An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Study Details
Study Description
Brief Summary
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Elagolix plus Estradiol/Norethindrone Acetate (E2/NETA) Elagolix 300 mg twice daily (BID) and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) |
Drug: Estradiol/Norethindrone Acetate
capsules
Drug: Elagolix
film-coated tablets
Other Names:
|
Experimental: Elagolix Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD |
Drug: Elagolix
film-coated tablets
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Meeting the Criteria for Responder [From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)]
Percentage of responders, defined as participants who met the following conditions: Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
Secondary Outcome Measures
- Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period [Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)]
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
- Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period [Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)]
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
- Percentage of Participants With Suppression of Bleeding at the Final Month [Final Month of Treatment Period (up through Month 6)]
Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.
- Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period [Month 6]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817).
-
Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study
-
Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study.
-
Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.
Exclusion Criteria:
-
Participant met criteria for removal from therapy in her respective Pivotal Study.
-
Participant is planning a pregnancy within the next 18 months.
-
Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study.
-
Participant has any new medical conditions that may be unsuitable for participation.
-
Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alabama Clinical Therapeutics, LLC /ID# 153217 | Birmingham | Alabama | United States | 35235-3430 |
2 | Alabama Clinical Therapeutics, LLC /ID# 153336 | Birmingham | Alabama | United States | 35235-3430 |
3 | Choice Research, LLC /ID# 153492 | Dothan | Alabama | United States | 36303 |
4 | Brown, Pearson, Guepet Gynecology /ID# 153278 | Fairhope | Alabama | United States | 36532 |
5 | University of South Alabama /ID# 153415 | Mobile | Alabama | United States | 36604-3302 |
6 | Mobile, Ob-Gyn, P.C. /ID# 153442 | Mobile | Alabama | United States | 36608 |
7 | Mesa Obstetricians and Gynecol /ID# 153269 | Mesa | Arizona | United States | 85209 |
8 | Core Healthcare Group /ID# 153282 | Cerritos | California | United States | 90703 |
9 | Diagnamics Inc. /ID# 153347 | Encinitas | California | United States | 92024 |
10 | Grossmont Ctr Clin Research /ID# 153324 | La Mesa | California | United States | 91942 |
11 | Futura Research, Inc. /ID# 153345 | Norwalk | California | United States | 90650 |
12 | Farid Yasharpour MD Medical Co /ID# 153482 | San Fernando | California | United States | 91340 |
13 | Advanced Women's Health Institution /ID# 153401 | Greenwood Village | Colorado | United States | 80111 |
14 | Medstar Health Research Institute /ID# 153321 | Washington | District of Columbia | United States | 20010 |
15 | Emerson Clinical Research Inst /ID# 162755 | Washington | District of Columbia | United States | 20011 |
16 | James A. Simon, MD, PC /ID# 153323 | Washington | District of Columbia | United States | 20036 |
17 | Helix Biomedics, LLC /ID# 153440 | Boynton Beach | Florida | United States | 33436-6634 |
18 | Brandon Premier Health Care, PA /ID# 165791 | Brandon | Florida | United States | 33510-3107 |
19 | Florida Fertility Institute /ID# 153308 | Clearwater | Florida | United States | 33759 |
20 | Omega Research Consultants, LLC /ID# 153381 | DeBary | Florida | United States | 32713-2260 |
21 | KO Clinical Research, LLC /ID# 153198 | Fort Lauderdale | Florida | United States | 33316 |
22 | Clinical Physiology Assoc. /ID# 153444 | Fort Myers | Florida | United States | 33916 |
23 | Solutions Through Adv Rch /ID# 153283 | Jacksonville | Florida | United States | 32256 |
24 | Meridien Research /ID# 153310 | Kenneth City | Florida | United States | 33709-3113 |
25 | Altus Research, Inc /ID# 153307 | Lake Worth | Florida | United States | 33461 |
26 | South Florida Wellness & Clinic /ID# 153420 | Margate | Florida | United States | 33063 |
27 | Precision Research Org, LLC /ID# 153276 | Miami Lakes | Florida | United States | 33016-1501 |
28 | LCC Medical Research Institute /ID# 153296 | Miami | Florida | United States | 33126 |
29 | Invictus Clinical Research Group,LLC /ID# 153196 | Miami | Florida | United States | 33144 |
30 | Healthcare Clinical Data, Inc /ID# 153425 | Miami | Florida | United States | 33161 |
31 | Ocean Blue Med Research Ctr /ID# 153225 | Miami | Florida | United States | 33166 |
32 | Suncoast Clinical Research /ID# 153206 | New Port Richey | Florida | United States | 34652 |
33 | Advanced Research Institute /ID# 153413 | New Port Richey | Florida | United States | 34653 |
34 | Clinical Associates of Orlando /ID# 153427 | Orlando | Florida | United States | 32806 |
35 | Unified Womens Clin Research /ID# 153229 | Panama City | Florida | United States | 32045 |
36 | All Wmns HC of West Broward /ID# 153434 | Plantation | Florida | United States | 33324 |
37 | Oncova Clinical Research, Inc. /ID# 153497 | Saint Cloud | Florida | United States | 34769 |
38 | Physician Care Clin. Res., LLC /ID# 153210 | Sarasota | Florida | United States | 34239 |
39 | Qps-Mra, Llc /Id# 153456 | South Miami | Florida | United States | 33143 |
40 | University of South Florida /ID# 153271 | Tampa | Florida | United States | 33612 |
41 | Axcess Medical Research /ID# 153500 | Wellington | Florida | United States | 33414 |
42 | Virtus Research Consultant,LLC /ID# 153398 | Wellington | Florida | United States | 33414 |
43 | Comprehensive Clinical Trials /ID# 153350 | West Palm Beach | Florida | United States | 33409 |
44 | Atlanta Medical Research Insti /ID# 153298 | Alpharetta | Georgia | United States | 30005-4419 |
45 | Paramount Research Solutions /ID# 153424 | Alpharetta | Georgia | United States | 30005 |
46 | Paramount Research Solutions /ID# 160974 | Alpharetta | Georgia | United States | 30005 |
47 | Mount Vernon Clinical Res, LLC /ID# 153403 | Atlanta | Georgia | United States | 30328 |
48 | Atlanta Women's Research Inst /ID# 153212 | Atlanta | Georgia | United States | 30342 |
49 | Masters of Clinical Research, Inc. /ID# 153295 | Augusta | Georgia | United States | 30909 |
50 | Paramount Research Solutions /ID# 153351 | College Park | Georgia | United States | 30349 |
51 | Fellows Research Alliance, Inc /ID# 153227 | Savannah | Georgia | United States | 31406 |
52 | Clinical Research Consultants of Atlanta /ID# 153285 | Suwanee | Georgia | United States | 30024-6988 |
53 | Atlanta Gynecology Research Institute /ID# 200074 | Suwanee | Georgia | United States | 30024-7159 |
54 | Sonora Clinical Research /ID# 153231 | Meridian | Idaho | United States | 83646-1144 |
55 | Affinity Clinical Research /ID# 153417 | Oak Brook | Illinois | United States | 60523 |
56 | Bluegrass Clinical Research /ID# 153280 | Louisville | Kentucky | United States | 40291 |
57 | Clinical Trials Management, LLC - Covington /ID# 153211 | Covington | Louisiana | United States | 70433 |
58 | Clinical Trials Management, LLC - Covington /ID# 153439 | Covington | Louisiana | United States | 70433 |
59 | Ochsner Baptist Medical Center /ID# 153459 | New Orleans | Louisiana | United States | 70115 |
60 | Omni Fertility and Laser Insti /ID# 153228 | Shreveport | Louisiana | United States | 71118 |
61 | Baltimore Suburban Health /ID# 168386 | Baltimore | Maryland | United States | 21208 |
62 | NECCR Fall River LLC /ID# 153274 | Fall River | Massachusetts | United States | 02720-2972 |
63 | Genesis Clinical Research /ID# 153379 | Fall River | Massachusetts | United States | 02720 |
64 | Great Lakes Research Group,Inc /ID# 153302 | Bay City | Michigan | United States | 48706 |
65 | Saginaw Valley Med Res Group /ID# 153498 | Saginaw | Michigan | United States | 48604 |
66 | Wayne State University Physician Group - Southfield /ID# 153418 | Southfield | Michigan | United States | 48034 |
67 | Accent Clinical Trials /ID# 153474 | Las Vegas | Nevada | United States | 89106-4017 |
68 | Office of Edmond E. Pack, MD /ID# 153411 | Las Vegas | Nevada | United States | 89113 |
69 | Mabey, Las Vegas, NV /ID# 153314 | Las Vegas | Nevada | United States | 89128 |
70 | Lawrence OB/GYN /ID# 153218 | Lawrenceville | New Jersey | United States | 08648 |
71 | Jersey Shore University Medical Center /ID# 153495 | Neptune | New Jersey | United States | 07753-4859 |
72 | Bosque Women's Care /ID# 153223 | Albuquerque | New Mexico | United States | 87109 |
73 | SUNY Downstate Medical Center /ID# 153344 | Brooklyn | New York | United States | 11203 |
74 | Manhattan Medical Research /ID# 153386 | New York | New York | United States | 10016-6023 |
75 | Weill Cornell Medicine /ID# 153275 | New York | New York | United States | 10032-3725 |
76 | Cwrwc /Id# 153313 | Durham | North Carolina | United States | 27713 |
77 | Unified Women's Clinical Research-Greensboro /ID# 153499 | Greensboro | North Carolina | United States | 27408 |
78 | Pinewest Ob-Gyn, Inc. /ID# 153197 | High Point | North Carolina | United States | 27262 |
79 | Eastern Carolina Women's Centr /ID# 153341 | New Bern | North Carolina | United States | 28562 |
80 | Unified Women's Clinical Resea /ID# 153312 | Raleigh | North Carolina | United States | 27607 |
81 | Wake Research Associates, LLC /ID# 153402 | Raleigh | North Carolina | United States | 27612 |
82 | Unified Women's Clinical Resea /ID# 153297 | Winston-Salem | North Carolina | United States | 27103 |
83 | Clinical Inquest Center Ltd /ID# 153436 | Beavercreek | Ohio | United States | 45432 |
84 | CTI Clinical Research Center /ID# 153201 | Cincinnati | Ohio | United States | 45212 |
85 | University Hospitals Cleveland /ID# 153450 | Cleveland | Ohio | United States | 44106 |
86 | University of Toledo /ID# 153409 | Toledo | Ohio | United States | 43614 |
87 | Comprehensive Womens Care /ID# 153396 | Westerville | Ohio | United States | 43081 |
88 | Legacy Medical Group-Portland /ID# 168286 | Portland | Oregon | United States | 97210 |
89 | Main Line Fertility Center /ID# 153410 | Bryn Mawr | Pennsylvania | United States | 19010 |
90 | Penn State University and Milton S. Hershey Medical Center /ID# 153443 | Hershey | Pennsylvania | United States | 17033 |
91 | University of Pennsylvania /ID# 153203 | Philadelphia | Pennsylvania | United States | 19104-5502 |
92 | Thomas Jefferson University /ID# 153319 | Philadelphia | Pennsylvania | United States | 19107-4414 |
93 | Clinical Research of Philadelphia, LLC /ID# 153279 | Philadelphia | Pennsylvania | United States | 19114 |
94 | Reading Hosp Clncl Trials Ofc /ID# 153475 | West Reading | Pennsylvania | United States | 19611 |
95 | Medical University of South Carolina /ID# 153325 | Charleston | South Carolina | United States | 29425 |
96 | Vista Clinical Research /ID# 153399 | Columbia | South Carolina | United States | 29201 |
97 | Chattanooga Medical Research /ID# 153405 | Chattanooga | Tennessee | United States | 37404 |
98 | WR-ClinSearch /ID# 153404 | Chattanooga | Tennessee | United States | 37421-1605 |
99 | Research Memphis Associates, LLC /ID# 153322 | Memphis | Tennessee | United States | 38119-3895 |
100 | Women's Health Trials /ID# 153426 | Menphis | Tennessee | United States | 38104 |
101 | Access Clinical Trials, Inc. /ID# 153441 | Nashville | Tennessee | United States | 37203 |
102 | Lotus Gynecology /ID# 153476 | Austin | Texas | United States | 78703-1448 |
103 | Texas Health Presbyterian Hosp /ID# 153339 | Dallas | Texas | United States | 75231 |
104 | UT Southwestern Medical Center /ID# 153400 | Dallas | Texas | United States | 75390-7208 |
105 | Baylor Scott & White /ID# 153273 | Fort Worth | Texas | United States | 76104-4110 |
106 | Willowbend Health and Wellness /ID# 153458 | Frisco | Texas | United States | 75035 |
107 | Advances in Health, Inc. /ID# 153414 | Houston | Texas | United States | 77030 |
108 | The Woman's Hospital of Texas /ID# 153270 | Houston | Texas | United States | 77054 |
109 | FMC Science /ID# 153289 | Lampasas | Texas | United States | 76550 |
110 | Clinical Trials of Texas,Inc. /ID# 153209 | San Antonio | Texas | United States | 78229 |
111 | Discovery Clinical Trials-San Antonio /ID# 153315 | San Antonio | Texas | United States | 78258 |
112 | Houston Ctr for Clin Research /ID# 153221 | Sugar Land | Texas | United States | 77479 |
113 | Center of Reproductive Medicin /ID# 153320 | Webster | Texas | United States | 77598 |
114 | Tidewater Physicians for Women /ID# 153432 | Norfolk | Virginia | United States | 23502 |
115 | Eastern Virginia Med School /ID# 153380 | Norfolk | Virginia | United States | 23507-1627 |
116 | Clinical Research Partners, LL /ID# 153412 | North Chesterfield | Virginia | United States | 23235-4722 |
117 | Clinical Research Partners, LLC /ID# 153343 | Richmond | Virginia | United States | 23220-4459 |
118 | Clinical Trials Virginia, Inc. /ID# 153419 | Richmond | Virginia | United States | 23225 |
119 | Emerson Clinical Research Inst /ID# 153416 | Vienna | Virginia | United States | 22182 |
120 | Virginia Mason Medical Center /ID# 153342 | Seattle | Washington | United States | 98101 |
121 | Seattle Women's Health, Research, Gynecology /ID# 153306 | Seattle | Washington | United States | 98105 |
122 | Victory Reproductive Care /ID# 153299 | Windsor | Ontario | Canada | N8W 5R7 |
123 | Rodriguez-Ginorio, San Juan /ID# 153328 | San Juan | Puerto Rico | 00917 | |
124 | School of Medicine University of Puerto Rico-Medical Sciences Campus /ID# 153329 | San Juan | Puerto Rico | 00935 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Publications
- M12-816
Study Results
Participant Flow
Recruitment Details | A total of 433 participants who completed the 6-month Treatment Period in pivotal studies M12-815 (NCT02654054) or M12-817 (NCT02691494) were enrolled in this extension study at 114 sites in 2 countries (US [including Puerto Rico] and Canada). |
---|---|
Pre-assignment Detail | A total of 433 participants were treated in this extension study and were grouped according to the treatment assignments in pivotal studies M12-815 and M12-817 and this extension study. |
Arm/Group Title | Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA |
---|---|---|---|---|
Arm/Group Description | Placebo in pivotal study and elagolix 300 mg twice daily (BID) in extension study. | Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) once daily (QD) in extension study. | Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. |
Period Title: Treatment Period | ||||
STARTED | 59 | 58 | 98 | 218 |
COMPLETED | 50 | 43 | 79 | 182 |
NOT COMPLETED | 9 | 15 | 19 | 36 |
Period Title: Treatment Period | ||||
STARTED | 54 | 47 | 88 | 184 |
COMPLETED | 40 | 37 | 64 | 134 |
NOT COMPLETED | 14 | 10 | 24 | 50 |
Baseline Characteristics
Arm/Group Title | Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA | Total |
---|---|---|---|---|---|
Arm/Group Description | Placebo in pivotal study and elagolix 300 mg BID in extension study. | Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | Total of all reporting groups |
Overall Participants | 59 | 58 | 98 | 218 | 433 |
Age, Customized (Count of Participants) | |||||
25 to < 30 years |
0
0%
|
3
5.2%
|
1
1%
|
4
1.8%
|
8
1.8%
|
30 to < 35 years |
4
6.8%
|
2
3.4%
|
7
7.1%
|
19
8.7%
|
32
7.4%
|
35 to < 40 years |
12
20.3%
|
10
17.2%
|
18
18.4%
|
34
15.6%
|
74
17.1%
|
40 to < 45 years |
20
33.9%
|
21
36.2%
|
36
36.7%
|
74
33.9%
|
151
34.9%
|
45 to < 50 years |
16
27.1%
|
16
27.6%
|
30
30.6%
|
77
35.3%
|
139
32.1%
|
>= 50 years |
7
11.9%
|
6
10.3%
|
6
6.1%
|
10
4.6%
|
29
6.7%
|
Sex: Female, Male (Count of Participants) | |||||
Female |
59
100%
|
58
100%
|
98
100%
|
218
100%
|
433
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
7
11.9%
|
7
12.1%
|
9
9.2%
|
33
15.1%
|
56
12.9%
|
Not Hispanic or Latino |
52
88.1%
|
51
87.9%
|
89
90.8%
|
185
84.9%
|
377
87.1%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
2
0.9%
|
2
0.5%
|
Asian |
2
3.4%
|
0
0%
|
1
1%
|
1
0.5%
|
4
0.9%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
43
72.9%
|
39
67.2%
|
70
71.4%
|
146
67%
|
298
68.8%
|
White |
13
22%
|
19
32.8%
|
25
25.5%
|
65
29.8%
|
122
28.2%
|
More than one race |
1
1.7%
|
0
0%
|
1
1%
|
3
1.4%
|
5
1.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
1
1%
|
1
0.5%
|
2
0.5%
|
Outcome Measures
Title | Percentage of Participants Meeting the Criteria for Responder |
---|---|
Description | Percentage of responders, defined as participants who met the following conditions: Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not. |
Time Frame | From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study drug and had an assessment. |
Arm/Group Title | Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA |
---|---|---|---|---|
Arm/Group Description | Placebo in pivotal study and elagolix 300 mg BID in extension study. | Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. |
Measure Participants | 56 | 54 | 94 | 206 |
Number [percentage of participants] |
85.7
145.3%
|
66.7
115%
|
89.4
91.2%
|
87.9
40.3%
|
Title | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period |
---|---|
Description | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. |
Time Frame | Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study drug and had an assessment at given time point. |
Arm/Group Title | Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA |
---|---|---|---|---|
Arm/Group Description | Placebo in pivotal study and elagolix 300 mg BID in extension study. | Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. |
Measure Participants | 56 | 54 | 94 | 206 |
Study Day 1 to 28 |
-151.7
(184.76)
|
-61.7
(212.01)
|
-253.4
(190.07)
|
-186.5
(164.38)
|
Study Day 29 to 56 |
-210.9
(234.01)
|
-203.1
(188.15)
|
-249.7
(189.81)
|
-191.9
(166.38)
|
Study Day 57 to 84 |
-236.9
(162.33)
|
-209.0
(184.90)
|
-255.9
(175.43)
|
-200.6
(159.77)
|
Study Day 85 to 112 |
-235.1
(184.87)
|
-204.5
(177.65)
|
-252.0
(175.23)
|
-200.5
(156.85)
|
Study Day 113 to 140 |
-237.3
(234.00)
|
-194.5
(213.69)
|
-253.9
(173.50)
|
-192.9
(165.42)
|
Study Day 141 to 168 |
-263.8
(199.83)
|
-175.4
(115.43)
|
-279.1
(191.44)
|
-211.4
(165.26)
|
Final Month |
-256.6
(194.04)
|
-186.4
(138.16)
|
-250.3
(182.09)
|
-205.6
(151.55)
|
Title | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period |
---|---|
Description | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. |
Time Frame | Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study drug and had an assessment at given time point. |
Arm/Group Title | Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA |
---|---|---|---|---|
Arm/Group Description | Placebo in pivotal study and elagolix 300 mg BID in extension study. | Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. |
Measure Participants | 56 | 54 | 94 | 206 |
Study Day 1 to 28 |
-46.5
(66.57)
|
-28.2
(72.69)
|
-94.0
(24.90)
|
-87.7
(36.24)
|
Study Day 29 to 56 |
-87.2
(46.33)
|
-79.4
(41.80)
|
-93.3
(28.77)
|
-87.8
(43.17)
|
Study Day 57 to 84 |
-89.9
(37.62)
|
-82.9
(34.79)
|
-96.9
(16.88)
|
-90.6
(32.60)
|
Study Day 85 to 112 |
-90.3
(30.26)
|
-82.7
(32.76)
|
-95.2
(19.38)
|
-91.2
(28.42)
|
Study Day 113 to 140 |
-90.0
(40.38)
|
-75.0
(65.97)
|
-97.7
(13.01)
|
-87.5
(40.67)
|
Study Day 141 to 168 |
-91.8
(30.77)
|
-79.3
(32.25)
|
-99.2
(4.31)
|
-89.7
(36.67)
|
Final Month |
-91.0
(28.74)
|
-78.5
(36.76)
|
-96.6
(18.29)
|
-90.8
(33.01)
|
Title | Percentage of Participants With Suppression of Bleeding at the Final Month |
---|---|
Description | Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11. |
Time Frame | Final Month of Treatment Period (up through Month 6) |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study drug and had an assessment. |
Arm/Group Title | Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix->Elagolix + E2/NETA |
---|---|---|---|---|
Arm/Group Description | Placebo in pivotal study and elagolix 300 mg BID in extension study. | Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. |
Measure Participants | 53 | 50 | 93 | 206 |
Number [percentage of participants] |
88.7
150.3%
|
56.0
96.6%
|
89.2
91%
|
74.8
34.3%
|
Title | Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period |
---|---|
Description | |
Time Frame | Month 6 |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study drug, had a baseline hemoglobin concentration of <= 10.5 g/dL and had an assessment. |
Arm/Group Title | Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA |
---|---|---|---|---|
Arm/Group Description | Placebo in pivotal study and elagolix 300 mg BID in extension study. | Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. |
Measure Participants | 17 | 11 | 28 | 51 |
Number [percentage of participants] |
70.6
119.7%
|
36.4
62.8%
|
71.4
72.9%
|
72.5
33.3%
|
Adverse Events
Time Frame | From the first dose date in Study M12-816 through up to 30 days after the last dose date. Mean (SD) treatment exposure in M12-816 was 153.7 (44.55), 145.0 (49.00), 156.5 (36.27) and 157.6 (36.11) days for the Placebo->Elagolix, Placebo->Elagolix + E2/NETA, Elagolix->Elagolix, and Elagolix + E2/NETA->Elagolix + E2/NETA arms, respectively | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | Treatment-emergent adverse events are presented. | |||||||
Arm/Group Title | Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA | ||||
Arm/Group Description | Placebo in pivotal study and elagolix 300 mg BID in extension study. | Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | ||||
All Cause Mortality |
||||||||
Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/59 (0%) | 1/58 (1.7%) | 0/98 (0%) | 0/218 (0%) | ||||
Serious Adverse Events |
||||||||
Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/59 (1.7%) | 3/58 (5.2%) | 2/98 (2%) | 6/218 (2.8%) | ||||
Gastrointestinal disorders | ||||||||
ABDOMINAL PAIN | 1/59 (1.7%) | 1 | 0/58 (0%) | 0 | 0/98 (0%) | 0 | 0/218 (0%) | 0 |
Hepatobiliary disorders | ||||||||
CHOLECYSTITIS ACUTE | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 1/98 (1%) | 1 | 0/218 (0%) | 0 |
CHOLELITHIASIS | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 1/98 (1%) | 1 | 0/218 (0%) | 0 |
Infections and infestations | ||||||||
PILONIDAL CYST | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 0/98 (0%) | 0 | 1/218 (0.5%) | 1 |
SEPSIS | 0/59 (0%) | 0 | 1/58 (1.7%) | 1 | 0/98 (0%) | 0 | 0/218 (0%) | 0 |
Metabolism and nutrition disorders | ||||||||
OBESITY | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 1/98 (1%) | 1 | 0/218 (0%) | 0 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
BREAST CANCER | 0/59 (0%) | 0 | 1/58 (1.7%) | 1 | 0/98 (0%) | 0 | 0/218 (0%) | 0 |
BREAST CANCER STAGE II | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 0/98 (0%) | 0 | 1/218 (0.5%) | 1 |
Nervous system disorders | ||||||||
FACIAL PARALYSIS | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 0/98 (0%) | 0 | 1/218 (0.5%) | 1 |
Pregnancy, puerperium and perinatal conditions | ||||||||
ABORTION SPONTANEOUS | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 0/98 (0%) | 0 | 1/218 (0.5%) | 1 |
Reproductive system and breast disorders | ||||||||
MENORRHAGIA | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 0/98 (0%) | 0 | 1/218 (0.5%) | 1 |
METRORRHAGIA | 0/59 (0%) | 0 | 1/58 (1.7%) | 1 | 0/98 (0%) | 0 | 0/218 (0%) | 0 |
PELVIC PAIN | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 0/98 (0%) | 0 | 1/218 (0.5%) | 1 |
Surgical and medical procedures | ||||||||
HYSTERECTOMY | 0/59 (0%) | 0 | 0/58 (0%) | 0 | 0/98 (0%) | 0 | 1/218 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
Placebo->Elagolix | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 38/59 (64.4%) | 26/58 (44.8%) | 25/98 (25.5%) | 50/218 (22.9%) | ||||
Blood and lymphatic system disorders | ||||||||
ANAEMIA | 0/59 (0%) | 0 | 3/58 (5.2%) | 3 | 0/98 (0%) | 0 | 2/218 (0.9%) | 2 |
Gastrointestinal disorders | ||||||||
NAUSEA | 5/59 (8.5%) | 5 | 3/58 (5.2%) | 3 | 2/98 (2%) | 2 | 9/218 (4.1%) | 10 |
Infections and infestations | ||||||||
NASOPHARYNGITIS | 1/59 (1.7%) | 2 | 1/58 (1.7%) | 1 | 5/98 (5.1%) | 5 | 9/218 (4.1%) | 11 |
TOOTH INFECTION | 2/59 (3.4%) | 2 | 3/58 (5.2%) | 3 | 0/98 (0%) | 0 | 0/218 (0%) | 0 |
URINARY TRACT INFECTION | 0/59 (0%) | 0 | 3/58 (5.2%) | 3 | 4/98 (4.1%) | 4 | 5/218 (2.3%) | 5 |
Investigations | ||||||||
BONE DENSITY DECREASED | 2/59 (3.4%) | 2 | 2/58 (3.4%) | 2 | 6/98 (6.1%) | 6 | 2/218 (0.9%) | 2 |
Musculoskeletal and connective tissue disorders | ||||||||
ARTHRALGIA | 3/59 (5.1%) | 3 | 2/58 (3.4%) | 2 | 1/98 (1%) | 1 | 3/218 (1.4%) | 3 |
Nervous system disorders | ||||||||
HEADACHE | 4/59 (6.8%) | 4 | 3/58 (5.2%) | 3 | 4/98 (4.1%) | 4 | 12/218 (5.5%) | 12 |
Psychiatric disorders | ||||||||
ANXIETY | 1/59 (1.7%) | 1 | 3/58 (5.2%) | 3 | 1/98 (1%) | 1 | 3/218 (1.4%) | 3 |
MOOD SWINGS | 3/59 (5.1%) | 3 | 2/58 (3.4%) | 2 | 1/98 (1%) | 1 | 2/218 (0.9%) | 2 |
Reproductive system and breast disorders | ||||||||
METRORRHAGIA | 0/59 (0%) | 0 | 4/58 (6.9%) | 4 | 0/98 (0%) | 0 | 1/218 (0.5%) | 1 |
Skin and subcutaneous tissue disorders | ||||||||
ALOPECIA | 3/59 (5.1%) | 3 | 1/58 (1.7%) | 1 | 1/98 (1%) | 1 | 0/218 (0%) | 0 |
NIGHT SWEATS | 15/59 (25.4%) | 16 | 4/58 (6.9%) | 4 | 2/98 (2%) | 2 | 7/218 (3.2%) | 8 |
Vascular disorders | ||||||||
HOT FLUSH | 30/59 (50.8%) | 33 | 4/58 (6.9%) | 4 | 3/98 (3.1%) | 3 | 15/218 (6.9%) | 15 |
Limitations/Caveats
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 |
- M12-816