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An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925494
Recruitment Status : Completed
First Posted : October 6, 2016
Results First Posted : June 30, 2020
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Uterine Fibroids
Heavy Menstrual Bleeding
Interventions Drug: Estradiol/Norethindrone Acetate
Drug: Elagolix
Enrollment 433
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 Details 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
Hide 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: Post-Treatment Follow-Up Period
Started [1] 54 47 88 184
Completed 40 37 64 134
Not Completed 14 10 24 50
Reason Not Completed
Withdrawal by Subject             8             2             8             23
Lost to Follow-up             3             2             9             10
Other             1             4             3             6
Required Surgery/ Invasive Intervention             1             2             2             6
Pregnancy             1             0             1             2
Non-Compliance             0             0             1             2
Adverse Event             0             0             0             1
[1]
Completed or prematurely discontinued the Treatment Period and entered the follow-up period.
Arm/Group Title Placebo->Elagolix Placebo->Elagolix + E2/NETA Elagolix->Elagolix Elagolix + E2/NETA->Elagolix + E2/NETA Total
Hide 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 Number of Baseline Participants 59 58 98 218 433
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 98 participants 218 participants 433 participants
25 to < 30 years
0
   0.0%
3
   5.2%
1
   1.0%
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 98 participants 218 participants 433 participants
Female
59
 100.0%
58
 100.0%
98
 100.0%
218
 100.0%
433
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 98 participants 218 participants 433 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
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 98 participants 218 participants 433 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.9%
2
   0.5%
Asian
2
   3.4%
0
   0.0%
1
   1.0%
1
   0.5%
4
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
43
  72.9%
39
  67.2%
70
  71.4%
146
  67.0%
298
  68.8%
White
13
  22.0%
19
  32.8%
25
  25.5%
65
  29.8%
122
  28.2%
More than one race
1
   1.7%
0
   0.0%
1
   1.0%
3
   1.4%
5
   1.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   1.0%
1
   0.5%
2
   0.5%
1.Primary Outcome
Title Percentage of Participants Meeting the Criteria for Responder
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 56 54 94 206
Measure Type: Number
Unit of Measure: percentage of participants
85.7 66.7 89.4 87.9
2.Secondary Outcome
Title Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 56 54 94 206
Mean (Standard Deviation)
Unit of Measure: mL
Study Day 1 to 28 Number Analyzed 54 participants 51 participants 94 participants 205 participants
-151.7  (184.76) -61.7  (212.01) -253.4  (190.07) -186.5  (164.38)
Study Day 29 to 56 Number Analyzed 51 participants 47 participants 90 participants 205 participants
-210.9  (234.01) -203.1  (188.15) -249.7  (189.81) -191.9  (166.38)
Study Day 57 to 84 Number Analyzed 53 participants 45 participants 92 participants 196 participants
-236.9  (162.33) -209.0  (184.90) -255.9  (175.43) -200.6  (159.77)
Study Day 85 to 112 Number Analyzed 51 participants 45 participants 85 participants 188 participants
-235.1  (184.87) -204.5  (177.65) -252.0  (175.23) -200.5  (156.85)
Study Day 113 to 140 Number Analyzed 49 participants 42 participants 78 participants 181 participants
-237.3  (234.00) -194.5  (213.69) -253.9  (173.50) -192.9  (165.42)
Study Day 141 to 168 Number Analyzed 41 participants 36 participants 57 participants 139 participants
-263.8  (199.83) -175.4  (115.43) -279.1  (191.44) -211.4  (165.26)
Final Month Number Analyzed 56 participants 54 participants 94 participants 206 participants
-256.6  (194.04) -186.4  (138.16) -250.3  (182.09) -205.6  (151.55)
3.Secondary Outcome
Title Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 56 54 94 206
Mean (Standard Deviation)
Unit of Measure: percentage change
Study Day 1 to 28 Number Analyzed 54 participants 51 participants 94 participants 205 participants
-46.5  (66.57) -28.2  (72.69) -94.0  (24.90) -87.7  (36.24)
Study Day 29 to 56 Number Analyzed 51 participants 47 participants 90 participants 205 participants
-87.2  (46.33) -79.4  (41.80) -93.3  (28.77) -87.8  (43.17)
Study Day 57 to 84 Number Analyzed 53 participants 45 participants 92 participants 196 participants
-89.9  (37.62) -82.9  (34.79) -96.9  (16.88) -90.6  (32.60)
Study Day 85 to 112 Number Analyzed 51 participants 45 participants 85 participants 188 participants
-90.3  (30.26) -82.7  (32.76) -95.2  (19.38) -91.2  (28.42)
Study Day 113 to 140 Number Analyzed 49 participants 42 participants 78 participants 181 participants
-90.0  (40.38) -75.0  (65.97) -97.7  (13.01) -87.5  (40.67)
Study Day 141 to 168 Number Analyzed 41 participants 36 participants 57 participants 139 participants
-91.8  (30.77) -79.3  (32.25) -99.2  (4.31) -89.7  (36.67)
Final Month Number Analyzed 56 participants 54 participants 94 participants 206 participants
-91.0  (28.74) -78.5  (36.76) -96.6  (18.29) -90.8  (33.01)
4.Secondary Outcome
Title Percentage of Participants With Suppression of Bleeding at the Final Month
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 53 50 93 206
Measure Type: Number
Unit of Measure: percentage of participants
88.7 56.0 89.2 74.8
5.Secondary Outcome
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
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 17 11 28 51
Measure Type: Number
Unit of Measure: percentage of participants
70.6 36.4 71.4 72.5
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)      1/58 (1.72%)      0/98 (0.00%)      0/218 (0.00%)    
Hide 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 (1.69%)      3/58 (5.17%)      2/98 (2.04%)      6/218 (2.75%)    
Gastrointestinal disorders         
ABDOMINAL PAIN  1  1/59 (1.69%)  1 0/58 (0.00%)  0 0/98 (0.00%)  0 0/218 (0.00%)  0
Hepatobiliary disorders         
CHOLECYSTITIS ACUTE  1  0/59 (0.00%)  0 0/58 (0.00%)  0 1/98 (1.02%)  1 0/218 (0.00%)  0
CHOLELITHIASIS  1  0/59 (0.00%)  0 0/58 (0.00%)  0 1/98 (1.02%)  1 0/218 (0.00%)  0
Infections and infestations         
PILONIDAL CYST  1  0/59 (0.00%)  0 0/58 (0.00%)  0 0/98 (0.00%)  0 1/218 (0.46%)  1
SEPSIS  1  0/59 (0.00%)  0 1/58 (1.72%)  1 0/98 (0.00%)  0 0/218 (0.00%)  0
Metabolism and nutrition disorders         
OBESITY  1  0/59 (0.00%)  0 0/58 (0.00%)  0 1/98 (1.02%)  1 0/218 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
BREAST CANCER  1  0/59 (0.00%)  0 1/58 (1.72%)  1 0/98 (0.00%)  0 0/218 (0.00%)  0
BREAST CANCER STAGE II  1  0/59 (0.00%)  0 0/58 (0.00%)  0 0/98 (0.00%)  0 1/218 (0.46%)  1
Nervous system disorders         
FACIAL PARALYSIS  1  0/59 (0.00%)  0 0/58 (0.00%)  0 0/98 (0.00%)  0 1/218 (0.46%)  1
Pregnancy, puerperium and perinatal conditions         
ABORTION SPONTANEOUS  1  0/59 (0.00%)  0 0/58 (0.00%)  0 0/98 (0.00%)  0 1/218 (0.46%)  1
Reproductive system and breast disorders         
MENORRHAGIA  1  0/59 (0.00%)  0 0/58 (0.00%)  0 0/98 (0.00%)  0 1/218 (0.46%)  1
METRORRHAGIA  1  0/59 (0.00%)  0 1/58 (1.72%)  1 0/98 (0.00%)  0 0/218 (0.00%)  0
PELVIC PAIN  1  0/59 (0.00%)  0 0/58 (0.00%)  0 0/98 (0.00%)  0 1/218 (0.46%)  1
Surgical and medical procedures         
HYSTERECTOMY  1  0/59 (0.00%)  0 0/58 (0.00%)  0 0/98 (0.00%)  0 1/218 (0.46%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (64.41%)      26/58 (44.83%)      25/98 (25.51%)      50/218 (22.94%)    
Blood and lymphatic system disorders         
ANAEMIA  1  0/59 (0.00%)  0 3/58 (5.17%)  3 0/98 (0.00%)  0 2/218 (0.92%)  2
Gastrointestinal disorders         
NAUSEA  1  5/59 (8.47%)  5 3/58 (5.17%)  3 2/98 (2.04%)  2 9/218 (4.13%)  10
Infections and infestations         
NASOPHARYNGITIS  1  1/59 (1.69%)  2 1/58 (1.72%)  1 5/98 (5.10%)  5 9/218 (4.13%)  11
TOOTH INFECTION  1  2/59 (3.39%)  2 3/58 (5.17%)  3 0/98 (0.00%)  0 0/218 (0.00%)  0
URINARY TRACT INFECTION  1  0/59 (0.00%)  0 3/58 (5.17%)  3 4/98 (4.08%)  4 5/218 (2.29%)  5
Investigations         
BONE DENSITY DECREASED  1  2/59 (3.39%)  2 2/58 (3.45%)  2 6/98 (6.12%)  6 2/218 (0.92%)  2
Musculoskeletal and connective tissue disorders         
ARTHRALGIA  1  3/59 (5.08%)  3 2/58 (3.45%)  2 1/98 (1.02%)  1 3/218 (1.38%)  3
Nervous system disorders         
HEADACHE  1  4/59 (6.78%)  4 3/58 (5.17%)  3 4/98 (4.08%)  4 12/218 (5.50%)  12
Psychiatric disorders         
ANXIETY  1  1/59 (1.69%)  1 3/58 (5.17%)  3 1/98 (1.02%)  1 3/218 (1.38%)  3
MOOD SWINGS  1  3/59 (5.08%)  3 2/58 (3.45%)  2 1/98 (1.02%)  1 2/218 (0.92%)  2
Reproductive system and breast disorders         
METRORRHAGIA  1  0/59 (0.00%)  0 4/58 (6.90%)  4 0/98 (0.00%)  0 1/218 (0.46%)  1
Skin and subcutaneous tissue disorders         
ALOPECIA  1  3/59 (5.08%)  3 1/58 (1.72%)  1 1/98 (1.02%)  1 0/218 (0.00%)  0
NIGHT SWEATS  1  15/59 (25.42%)  16 4/58 (6.90%)  4 2/98 (2.04%)  2 7/218 (3.21%)  8
Vascular disorders         
HOT FLUSH  1  30/59 (50.85%)  33 4/58 (6.90%)  4 3/98 (3.06%)  3 15/218 (6.88%)  15
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
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Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02925494    
Other Study ID Numbers: M12-816
First Submitted: September 24, 2016
First Posted: October 6, 2016
Results First Submitted: June 12, 2020
Results First Posted: June 30, 2020
Last Update Posted: July 21, 2020