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Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

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ClinicalTrials.gov Identifier: NCT02654054
Recruitment Status : Completed
First Posted : January 13, 2016
Results First Posted : June 29, 2020
Last Update Posted : June 29, 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: Elagolix
Drug: Placebo for Estradiol/Norethindrone Acetate
Drug: Estradiol/Norethindrone Acetate
Drug: Placebo for Elagolix
Enrollment 413
Recruitment Details  
Pre-assignment Details Eligible participants were randomized in a 1:1:2 ratio to 1 of 3 treatment groups: placebo, elagolix 300 mg BID, or elagolix 300 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) once daily (QD).
Arm/Group Title Placebo Elagolix Elagolix + E2/NETA
Hide Arm/Group Description Placebo for both elagolix BID and E2/NETA QD Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Period Title: Treatment Period
Started [1] 102 104 207
Randomized and Treated 102 104 206
Completed [2] 83 81 164
Not Completed 19 23 43
[1]
randomized
[2]
completed treatment period
Period Title: Post-Treatment Follow-Up Period
Started 25 32 59
Completed 17 24 29
Not Completed 8 8 30
Reason Not Completed
Withdrawal by Subject             2             6             7
Lost to Follow-up             3             0             13
Required Surgery/Invasive Intervention             2             2             2
Other             1             0             4
Non-Compliance             0             0             4
Arm/Group Title Placebo Elagolix Elagolix + E2/NETA Total
Hide Arm/Group Description Placebo for both elagolix BID and E2/NETA QD Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD Total of all reporting groups
Overall Number of Baseline Participants 102 104 206 412
Hide Baseline Analysis Population Description
All randomized and treated participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 104 participants 206 participants 412 participants
41.6  (5.68) 42.6  (5.16) 42.6  (5.30) 42.3  (5.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 104 participants 206 participants 412 participants
Female
102
 100.0%
104
 100.0%
206
 100.0%
412
 100.0%
Male
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 102 participants 104 participants 206 participants 412 participants
Hispanic or Latino
19
  18.6%
4
   3.8%
34
  16.5%
57
  13.8%
Not Hispanic or Latino
83
  81.4%
100
  96.2%
172
  83.5%
355
  86.2%
Unknown or Not Reported
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 102 participants 104 participants 206 participants 412 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
2
   1.0%
2
   0.5%
Asian
1
   1.0%
2
   1.9%
3
   1.5%
6
   1.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.2%
Black or African American
70
  68.6%
69
  66.3%
141
  68.4%
280
  68.0%
White
30
  29.4%
27
  26.0%
59
  28.6%
116
  28.2%
More than one race
1
   1.0%
4
   3.8%
1
   0.5%
6
   1.5%
Unknown or Not Reported
0
   0.0%
1
   1.0%
0
   0.0%
1
   0.2%
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 Reference Day, which is defined as the last visit date during the Treatment Period [last treatment visit date] or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on 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 Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants.
Arm/Group Title Placebo Elagolix Elagolix + E2/NETA
Hide Arm/Group Description:
Placebo for both elagolix BID and E2/NETA QD
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Overall Number of Participants Analyzed 102 104 206
Measure Type: Number
Unit of Measure: percentage of participants
8.7 84.1 68.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 56.79
Confidence Interval (2-Sided) 95%
23.002 to 140.227
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix + E2/NETA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value for test of difference is by pooling the results from a logistic regression model including treatment as the main effect and baseline MBL volume as a covariate in each data set from multiple imputation.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 22.98
Confidence Interval (2-Sided) 95%
10.466 to 50.451
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in MBL Volume to the Final Month
Hide Description

Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, 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.

The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.

Time Frame Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants.
Arm/Group Title Placebo Elagolix Elagolix + E2/NETA
Hide Arm/Group Description:
Placebo for both elagolix BID and E2/NETA QD
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Overall Number of Participants Analyzed 102 104 206
Least Squares Mean (Standard Error)
Unit of Measure: mL
0.8  (14.86) -221.5  (14.49) -176.7  (10.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -222.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 20.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix + E2/NETA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value for test of difference between each elagolix treatment group and placebo is by pooling the results from an ANCOVA model with treatment as the main effect and baseline MBL volume as a covariate in each dataset from multiple imputation.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -177.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 18.24
Estimation Comments [Not Specified]
3.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.

The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.

Time Frame Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants with an assessment
Arm/Group Title Placebo Elagolix Elagolix + E2/NETA
Hide Arm/Group Description:
Placebo for both elagolix BID and E2/NETA QD
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Overall Number of Participants Analyzed 91 94 183
Measure Type: Number
Unit of Measure: percentage of participants
4.4 84.0 56.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count < 5).
Method Chi-square or Fisher's exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Between-Group Difference (%)
Estimated Value 79.6
Confidence Interval (2-Sided) 95%
71.13 to 88.16
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix + E2/NETA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count < 5).
Method Chi-square or Fisher's exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Between-Group Difference (%)
Estimated Value 52.4
Confidence Interval (2-Sided) 95%
44.11 to 60.76
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in MBL Volume to Month 6
Hide Description [Not Specified]
Time Frame Month 0 (Baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix Elagolix + E2/NETA
Hide Arm/Group Description:
Placebo for both elagolix BID and E2/NETA QD
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Overall Number of Participants Analyzed 71 67 132
Least Squares Mean (Standard Error)
Unit of Measure: mL
-2.3  (13.53) -236.2  (13.74) -194.7  (9.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -234.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 19.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix + E2/NETA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is from mixed models repeated measures (MMRM) with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -192.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 16.70
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in MBL Volume to Month 3
Hide Description [Not Specified]
Time Frame Month 0 (Baseline), Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix Elagolix + E2/NETA
Hide Arm/Group Description:
Placebo for both elagolix BID and E2/NETA QD
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Overall Number of Participants Analyzed 85 83 172
Least Squares Mean (Standard Error)
Unit of Measure: mL
6.1  (15.32) -234.7  (15.38) -192.2  (10.81)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -240.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 21.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix + E2/NETA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -198.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 18.76
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6
Hide Description [Not Specified]
Time Frame Month 0 (Baseline), Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants with baseline hemoglobin <= 10.5 g/dL and an assessment at Month 6.
Arm/Group Title Placebo Elagolix Elagolix + E2/NETA
Hide Arm/Group Description:
Placebo for both elagolix BID and E2/NETA QD
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Overall Number of Participants Analyzed 31 41 52
Measure Type: Number
Unit of Measure: percentage of participants
16.1 65.9 61.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count < 5).
Method chi-square or Fisher's exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Between-Group Difference (%)
Estimated Value 49.7
Confidence Interval (2-Sided) 95%
30.27 to 69.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix + E2/NETA
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is calculated based on chi-square test (or Fisher's exact test if ≥ 20% of the cells have expected cell count < 5).
Method chi-square or Fisher's exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Between-Group Difference (%)
Estimated Value 45.4
Confidence Interval (2-Sided) 95%
26.90 to 63.92
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in MBL Volume to Month 1
Hide Description [Not Specified]
Time Frame Month 0 (Baseline), Month 1
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized and treated participants with an assessment at given time point.
Arm/Group Title Placebo Elagolix Elagolix + Estradiol/Norethindrone Acetate
Hide Arm/Group Description:
Placebo for both elagolix BID and E2/NETA QD
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
Overall Number of Participants Analyzed 95 97 187
Least Squares Mean (Standard Error)
Unit of Measure: mL
-19.0  (16.05) -209.0  (15.91) -135.2  (11.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -190.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 22.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix + Estradiol/Norethindrone Acetate
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments The P value is from MMRM with treatment, month, and an interaction between treatment and month as fixed effect factors, and baseline MBL volume as a covariate comparing each elagolix treatment group with placebo.
Method mixed model repeated measures
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -116.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 19.70
Estimation Comments [Not Specified]
Time Frame From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Adverse Event Reporting Description Treatment-emergent adverse events are presented.
 
Arm/Group Title Placebo Elagolix Elagolix + E2-NETA
Hide Arm/Group Description Placebo for both elagolix BID and E2/NETA QD Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
All-Cause Mortality
Placebo Elagolix Elagolix + E2-NETA
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)      0/104 (0.00%)      0/206 (0.00%)    
Hide Serious Adverse Events
Placebo Elagolix Elagolix + E2-NETA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/102 (4.90%)      3/104 (2.88%)      3/206 (1.46%)    
Blood and lymphatic system disorders       
ANAEMIA  1  2/102 (1.96%)  2 0/104 (0.00%)  0 0/206 (0.00%)  0
General disorders       
PROLAPSE  1  0/102 (0.00%)  0 1/104 (0.96%)  1 0/206 (0.00%)  0
Investigations       
OXYGEN SATURATION DECREASED  1  1/102 (0.98%)  1 0/104 (0.00%)  0 0/206 (0.00%)  0
Musculoskeletal and connective tissue disorders       
EXOSTOSIS  1  0/102 (0.00%)  0 0/104 (0.00%)  0 1/206 (0.49%)  1
INTERVERTEBRAL DISC PROTRUSION  1  0/102 (0.00%)  0 0/104 (0.00%)  0 1/206 (0.49%)  1
OSTEOARTHRITIS  1  1/102 (0.98%)  1 0/104 (0.00%)  0 0/206 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
UTERINE LEIOMYOMA  1  0/102 (0.00%)  0 2/104 (1.92%)  2 0/206 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
ABORTION SPONTANEOUS  1  0/102 (0.00%)  0 1/104 (0.96%)  1 0/206 (0.00%)  0
ECTOPIC PREGNANCY  1  0/102 (0.00%)  0 1/104 (0.96%)  1 0/206 (0.00%)  0
Psychiatric disorders       
SUICIDAL IDEATION  1  1/102 (0.98%)  1 0/104 (0.00%)  0 0/206 (0.00%)  0
Reproductive system and breast disorders       
MENORRHAGIA  1  1/102 (0.98%)  1 1/104 (0.96%)  1 0/206 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
DYSPNOEA EXERTIONAL  1  1/102 (0.98%)  1 0/104 (0.00%)  0 0/206 (0.00%)  0
Skin and subcutaneous tissue disorders       
DERMATITIS  1  0/102 (0.00%)  0 0/104 (0.00%)  0 1/206 (0.49%)  1
PALMOPLANTAR KERATODERMA  1  0/102 (0.00%)  0 0/104 (0.00%)  0 1/206 (0.49%)  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 Elagolix + E2-NETA
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/102 (28.43%)      81/104 (77.88%)      96/206 (46.60%)    
Gastrointestinal disorders       
NAUSEA  1  10/102 (9.80%)  10 7/104 (6.73%)  7 23/206 (11.17%)  26
General disorders       
FATIGUE  1  2/102 (1.96%)  2 1/104 (0.96%)  1 14/206 (6.80%)  14
Infections and infestations       
NASOPHARYNGITIS  1  4/102 (3.92%)  5 6/104 (5.77%)  6 10/206 (4.85%)  12
Nervous system disorders       
HEADACHE  1  9/102 (8.82%)  11 17/104 (16.35%)  20 17/206 (8.25%)  18
Psychiatric disorders       
INSOMNIA  1  6/102 (5.88%)  6 7/104 (6.73%)  7 5/206 (2.43%)  5
MOOD SWINGS  1  2/102 (1.96%)  2 7/104 (6.73%)  7 8/206 (3.88%)  8
Reproductive system and breast disorders       
DYSMENORRHOEA  1  4/102 (3.92%)  4 1/104 (0.96%)  1 13/206 (6.31%)  13
METRORRHAGIA  1  0/102 (0.00%)  0 1/104 (0.96%)  1 13/206 (6.31%)  13
Skin and subcutaneous tissue disorders       
NIGHT SWEATS  1  3/102 (2.94%)  3 28/104 (26.92%)  31 14/206 (6.80%)  15
Vascular disorders       
HOT FLUSH  1  9/102 (8.82%)  10 67/104 (64.42%)  72 42/206 (20.39%)  44
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: NCT02654054    
Other Study ID Numbers: M12-815
First Submitted: January 8, 2016
First Posted: January 13, 2016
Results First Submitted: June 9, 2020
Results First Posted: June 29, 2020
Last Update Posted: June 29, 2020