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Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

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: NCT03951077
Recruitment Status : Completed
First Posted : May 15, 2019
Results First Posted : June 8, 2022
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Polycystic Ovary Syndrome
Interventions Drug: Elagolix
Drug: Placebo
Enrollment 118
Recruitment Details  
Pre-assignment Details Participants were randomized 2:2:2:2:2:3 to the following treatments: 25 mg twice daily (BID), 50 mg once daily (QD), 75 mg BID, 150 mg QD, 300 mg QD, or placebo.
Arm/Group Title Placebo Elagolix 25 mg BID Elagolix 50 mg QD Elagolix 75 mg BID Elagolix 150 mg QD Elagolix 300 mg QD
Hide Arm/Group Description Placebo taken orally BID Elagolix 25 mg taken orally BID plus placebo Elagolix 50 mg taken orally QD plus placebo Elagolix 75 mg taken orally BID plus placebo Elagolix 150 mg taken orally QD plus placebo Elagolix 300 mg taken orally QD plus placebo
Period Title: Overall Study
Started [1] 27 18 18 18 19 18
Randomized and Treated 26 18 17 17 18 18
Completed 9 4 5 6 3 7
Not Completed 18 14 13 12 16 11
Reason Not Completed
Adverse Event             1             0             0             0             0             0
Withdrawal by Subject             3             3             0             3             3             2
Lost to Follow-up             1             1             2             3             2             3
Non-Compliance With Study Procedures             0             0             0             0             1             0
Other, Not Specified             12             10             10             5             9             6
Did Not Receive Any Study Drug             1             0             1             1             1             0
[1]
Randomized
Arm/Group Title Placebo Elagolix 25 mg BID Elagolix 50 mg QD Elagolix 75 mg BID Elagolix 150 mg QD Elagolix 300 mg QD Total
Hide Arm/Group Description Placebo taken orally BID Elagolix 25 mg taken orally BID plus placebo Elagolix 50 mg taken orally QD plus placebo Elagolix 75 mg taken orally BID plus placebo Elagolix 150 mg taken orally QD plus placebo Elagolix 300 mg taken orally QD plus placebo Total of all reporting groups
Overall Number of Baseline Participants 26 18 17 17 18 18 114
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 18 participants 17 participants 17 participants 18 participants 18 participants 114 participants
27.8  (4.60) 25.3  (5.19) 27.6  (4.85) 26.9  (3.27) 25.1  (4.19) 26.1  (4.35) 26.5  (4.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 18 participants 17 participants 17 participants 18 participants 18 participants 114 participants
Female 26 18 17 17 18 18 114
Male 0 0 0 0 0 0 0
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 18 participants 17 participants 17 participants 18 participants 18 participants 114 participants
Hispanic or Latino 5 5 6 3 4 4 27
Not Hispanic or Latino 21 13 11 14 14 14 87
Unknown or Not Reported 0 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 18 participants 17 participants 17 participants 18 participants 18 participants 114 participants
American Indian or Alaska Native 0 0 0 0 0 0 0
Asian 0 0 0 0 0 0 0
Native Hawaiian or Other Pacific Islander 0 1 0 0 0 0 1
Black or African American 6 4 1 5 7 4 27
White 19 13 16 12 11 14 85
More than one race 1 0 0 0 0 0 1
Unknown or Not Reported 0 0 0 0 0 0 0
Body Mass Index (BMI)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 18 participants 17 participants 17 participants 18 participants 18 participants 114 participants
< 30 kg/m^2 8 5 5 5 5 5 33
≥ 30 kg/m^2 18 13 12 12 13 13 81
1.Primary Outcome
Title Percentage of Menstrual Cycle Responders
Hide Description A participant was considered a menstrual cycle responder if she has at least 2 normal menstrual cycles during the final 4 months of the treatment period. In addition, a participant was considered a complete menstrual cycle responder if she has normal menstrual cycles beginning at or before Month 3 that are maintained through Month 6 during the treatment period.
Time Frame Week 0 (Baseline) to Week 24 (Month 6)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Based on observed cases only.
Arm/Group Title Placebo Elagolix 25 mg BID Elagolix 50 mg QD Elagolix 75 mg BID Elagolix 150 mg QD Elagolix 300 mg QD
Hide Arm/Group Description:
Placebo taken orally BID
Elagolix 25 mg taken orally BID plus placebo
Elagolix 50 mg taken orally QD plus placebo
Elagolix 75 mg taken orally BID plus placebo
Elagolix 150 mg taken orally QD plus placebo
Elagolix 300 mg taken orally QD plus placebo
Overall Number of Participants Analyzed 26 18 17 17 18 18
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
7.7
(0.00 to 16.29)
0
(0.00 to 0.00)
0
(0.00 to 0.00)
0
(0.00 to 0.00)
0
(0.00 to 0.00)
5.6
(0.00 to 14.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 25 mg BID
Comments Across the strata, 90% confidence interval (CI) for adjusted difference and p-value were calculated according to the Cochran-Mantel-Haenszel (CMH) test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.300
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Response Rate Difference
Estimated Value -5.9
Confidence Interval (2-Sided) 90%
-15.38 to 3.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 50 mg QD
Comments Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Response Rate Difference
Estimated Value -5.9
Confidence Interval (2-Sided) 90%
-15.65 to 3.86
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 75 mg BID
Comments Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.315
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Response Rate Difference
Estimated Value -5.6
Confidence Interval (2-Sided) 90%
-14.87 to 3.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.265
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Response Rate Difference
Estimated Value -6.7
Confidence Interval (2-Sided) 90%
-16.63 to 3.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 300 mg QD
Comments Across the strata, 90% CI for adjusted difference and p-value were calculated according to the CMH test adjusted for strata (Baseline FG score [< 8, ≥ 8], and baseline normal/obese status [BMI < 30, ≥ 30]) for the comparison of between each elagolix group and placebo. If zero frequency occurred, the zero count was replaced by 0.1 to prevent dividing by zero.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.914
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Response Rate Difference
Estimated Value -0.8
Confidence Interval (2-Sided) 90%
-13.10 to 11.48
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Area Under the Luteinizing Hormone (LH) Serum Concentration-time Curve (AUC) at Week 1
Hide Description [Not Specified]
Time Frame Week 0 (Baseline), Week 1: before the morning dose (0 hour) and at 0.5 (± 5 minutes), 1 (± 5 minutes), 1.5 (± 5 minutes), 2 (± 15 minutes), 2.5 (± 15 minutes), 3 (± 15 minutes), 3.5 (± 15 minutes), and 4 (± 15 minutes) hours after dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all randomly assigned participants who have received at least one dose of study drug in this study. Participants with an assessment.
Arm/Group Title Placebo Elagolix 25 mg BID Elagolix 50 mg QD Elagolix 75 mg BID Elagolix 150 mg QD Elagolix 300 mg QD
Hide Arm/Group Description:
Placebo taken orally BID
Elagolix 25 mg taken orally BID plus placebo
Elagolix 50 mg taken orally QD plus placebo
Elagolix 75 mg taken orally BID plus placebo
Elagolix 150 mg taken orally QD plus placebo
Elagolix 300 mg taken orally QD plus placebo
Overall Number of Participants Analyzed 24 15 15 16 13 15
Least Squares Mean (Standard Error)
Unit of Measure: (IU/L)*hr
-1.82  (2.292) -7.75  (2.867) -10.65  (2.861) -17.92  (2.692) -7.97  (3.112) -13.54  (2.763)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 25 mg BID
Comments P-value is from mixed-effect model repeated measure (MMRM) with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.087
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares (LS) Mean of Difference
Estimated Value -5.93
Confidence Interval (2-Sided) 90%
-11.628 to -0.231
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.429
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 50 mg QD
Comments P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -8.83
Confidence Interval (2-Sided) 90%
-14.533 to -3.118
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.435
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 75 mg BID
Comments P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -16.10
Confidence Interval (2-Sided) 90%
-21.673 to -10.519
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.356
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 150 mg QD
Comments P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -6.15
Confidence Interval (2-Sided) 90%
-12.116 to -0.176
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.593
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Elagolix 300 mg QD
Comments P-value is from MMRM with the fixed categorical effects of treatment, visit, treatment-by-visit interaction, baseline FG score (< 8, ≥ 8), and baseline normal/obese status (BMI < 30, ≥ 30), participant as a random effect, and the continuous fixed covariate of baseline measurement. Model is based on unstructured variance covariance structure.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean of Difference
Estimated Value -11.72
Confidence Interval (2-Sided) 90%
-17.418 to -6.016
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.431
Estimation Comments [Not Specified]
Time Frame From first dose of study drug through the end of treatment plus 30 days. Overall mean duration of treatment was 105.8 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Elagolix 25 mg BID Elagolix 50 mg QD Elagolix 75 mg BID Elagolix 150 mg QD Elagolix 300 mg QD
Hide Arm/Group Description Placebo taken orally BID Elagolix 25 mg taken orally BID plus placebo Elagolix 50 mg taken orally QD plus placebo Elagolix 75 mg taken orally BID plus placebo Elagolix 150 mg taken orally QD plus placebo Elagolix 300 mg taken orally QD plus placebo
All-Cause Mortality
Placebo Elagolix 25 mg BID Elagolix 50 mg QD Elagolix 75 mg BID Elagolix 150 mg QD Elagolix 300 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)      0/18 (0.00%)      0/17 (0.00%)      0/17 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Hide Serious Adverse Events
Placebo Elagolix 25 mg BID Elagolix 50 mg QD Elagolix 75 mg BID Elagolix 150 mg QD Elagolix 300 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      1/18 (5.56%)      0/17 (0.00%)      0/17 (0.00%)      0/18 (0.00%)      0/18 (0.00%)    
Hepatobiliary disorders             
CHOLECYSTITIS CHRONIC  1  0/26 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
1
Term from vocabulary, MedDRA 23.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Elagolix 25 mg BID Elagolix 50 mg QD Elagolix 75 mg BID Elagolix 150 mg QD Elagolix 300 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/26 (38.46%)      9/18 (50.00%)      8/17 (47.06%)      6/17 (35.29%)      11/18 (61.11%)      10/18 (55.56%)    
Blood and lymphatic system disorders             
ANAEMIA  1  0/26 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 2/18 (11.11%)  2 0/18 (0.00%)  0
Endocrine disorders             
HYPERANDROGENISM  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Eye disorders             
VISUAL IMPAIRMENT  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Gastrointestinal disorders             
ABDOMINAL PAIN LOWER  1  1/26 (3.85%)  1 1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
DIARRHOEA  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
FOOD POISONING  1  0/26 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
NAUSEA  1  3/26 (11.54%)  3 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
SALIVARY GLAND CYST  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
VOMITING  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
General disorders             
FATIGUE  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
PYREXIA  1  1/26 (3.85%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations             
COVID-19  1  1/26 (3.85%)  1 1/18 (5.56%)  1 1/17 (5.88%)  1 0/17 (0.00%)  0 2/18 (11.11%)  2 1/18 (5.56%)  1
CELLULITIS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
CHRONIC TONSILLITIS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
EAR INFECTION  1  0/26 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
FOLLICULITIS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
GASTROENTERITIS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
GASTROENTERITIS VIRAL  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
NASOPHARYNGITIS  1  1/26 (3.85%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
ORAL BACTERIAL INFECTION  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
PILONIDAL CYST  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
SCHISTOSOMIASIS CUTANEOUS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
URINARY TRACT INFECTION  1  1/26 (3.85%)  1 1/18 (5.56%)  1 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 2/18 (11.11%)  2
VULVOVAGINAL CANDIDIASIS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Injury, poisoning and procedural complications             
CONTUSION  1  0/26 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
NAIL AVULSION  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Investigations             
BLOOD GLUCOSE INCREASED  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
BLOOD INSULIN INCREASED  1  0/26 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 1/17 (5.88%)  1 1/18 (5.56%)  1 1/18 (5.56%)  1
BLOOD TRIGLYCERIDES INCREASED  1  1/26 (3.85%)  1 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
BONE DENSITY DECREASED  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
LIPIDS INCREASED  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
LIVER FUNCTION TEST INCREASED  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
WEIGHT INCREASED  1  0/26 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
Metabolism and nutrition disorders             
DECREASED APPETITE  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
DYSLIPIDAEMIA  1  0/26 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
HYPERGLYCAEMIA  1  0/26 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
HYPERTRIGLYCERIDAEMIA  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
VITAMIN D DEFICIENCY  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders             
ARTHRALGIA  1  2/26 (7.69%)  2 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
BACK PAIN  1  0/26 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
MYALGIA  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders             
HEADACHE  1  1/26 (3.85%)  1 1/18 (5.56%)  1 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Psychiatric disorders             
ATTENTION DEFICIT HYPERACTIVITY DISORDER  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
DEPRESSION  1  1/26 (3.85%)  1 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
INSOMNIA  1  0/26 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 1/17 (5.88%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0
MOOD SWINGS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
STRESS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Renal and urinary disorders             
NEPHROLITHIASIS  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Reproductive system and breast disorders             
AMENORRHOEA  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
CERVICAL DYSPLASIA  1  0/26 (0.00%)  0 1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
DYSFUNCTIONAL UTERINE BLEEDING  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
MENORRHAGIA  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
PELVIC DISCOMFORT  1  0/26 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
PREMENSTRUAL SYNDROME  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
ADENOIDAL HYPERTROPHY  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
ASTHMA  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
TONSILLAR HYPERTROPHY  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders             
DERMATITIS CONTACT  1  0/26 (0.00%)  0 0/18 (0.00%)  0 1/17 (5.88%)  2 0/17 (0.00%)  0 0/18 (0.00%)  0 0/18 (0.00%)  0
SKIN IRRITATION  1  0/26 (0.00%)  0 0/18 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Vascular disorders             
HOT FLUSH  1  2/26 (7.69%)  2 1/18 (5.56%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
1
Term from vocabulary, MedDRA 23.1
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
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie
Phone: 800-633-9110
EMail: abbvieclinicaltrials@abbvie.com
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03951077    
Other Study ID Numbers: M16-837
First Submitted: May 6, 2019
First Posted: May 15, 2019
Results First Submitted: May 16, 2022
Results First Posted: June 8, 2022
Last Update Posted: June 8, 2022