/GYN Clinic /ID# 147144 | New Orleans | Louisiana | United States | 70115 |
| 85 | Women Under Study, LLC /ID# 151216 | New Orleans | Louisiana | United States | 70125-1923 |
| 86 | Women's Health Clinic /ID# 155707 | Shreveport | Louisiana | United States | 71118-3133 |
| 87 | Omni Fertility and Laser Insti /ID# 145532 | Shreveport | Louisiana | United States | 71118 |
| 88 | Eastern Maine Medical Center /ID# 161681 | Bangor | Maine | United States | 04401 |
| 89 | Univ Maryland School Medicine /ID# 151739 | Baltimore | Maryland | United States | 21201 |
| 90 | Baltimore Suburban Health /ID# 147164 | Baltimore | Maryland | United States | 21208 |
| 91 | Continental Clinical Solutions /ID# 152041 | Towson | Maryland | United States | 21204 |
| 92 | NECCR Fall River LLC /ID# 145329 | Fall River | Massachusetts | United States | 02720-2972 |
| 93 | Genesis Clinical Research - Fall River /ID# 148573 | Fall River | Massachusetts | United States | 02723 |
| 94 | ClinSite, LLC /ID# 145314 | Ann Arbor | Michigan | United States | 48105 |
| 95 | Great Lakes Research Group, Inc. /ID# 145308 | Bay City | Michigan | United States | 48602 |
| 96 | Saginaw Valley Med Res Group /ID# 145527 | Saginaw | Michigan | United States | 48604 |
| 97 | Wayne State University Physician Group - Southfield /ID# 145431 | Southfield | Michigan | United States | 48034 |
| 98 | Prism Research /ID# 159751 | Saint Paul | Minnesota | United States | 55114 |
| 99 | Womens Clinic of Lincoln, P.C. /ID# 145366 | Lincoln | Nebraska | United States | 68510 |
| 100 | Accent Clinical Trials /ID# 147109 | Las Vegas | Nevada | United States | 89106-4017 |
| 101 | Office of Edmond E. Pack, MD /ID# 148747 | Las Vegas | Nevada | United States | 89113 |
| 102 | R. Garn Mabey Jr, MD Chartered /ID# 145361 | Las Vegas | Nevada | United States | 89128 |
| 103 | Jersey Shore University Medical Center /ID# 148756 | Neptune | New Jersey | United States | 07753-4859 |
| 104 | Rutgers Robert Wood Johnson /ID# 152858 | New Brunswick | New Jersey | United States | 08901 |
| 105 | St. Joseph's Regional Medical /ID# 157759 | Totowa | New Jersey | United States | 07512 |
| 106 | Albuquerque Clinical Trials, Inc /ID# 154747 | Albuquerque | New Mexico | United States | 87102 |
| 107 | Bosque Women's Care /ID# 147084 | Albuquerque | New Mexico | United States | 87109 |
| 108 | SUNY Downstate Medical Center /ID# 148749 | Brooklyn | New York | United States | 11203 |
| 109 | Scott Research Inc. /ID# 161704 | Laurelton | New York | United States | 11413 |
| 110 | Manhattan Medical Research /ID# 145175 | New York | New York | United States | 10016-6023 |
| 111 | Columbia Univ Medical Center /ID# 145334 | New York | New York | United States | 10032-3725 |
| 112 | Hamburg Regional Gynecology Gr /ID# 161705 | Orchard Park | New York | United States | 14127 |
| 113 | OB.GYN Associates of WNY /ID# 161665 | West Seneca | New York | United States | 14224 |
| 114 | PMG Research of Charlotte /ID# 145432 | Charlotte | North Carolina | United States | 28209 |
| 115 | DJL Clinical Research, PLLC /ID# 154679 | Charlotte | North Carolina | United States | 28210-8508 |
| 116 | Carolina Women's Research and Wellness Center /ID# 145356 | Durham | North Carolina | United States | 27713 |
| 117 | Unified Women's Clinical Research-Greensboro /ID# 155543 | Greensboro | North Carolina | United States | 27408 |
| 118 | Pinewest Ob-Gyn, Inc. /ID# 151743 | High Point | North Carolina | United States | 27262 |
| 119 | Eastern Carolina Women's Centr /ID# 145386 | New Bern | North Carolina | United States | 28562 |
| 120 | Unified Women's Clinical Resea /ID# 145353 | Raleigh | North Carolina | United States | 27607 |
| 121 | PMG Research of Wilmington /ID# 152555 | Wilmington | North Carolina | United States | 28401-6638 |
| 122 | Trinity Health Center Town /ID# 147102 | Minot | North Dakota | United States | 58701 |
| 123 | Clinical Inquest Center Ltd /ID# 147107 | Beavercreek | Ohio | United States | 45431-2573 |
| 124 | CTI Clinical Research Center /ID# 145428 | Cincinnati | Ohio | United States | 45212 |
| 125 | The Christ Hospital /ID# 149244 | Cincinnati | Ohio | United States | 45219 |
| 126 | University of Cincinnati /ID# 145496 | Cincinnati | Ohio | United States | 45267-0585 |
| 127 | Univ Hosp Cleveland /ID# 148741 | Cleveland | Ohio | United States | 44106 |
| 128 | The Ohio State University /ID# 145444 | Columbus | Ohio | United States | 43210-1257 |
| 129 | Aventiv Research, Inc. /ID# 145492 | Columbus | Ohio | United States | 43213 |
| 130 | Aventiv Research, Inc. /ID# 162896 | Columbus | Ohio | United States | 43213 |
| 131 | Wright State University & CTRA /ID# 145512 | Fairborn | Ohio | United States | 45324 |
| 132 | University of Toledo /ID# 145403 | Toledo | Ohio | United States | 43614 |
| 133 | Oregon Health and Science University /ID# 155705 | Portland | Oregon | United States | 97239 |
| 134 | Main Line Fertility Center /ID# 150099 | Bryn Mawr | Pennsylvania | United States | 19010 |
| 135 | OB/GYN Associates of Erie /ID# 157935 | Erie | Pennsylvania | United States | 16507-1423 |
| 136 | Penn State University and Milton S. Hershey Medical Center /ID# 145231 | Hershey | Pennsylvania | United States | 17033 |
| 137 | University of Pennsylvania /ID# 145470 | Philadelphia | Pennsylvania | United States | 19104-5502 |
| 138 | Drexel Univ College of Med /ID# 149789 | Philadelphia | Pennsylvania | United States | 19129 |
| 139 | Frontier Clinical Research /ID# 162091 | Smithfield | Pennsylvania | United States | 15478 |
| 140 | Vista Clinical Research /ID# 148767 | Columbia | South Carolina | United States | 29201 |
| 141 | University Medical Group /ID# 148777 | Greenville | South Carolina | United States | 29605 |
| 142 | Venus Gynecology, LLC /ID# 145336 | Myrtle Beach | South Carolina | United States | 29572 |
| 143 | James T. Martin, Jr., MD., Obs /ID# 148755 | North Charleston | South Carolina | United States | 29406 |
| 144 | Palmetto Clinical Research /ID# 150992 | Summerville | South Carolina | United States | 29485-7539 |
| 145 | Brown Clinic, PLLP /ID# 154372 | Watertown | South Dakota | United States | 57201 |
| 146 | Holston Medical Group /ID# 145449 | Bristol | Tennessee | United States | 37620-7346 |
| 147 | Chattanooga Medical Research /ID# 145184 | Chattanooga | Tennessee | United States | 37404 |
| 148 | WR-ClinSearch /ID# 145205 | Chattanooga | Tennessee | United States | 37421-1605 |
| 149 | The Jackson Clinic, PA /ID# 145303 | Jackson | Tennessee | United States | 38305 |
| 150 | Research Memphis Associates, LLC /ID# 150100 | Memphis | Tennessee | United States | 38119-3895 |
| 151 | Access Clinical Trials, Inc. /ID# 145224 | Nashville | Tennessee | United States | 37203 |
| 152 | Lotus Gynecology /ID# 148479 | Austin | Texas | United States | 78703-1448 |
| 153 | AA (Austin Area) ObGyn PLLC /ID# 205696 | Austin | Texas | United States | 78758-5653 |
| 154 | Sirius Clinical Research, LLC /ID# 154749 | Austin | Texas | United States | 78759 |
| 155 | Gadolin Research, LLC /ID# 201383 | Beaumont | Texas | United States | 77702-1100 |
| 156 | Center for Assisted Reprod. /ID# 154748 | Bedford | Texas | United States | 76022 |
| 157 | Texas Health Presbyterian Hosp /ID# 150098 | Dallas | Texas | United States | 75231 |
| 158 | UT Southwestern Medical Center /ID# 145201 | Dallas | Texas | United States | 75390-7208 |
| 159 | Baylor Scott & White /ID# 170430 | Fort Worth | Texas | United States | 76104-4110 |
| 160 | Signature Gyn Services /ID# 145534 | Fort Worth | Texas | United States | 76104 |
| 161 | Willowbend Health and Wellness - Frisco /ID# 145245 | Frisco | Texas | United States | 75035 |
| 162 | Next Innovative Clinical Research /ID# 203863 | Houston | Texas | United States | 77004-6031 |
| 163 | Advances in Health, Inc. /ID# 145425 | Houston | Texas | United States | 77030 |
| 164 | Houston Methodist Hospital /ID# 170586 | Houston | Texas | United States | 77030 |
| 165 | Precision Research Institute - Houston /ID# 154370 | Houston | Texas | United States | 77036 |
| 166 | The Woman's Hospital of Texas /ID# 145316 | Houston | Texas | United States | 77054 |
| 167 | Centex Studies, Inc /ID# 148776 | Houston | Texas | United States | 77058-2705 |
| 168 | FMC Science /ID# 150981 | Lampasas | Texas | United States | 76550 |
| 169 | Clinical Trials of Texas, Inc /ID# 147100 | San Antonio | Texas | United States | 78229 |
| 170 | VIP Trials /ID# 151745 | San Antonio | Texas | United States | 78230 |
| 171 | Discovery Clinical Trials-San Antonio /ID# 145363 | San Antonio | Texas | United States | 78258 |
| 172 | Houston Ctr for Clin Research /ID# 148799 | Sugar Land | Texas | United States | 77479 |
| 173 | Center of Reproductive Medicin /ID# 145467 | Webster | Texas | United States | 77598 |
| 174 | Corner Canyon Obstetrics and G /ID# 145519 | Draper | Utah | United States | 84020 |
| 175 | Tanner Clinic /ID# 148786 | Layton | Utah | United States | 84041 |
| 176 | Revere Health /ID# 145540 | Pleasant Grove | Utah | United States | 84062 |
| 177 | Southampton Women's Health /ID# 151691 | Franklin | Virginia | United States | 23851 |
| 178 | Health Research of Hampton Roads, Inc. (HRHR) /ID# 156477 | Newport News | Virginia | United States | 23606 |
| 179 | Clinical Research Partners, LL /ID# 145392 | North Chesterfield | Virginia | United States | 23235-4722 |
| 180 | Clinical Research Partners, LL /ID# 145416 | North Chesterfield | Virginia | United States | 23235-4722 |
| 181 | Clinical Trials Virginia, Inc. /ID# 145430 | Richmond | Virginia | United States | 23225 |
| 182 | Alliance Womens Health /ID# 148770 | Richmond | Virginia | United States | 23226-1930 |
| 183 | Tidewater Clinical Research /ID# 145397 | Virginia Beach | Virginia | United States | 23456 |
| 184 | Clinical Research Adv, Inc. /ID# 149257 | Puyallup | Washington | United States | 98372 |
| 185 | Virginia Mason Medical Center /ID# 145387 | Seattle | Washington | United States | 98101 |
| 186 | Seattle Women's Health, Research, Gynecology /ID# 145341 | Seattle | Washington | United States | 98105 |
| 187 | North Spokane Women's Health /ID# 145382 | Spokane | Washington | United States | 99207 |
| 188 | Madigan Army Medical Center /ID# 145186 | Tacoma | Washington | United States | 98431 |
| 189 | Strand Clinic /ID# 152582 | St. John's | Newfoundland and Labrador | Canada | A1A 4Y3 |
| 190 | The Ottawa Hospital /ID# 148927 | Ottawa | Ontario | Canada | K1H 8L6 |
| 191 | Medicor Research Inc /ID# 151453 | Sudbury | Ontario | Canada | P3E 5M4 |
| 192 | Mount Sinai Hosp.-Toronto /ID# 148972 | Toronto | Ontario | Canada | M5G 1X5 |
| 193 | Victory Reproductive Care /ID# 149016 | Windsor | Ontario | Canada | N8W 5R7 |
| 194 | Puerto Rico Medical Research /ID# 152040 | Ponce | Puerto Rico | 00717 | |
| 195 | Clinical Research Puerto Rico /ID# 149018 | San Juan | Puerto Rico | 00909 | |
| 196 | Rodriguez-Ginorio, San Juan /ID# 145545 | San Juan | Puerto Rico | 00917 | |
| 197 | School of Medicine University of Puerto Rico-Medical Science Campus /ID# 145546 | San Juan | Puerto Rico | 00935 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03213457
Other Study ID Numbers:
- M14-702
First Posted:
Jul 11, 2017
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by AbbVie
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 681 participants were randomized at 138 sites in 2 countries (United States [including Puerto Rico] and Canada). |
|---|---|
| Pre-assignment Detail | Participants were randomly assigned on Study Day 1 in a 4:1:2 ratio as follows: elagolix 200 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) 1 mg/0.5 mg once daily (QD) elagolix 200 mg BID placebo Data are presented for the 12-month placebo-controlled Treatment Period (data cutoff date of 12-May-2020). |
| Arm/Group Title | Placebo | Elagolix / Elagolix + E2/NETA | Elagolix + E2/NETA |
|---|---|---|---|
| Arm/Group Description | Placebo 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. |
| Period Title: Overall Study | |||
| STARTED | 194 | 98 | 389 |
| Randomized and Treated | 193 | 97 | 389 |
| COMPLETED | 106 | 59 | 215 |
| NOT COMPLETED | 88 | 39 | 174 |
Baseline Characteristics
| Arm/Group Title | Placebo | Elagolix / Elagolix + E2/NETA | Elagolix + E2/NETA | Total |
|---|---|---|---|---|
| Arm/Group Description | Placebo 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. | Total of all reporting groups |
| Overall Participants | 193 | 97 | 389 | 679 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
33.1
(6.72)
|
32.5
(6.44)
|
32.3
(6.74)
|
32.5
(6.69)
|
| Sex/Gender, Customized (Count of Participants) | ||||
| Female |
193
100%
|
97
100%
|
389
100%
|
679
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
37
19.2%
|
11
11.3%
|
58
14.9%
|
106
15.6%
|
| Not Hispanic or Latino |
156
80.8%
|
86
88.7%
|
331
85.1%
|
573
84.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
1
0.5%
|
0
0%
|
1
0.3%
|
2
0.3%
|
| Asian |
0
0%
|
0
0%
|
4
1%
|
4
0.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
1
0.3%
|
1
0.1%
|
| Black or African American |
31
16.1%
|
19
19.6%
|
49
12.6%
|
99
14.6%
|
| White |
159
82.4%
|
74
76.3%
|
328
84.3%
|
561
82.6%
|
| More than one race |
2
1%
|
4
4.1%
|
6
1.5%
|
12
1.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 190 | 384 |
| Month 6 |
23.7
12.3%
|
62.8
64.7%
|
| Month 12 |
29.1
15.1%
|
63.8
65.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 5.51 | |
| Confidence Interval |
(2-Sided) 95% 3.711 to 8.176 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Month 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 4.33 | |
| Confidence Interval |
(2-Sided) 95% 2.968 to 6.331 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at given time point. Last observation carried forward. Per protocol, the primary comparison for the co-primary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 190 | 384 |
| Month 6 |
36.8
19.1%
|
51.3
52.9%
|
| Month 12 |
42.3
21.9%
|
54.3
56%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Month 6 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.82 | |
| Confidence Interval |
(2-Sided) 95% 1.275 to 2.605 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Month 12 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.007 |
| Comments | P-value for test of difference is from a logistic regression model including treatment as the main effect and baseline value as a covariate. | |
| Method | Regression, Logistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 1.63 | |
| Confidence Interval |
(2-Sided) 95% 1.146 to 2.326 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 111 | 216 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.73
(0.077)
|
-1.73
(0.055)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | mixed model repeated measures (MMRM) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Least Squares (LS) Mean of Difference |
| Estimated Value | -0.99 | |
| Confidence Interval |
(2-Sided) 95% -1.180 to -0.809 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.094 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 138 | 286 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.62
(0.072)
|
-1.64
(0.050)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.02 | |
| Confidence Interval |
(2-Sided) 95% -1.190 to -0.845 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.088 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 170 | 335 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.56
(0.069)
|
-1.54
(0.049)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.99 | |
| Confidence Interval |
(2-Sided) 95% -1.156 to -0.823 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.085 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 111 | 216 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.64
(0.060)
|
-0.86
(0.042)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.367 to -0.080 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.073 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 138 | 286 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.57
(0.051)
|
-0.78
(0.036)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.21 | |
| Confidence Interval |
(2-Sided) 95% -0.329 to -0.085 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.062 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 170 | 335 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.49
(0.046)
|
-0.65
(0.032)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.004 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.16 | |
| Confidence Interval |
(2-Sided) 95% -0.270 to -0.050 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.056 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 146 | 302 |
| Least Squares Mean (Standard Error) [T-score] |
-4.71
(0.739)
|
-7.22
(0.514)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -2.51 | |
| Confidence Interval |
(2-Sided) 95% -4.283 to -0.746 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.900 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 84 | 147 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.60
(0.079)
|
-0.70
(0.058)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.284 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.11 | |
| Confidence Interval |
(2-Sided) 95% -0.298 to 0.088 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.098 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 96 | 209 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.54
(0.076)
|
-0.63
(0.053)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.286 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.10 | |
| Confidence Interval |
(2-Sided) 95% -0.279 to 0.083 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.092 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 119 | 257 |
| Least Squares Mean (Standard Error) [score on a scale] |
-0.40
(0.064)
|
-0.62
(0.045)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.005 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -0.22 | |
| Confidence Interval |
(2-Sided) 95% -0.375 to -0.066 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.079 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Observed cases. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 108 | 220 |
| Least Squares Mean (Standard Error) [T-score] |
-6.43
(0.949)
|
-8.92
(0.665)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | P-value for test of difference at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -2.49 | |
| Confidence Interval |
(2-Sided) 95% -4.773 to -0.216 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.158 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 102 | 202 |
| Least Squares Mean (Standard Error) [score on a scale] |
-3.25
(0.263)
|
-4.39
(0.186)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.14 | |
| Confidence Interval |
(2-Sided) 95% -1.774 to -0.508 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.322 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 130 | 269 |
| Least Squares Mean (Standard Error) [score on a scale] |
-2.74
(0.248)
|
-4.12
(0.174)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.38 | |
| Confidence Interval |
(2-Sided) 95% -1.978 to -0.788 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.303 |
|
| Estimation Comments | ||
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: all randomized participants who received at least 1 dose of study drug. Participants with an assessment. Mixed-effects model repeated measures (MMRM) analysis. Per protocol, the primary comparison for the secondary endpoints was between the elagolix plus E2/NETA and placebo arms only. |
| Arm/Group Title | Placebo | Elagolix + E2/NETA |
|---|---|---|
| Arm/Group Description | Placebo 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 + 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. |
| Measure Participants | 156 | 304 |
| Least Squares Mean (Standard Error) [score on a scale] |
-2.33
(0.225)
|
-3.79
(0.161)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, Elagolix + E2/NETA |
|---|---|---|
| Comments | Ranked secondary endpoints were tested following a fixed-sequence testing procedure. Testing began with testing each of the co-primary endpoints using alpha of 0.05 (2-sided) for elagolix plus E2/NETA compared to placebo. If both co-primary endpoints achieved statistical significance with elagolix plus E2/NETA as compared to placebo, continued testing was performed for the ranked secondary endpoints following a fixed-sequence testing procedure in the order of endpoints presented. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | P value for the test of the difference is from an MMRM with the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous fixed covariate of baseline pain score, and random effect for participant. | |
| Method | MMRM | |
| Comments | ||
| Method of Estimation | Estimation Parameter | LS Mean of Difference |
| Estimated Value | -1.46 | |
| Confidence Interval |
(2-Sided) 95% -2.002 to -0.915 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.276 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | All-cause mortality: from randomization through the end of the Treatment Period (Month 12). Adverse Events (AEs): From first dose of study drug through the end of the Treatment Period (Month 12). | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Treatment emergent AEs (TEAEs) during the 12-Month Placebo-Controlled Treatment Period are presented, and are defined as those that occurred no more than 30 days after the last dose of study drug for participants who discontinued prematurely or until the first dose of the study drug in the Open-Label Treatment. | |||||
| Arm/Group Title | Placebo | Elagolix / Elagolix + E2/NETA | Elagolix + E2/NETA | |||
| Arm/Group Description | Placebo for the 12-month placebo-controlled 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. | Elagolix 200 mg BID + E2/NETA 1 mg/0.5 mg QD for the 12-month placebo-controlled Treatment Period. | |||
All Cause Mortality |
||||||
| Placebo | Elagolix / Elagolix + E2/NETA | Elagolix + E2/NETA | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/194 (0%) | 0/98 (0%) | 0/389 (0%) | |||
Serious Adverse Events |
||||||
| Placebo | Elagolix / Elagolix + E2/NETA | Elagolix + E2/NETA | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/193 (4.1%) | 2/97 (2.1%) | 13/389 (3.3%) | |||
| Cardiac disorders | ||||||
| SINUS NODE DYSFUNCTION | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Ear and labyrinth disorders | ||||||
| VESTIBULAR DISORDER | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Endocrine disorders | ||||||
| PITUITARY APOPLEXY | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Gastrointestinal disorders | ||||||
| PANCREATITIS | 1/193 (0.5%) | 1 | 0/97 (0%) | 0 | 0/389 (0%) | 0 |
| PNEUMOPERITONEUM | 0/193 (0%) | 0 | 1/97 (1%) | 1 | 0/389 (0%) | 0 |
| UMBILICAL HERNIA | 1/193 (0.5%) | 1 | 0/97 (0%) | 0 | 0/389 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| BILIARY COLIC | 1/193 (0.5%) | 1 | 0/97 (0%) | 0 | 0/389 (0%) | 0 |
| CHOLECYSTITIS CHRONIC | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Infections and infestations | ||||||
| ABSCESS INTESTINAL | 0/193 (0%) | 0 | 1/97 (1%) | 1 | 0/389 (0%) | 0 |
| URINARY TRACT INFECTION | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Metabolism and nutrition disorders | ||||||
| DIABETIC KETOACIDOSIS | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| SPONDYLOLISTHESIS | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| PITUITARY TUMOUR | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Nervous system disorders | ||||||
| MIGRAINE | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| TRANSIENT ISCHAEMIC ATTACK | 1/193 (0.5%) | 1 | 0/97 (0%) | 0 | 0/389 (0%) | 0 |
| VESTIBULAR MIGRAINE | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Pregnancy, puerperium and perinatal conditions | ||||||
| ABORTION SPONTANEOUS | 1/193 (0.5%) | 1 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| ECTOPIC PREGNANCY | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Psychiatric disorders | ||||||
| ANXIETY | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| PANIC ATTACK | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| SUICIDE ATTEMPT | 0/193 (0%) | 0 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
| Reproductive system and breast disorders | ||||||
| ENDOMETRIOSIS | 2/193 (1%) | 2 | 1/97 (1%) | 1 | 0/389 (0%) | 0 |
| Surgical and medical procedures | ||||||
| ABORTION INDUCED | 1/193 (0.5%) | 1 | 0/97 (0%) | 0 | 1/389 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Placebo | Elagolix / Elagolix + E2/NETA | Elagolix + E2/NETA | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 72/193 (37.3%) | 73/97 (75.3%) | 209/389 (53.7%) | |||
| Gastrointestinal disorders | ||||||
| NAUSEA | 12/193 (6.2%) | 12 | 17/97 (17.5%) | 20 | 51/389 (13.1%) | 55 |
| General disorders | ||||||
| FATIGUE | 7/193 (3.6%) | 7 | 5/97 (5.2%) | 5 | 17/389 (4.4%) | 17 |
| Infections and infestations | ||||||
| GASTROENTERITIS VIRAL | 2/193 (1%) | 2 | 5/97 (5.2%) | 5 | 9/389 (2.3%) | 9 |
| NASOPHARYNGITIS | 6/193 (3.1%) | 10 | 5/97 (5.2%) | 5 | 21/389 (5.4%) | 24 |
| SINUSITIS | 13/193 (6.7%) | 14 | 10/97 (10.3%) | 10 | 32/389 (8.2%) | 34 |
| UPPER RESPIRATORY TRACT INFECTION | 7/193 (3.6%) | 7 | 7/97 (7.2%) | 8 | 17/389 (4.4%) | 18 |
| URINARY TRACT INFECTION | 9/193 (4.7%) | 10 | 9/97 (9.3%) | 10 | 15/389 (3.9%) | 15 |
| Metabolism and nutrition disorders | ||||||
| VITAMIN D DEFICIENCY | 10/193 (5.2%) | 10 | 2/97 (2.1%) | 2 | 7/389 (1.8%) | 7 |
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRALGIA | 4/193 (2.1%) | 4 | 6/97 (6.2%) | 6 | 14/389 (3.6%) | 16 |
| BACK PAIN | 3/193 (1.6%) | 3 | 1/97 (1%) | 1 | 22/389 (5.7%) | 22 |
| Nervous system disorders | ||||||
| HEADACHE | 10/193 (5.2%) | 10 | 13/97 (13.4%) | 13 | 45/389 (11.6%) | 46 |
| Psychiatric disorders | ||||||
| INSOMNIA | 1/193 (0.5%) | 1 | 9/97 (9.3%) | 9 | 13/389 (3.3%) | 15 |
| MOOD SWINGS | 2/193 (1%) | 2 | 4/97 (4.1%) | 4 | 21/389 (5.4%) | 21 |
| Reproductive system and breast disorders | ||||||
| METRORRHAGIA | 2/193 (1%) | 2 | 8/97 (8.2%) | 8 | 17/389 (4.4%) | 19 |
| Skin and subcutaneous tissue disorders | ||||||
| ACNE | 7/193 (3.6%) | 7 | 5/97 (5.2%) | 5 | 17/389 (4.4%) | 17 |
| NIGHT SWEATS | 6/193 (3.1%) | 6 | 13/97 (13.4%) | 14 | 24/389 (6.2%) | 24 |
| Vascular disorders | ||||||
| HOT FLUSH | 14/193 (7.3%) | 15 | 43/97 (44.3%) | 44 | 69/389 (17.7%) | 74 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03213457
Other Study ID Numbers:
- M14-702
First Posted:
Jul 11, 2017
Last Update Posted:
Feb 16, 2022
Last Verified:
Feb 1, 2022