Safety and Efficacy in Premenopausal Women With Heavy Men... | NCT01817530 | Trialant
NCT01817530
Sponsor
AbbVie
Status
Completed
Last Update Posted
Jul 21, 2020Actual
Enrollment
571Actual
Phase
Phase 2
Conditions
Heavy Uterine Bleeding
Uterine Fibroids
Interventions
Elagolix placebo
Elagolix
0.5 mg estradiol / 0.1 mg norethindrone acetate
1 mg estradiol / 0.5 mg norethindrone acetate
E2/NETA placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01817530
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M12-813
Secondary IDs
ID
Type
Description
Link
2013-000082-37
EudraCT Number
Brief Title
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Official Title
A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 8, 2013Actual
Primary Completion Date
Jun 2015Actual
Completion Date
Dec 2015Actual
First Submitted Date
Mar 21, 2013
First Submission Date that Met QC Criteria
Mar 21, 2013
First Posted Date
Mar 25, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 9, 2020
Results First Submitted that Met QC Criteria
Jul 7, 2020
Results First Posted Date
Jul 21, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 15, 2016
Certification/Extension First Submitted that Passed QC Review
Jun 15, 2016
Certification/Extension First Posted Date
Jun 16, 2016Estimated
Last Update Submitted Date
Jul 7, 2020
Last Update Posted Date
Jul 21, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
Detailed Description
Not provided
Conditions Module
Conditions
Heavy Uterine Bleeding
Uterine Fibroids
Keywords
Uterine Fibroids
Leiomyomata
Elagolix
Menorrhagia
Elagolix sodium
Heavy Uterine Bleeding
ABT-620
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
571Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Placebo
Placebo Comparator
Placebo for elagolix and placebo for E2/NETA twice daily (BID)
Other: Elagolix placebo
Drug: E2/NETA placebo
Cohort 1: Elagolix 300 mg BID
Experimental
Elagolix 300 mg BID alone
Drug: Elagolix
Drug: E2/NETA placebo
Cohort 1: Elagolix 300 mg BID plus LD E2/NETA QD
Experimental
Elagolix 300 mg BID plus low-dose (LD) E2/NETA once daily (QD)
Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of < 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Baseline, Final Month (last 28 days of treatment)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject is pre-menopausal female 18 to 51 years of age at Screening.
Subject has diagnosis of uterine fibroids documented by a Pelvic Ultrasound.
Subject has heavy uterine bleeding associated with uterine fibroids.
Exclusion Criteria:
Subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to Screening or endometrial ablation within 5 years prior to Screening.
Subject has a history of osteoporosis or other metabolic bone disease.
Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. Subject has any history of attempted suicide.
Subject has a history of clinically significant condition(s) including but not limited to: * Symptomatic Endometriosis * Epilepsy or seizures * Type 1 diabetes * Chronic kidney disease * Any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Carr BR, Stewart EA, Archer DF, Al-Hendy A, Bradley L, Watts NB, Diamond MP, Gao J, Owens CD, Chwalisz K, Duan WR, Soliman AM, Dufek MB, Simon JA. Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled Trial. Obstet Gynecol. 2018 Nov;132(5):1252-1264. doi: 10.1097/AOG.0000000000002933.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Four participants were randomized in error; they were not dosed and were excluded from all analyses including demographic summaries.
Recruitment Details
Overall, 571 female participants were enrolled into the study across 86 sites (5 sites in the UK, 4 in Chile, 2 in Canada, 4 in Puerto Rico, and 71 in the US).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Placebo
Placebo for elagolix twice daily (BID) and placebo for E2/NETA once daily (QD)
Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)
Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month
Percentage of participants who achieved an MBL volume of < 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Final Month (last 28 days of treatment)
Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
Percentage of participants with a >= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Baseline, Final Month (last 28 days of treatment)
Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment
Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment.
Last 56 days of treatment (after 10 days from first dose date)
Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment
Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment.
Last 56 days of treatment (after 10 days from first dose date)
Mean Change in the Number of Bleeding Days From Baseline to Month 6
The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
Baseline, Month 6
Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6
The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
Baseline, Month 6
Change in Bleeding Severity Scores From Baseline at the Final Month
The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug.
Baseline, Final Month (last 28 days of treatment)
Mean Change in Hemoglobin Concentration From Baseline to Final Visit
Baseline is defined as the last measurement prior to the first dose of study drug.
Baseline, Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound.
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound.
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound.
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound.
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound.
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound.
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug.
Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168
Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids
The percentage of participants who successfully avoided surgical or invasive procedures for Uterine Fibroids was assessed.
Month 6
FG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus low-dose (LD) E2/NETA QD
FG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
FG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
FG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
FG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
FG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
FG00065 subjects
FG00165 subjects
FG00264 subjects
FG00365 subjects
FG00478 subjects
FG00577 subjects
FG00676 subjects
FG00777 subjects
COMPLETED
FG00050 subjects
FG00152 subjects
FG00253 subjects
FG00352 subjects
FG00467 subjects
FG00558 subjects
FG00653 subjects
FG00753 subjects
NOT COMPLETED
FG00015 subjects
FG00113 subjects
FG00211 subjects
FG00313 subjects
FG00411 subjects
FG00519 subjects
FG00623 subjects
FG00724 subjects
Type
Comment
Reasons
Exclusionary Medication Received
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Adverse Event
FG0006 subjects
FG0013 subjects
FG0022 subjects
FG0035 subjects
FG004
Subject Noncompliant
FG0003 subjects
FG0011 subjects
FG0020 subjects
FG0034 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Surgery or Invasive Intervention
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Consent Withdrawn by Subject
FG0003 subjects
FG0014 subjects
FG0027 subjects
FG0033 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0014 subjects
FG0022 subjects
FG0031 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
BG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
BG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
BG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
BG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
BG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
BG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
BG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00065
BG00165
BG00264
BG00365
BG00478
BG00577
BG00676
BG00777
BG008567
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00042.5± 6.14
BG00142.0± 4.76
BG00243.0± 5.02
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00065
BG00165
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of < 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Modified Intent-to-Treat (ITT): randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with < 28 days of treatment.
Posted
Number
percentage of participants
Baseline, Final Month (last 28 days of treatment)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00064
OG00162
OG00261
OG003
Title
Denominators
Categories
Title
Measurements
OG00026.56
OG00191.94
OG00285.25
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
32.51
2-Sided
95
11.12
95.05
Superiority
OG000
OG001
Secondary
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with < 56 days of treatment.
Posted
Number
percentage of participants
Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Secondary
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with < 84 days of treatment.
Posted
Number
percentage of participants
Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Secondary
Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month
Percentage of participants who achieved an MBL volume of < 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with < 28 days of treatment.
Posted
Number
percentage of participants
Final Month (last 28 days of treatment)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
Percentage of participants with a >= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with < 28 days of treatment.
Posted
Number
percentage of participants
Baseline, Final Month (last 28 days of treatment)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment
Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with < 66 days of treatment.
Posted
Number
percentage of participants
Last 56 days of treatment (after 10 days from first dose date)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Secondary
Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment
Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with < 66 days of treatment.
Posted
Number
percentage of participants
Last 56 days of treatment (after 10 days from first dose date)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Secondary
Mean Change in the Number of Bleeding Days From Baseline to Month 6
The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and Month 6.
Posted
Least Squares Mean
Standard Error
days
Baseline, Month 6
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6
The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and Month 6.
Posted
Least Squares Mean
Standard Error
days
Baseline, Month 6
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Change in Bleeding Severity Scores From Baseline at the Final Month
The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and final month.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Final Month (last 28 days of treatment)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Secondary
Mean Change in Hemoglobin Concentration From Baseline to Final Visit
Baseline is defined as the last measurement prior to the first dose of study drug.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and final month.
Posted
Least Squares Mean
Standard Error
g/dL
Baseline, Final Visit during treatment period (Month 6 or early termination)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and final month.
Posted
Mean
Standard Deviation
percentage change
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Posted
Mean
Standard Deviation
percentage change
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Posted
Mean
Standard Deviation
percentage change
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Posted
Number
percentage of participants
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Posted
Number
percentage of participants
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Posted
Number
percentage of participants
Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
Secondary
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug.
Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Secondary
Percentage of Participants Who Successfully Avoided Surgical or Invasive Procedures for Uterine Fibroids
The percentage of participants who successfully avoided surgical or invasive procedures for Uterine Fibroids was assessed.
This endpoint was not completed due to lack of data collection.
Posted
Month 6
ID
Title
Description
OG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
OG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
OG004
Cohort 2: Placebo
Time Frame
From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: Placebo
Placebo for elagolix BID and placebo for E2/NETA QD
0
65
6
65
33
65
EG001
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
0
65
3
65
45
65
EG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
0
64
3
64
37
64
EG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
0
65
1
65
44
65
EG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
0
78
1
78
42
78
EG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
0
77
5
77
59
77
EG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
0
76
3
76
43
76
EG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
0
77
4
77
51
77
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG0031 events1 affected65 at risk
EG0041 events1 affected78 at risk
EG0051 events1 affected77 at risk
EG0060 events0 affected76 at risk
EG0071 events1 affected77 at risk
IRON DEFICIENCY ANAEMIA
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
CORONARY ARTERY DISEASE
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
DIVERTICULAR PERFORATION
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
APPENDICITIS
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
VARICELLA
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
CONCUSSION
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
MENISCUS INJURY
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
ROAD TRAFFIC ACCIDENT
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
BREAST CANCER
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
ENDOMETRIAL ADENOCARCINOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
GASTRINOMA MALIGNANT
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
UTERINE LEIOMYOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
SYNCOPE
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
CYSTOCELE
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
UTERINE HAEMORRHAGE
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
PULMONARY EMBOLISM
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
DEEP VEIN THROMBOSIS
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0006 events6 affected65 at risk
EG0011 events1 affected65 at risk
EG0022 events2 affected64 at risk
EG0032 events2 affected65 at risk
EG0046 events6 affected78 at risk
EG0053 events3 affected77 at risk
EG0066 events6 affected76 at risk
EG0074 events4 affected77 at risk
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 events2 affected65 at risk
EG0011 events1 affected65 at risk
EG0022 events2 affected64 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0014 events4 affected65 at risk
EG0020 events0 affected64 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0024 events1 affected64 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0003 events3 affected65 at risk
EG0011 events1 affected65 at risk
EG0022 events2 affected64 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0006 events6 affected65 at risk
EG0014 events4 affected65 at risk
EG0024 events4 affected64 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 events1 affected65 at risk
EG0011 events1 affected65 at risk
EG0020 events0 affected64 at risk
EG003
FATIGUE
General disorders
MedDRA (18.1)
Systematic Assessment
EG0002 events2 affected65 at risk
EG0013 events3 affected65 at risk
EG0024 events4 affected64 at risk
EG003
BACTERIAL VAGINOSIS
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0004 events4 affected65 at risk
EG0016 events4 affected65 at risk
EG0025 events4 affected64 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0004 events4 affected65 at risk
EG0013 events3 affected65 at risk
EG0024 events4 affected64 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0012 events2 affected65 at risk
EG0022 events2 affected64 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0002 events1 affected65 at risk
EG0013 events3 affected65 at risk
EG0021 events1 affected64 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0002 events2 affected65 at risk
EG0013 events2 affected65 at risk
EG0027 events5 affected64 at risk
EG003
VULVOVAGINAL MYCOTIC INFECTION
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected65 at risk
EG0023 events2 affected64 at risk
EG003
BLOOD CHOLESTEROL INCREASED
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
BONE DENSITY DECREASED
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0015 events5 affected65 at risk
EG0022 events2 affected64 at risk
EG003
LIPIDS INCREASED
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0010 events0 affected65 at risk
EG0020 events0 affected64 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0011 events1 affected65 at risk
EG0021 events1 affected64 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0003 events3 affected65 at risk
EG0016 events3 affected65 at risk
EG0023 events3 affected64 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0006 events6 affected65 at risk
EG0015 events5 affected65 at risk
EG0022 events2 affected64 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0002 events2 affected65 at risk
EG0010 events0 affected65 at risk
EG0021 events1 affected64 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0014 events4 affected65 at risk
EG0021 events1 affected64 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0002 events2 affected65 at risk
EG0014 events4 affected65 at risk
EG0022 events2 affected64 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0003 events3 affected65 at risk
EG0013 events3 affected65 at risk
EG0021 events1 affected64 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0007 events6 affected65 at risk
EG0018 events8 affected65 at risk
EG0029 events9 affected64 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0017 events7 affected65 at risk
EG0025 events5 affected64 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0002 events2 affected65 at risk
EG0012 events2 affected65 at risk
EG0021 events1 affected64 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0001 events1 affected65 at risk
EG0012 events2 affected65 at risk
EG0023 events3 affected64 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0000 events0 affected65 at risk
EG0012 events2 affected65 at risk
EG0021 events1 affected64 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0002 events2 affected65 at risk
EG00132 events29 affected65 at risk
EG00216 events16 affected64 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0003 events3 affected65 at risk
EG0011 events1 affected65 at risk
EG0021 events1 affected64 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Global Medical Services
AbbVie
800-633-9110
abbvieclinicaltrials@abbvie.com
ID
Term
D007889
Leiomyoma
D008595
Menorrhagia
Ancestor Terms
ID
Term
D009379
Neoplasms, Muscle Tissue
D018204
Neoplasms, Connective and Soft Tissue
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D014592
Uterine Hemorrhage
D014591
Uterine Diseases
D005831
Genital Diseases, Female
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D000091662
Genital Diseases
D006470
Hemorrhage
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
D008599
Menstruation Disturbances
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C539351
elagolix
D004958
Estradiol
D000077563
Norethindrone Acetate
C418365
estradiol, norethindrone drug combination
Ancestor Terms
ID
Term
D004963
Estrenes
D004962
Estranes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D045166
Estradiol Congeners
D012739
Gonadal Steroid Hormones
D042341
Gonadal Hormones
D006728
Hormones
D006730
Hormones, Hormone Substitutes, and Hormone Antagonists
D009640
Norethindrone
D009652
Norpregnenes
D009650
Norpregnanes
D009654
Norsteroids
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG00510 subjects
FG0065 subjects
FG0078 subjects
0 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0071 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0050 subjects
FG0065 subjects
FG0070 subjects
1 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
5 subjects
FG0053 subjects
FG0063 subjects
FG00710 subjects
3 subjects
FG0052 subjects
FG0068 subjects
FG0074 subjects
43.8
± 4.66
BG00442.3± 4.78
BG00542.1± 4.93
BG00641.1± 5.74
BG00742.2± 5.40
BG00842.3± 5.22
64
BG00365
BG00478
BG00577
BG00676
BG00777
BG008567
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
62
OG00476
OG00571
OG00673
OG00776
79.03
OG00431.58
OG00590.14
OG00672.6
OG00781.58
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG002
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
16.66
2-Sided
95
6.72
41.3
Superiority
OG000
OG002
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG003
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
11.13
2-Sided
95
4.79
25.84
Superiority
OG000
OG003
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG005
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
19.62
2-Sided
95
7.81
49.27
Superiority
OG004
OG005
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG006
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
6.02
2-Sided
95
2.95
12.3
Superiority
OG004
OG006
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG007
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
10.34
2-Sided
95
4.79
22.34
Superiority
OG004
OG007
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
Elagolix 300 mg BID plus SD E2/NETA QD
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00062
OG00158
OG00259
OG00360
OG00476
OG00568
OG00664
OG00770
Title
Denominators
Categories
Title
Measurements
OG00011.29
OG00194.83
OG00288.14
OG00385.00
OG00418.42
OG00585.29
OG00667.19
OG00777.14
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
156.17
2-Sided
95
38.04
641.22
Superiority
OG000
OG001
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG002
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
66.07
2-Sided
95
21.1
206.88
Superiority
OG000
OG002
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG003
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
52.15
2-Sided
95
17.42
156.09
Superiority
OG000
OG003
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG005
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
25.45
2-Sided
95
10.45
61.96
Superiority
OG004
OG005
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG006
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
9.65
2-Sided
95
4.38
21.25
Superiority
OG004
OG006
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG007
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
16.17
2-Sided
95
7.13
36.67
Superiority
OG004
OG007
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
Elagolix 300 mg BID plus SD E2/NETA QD
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00061
OG00156
OG00257
OG00358
OG00474
OG00566
OG00662
OG00765
Title
Denominators
Categories
Title
Measurements
OG00019.67
OG00196.43
OG00289.47
OG00379.31
OG00421.62
OG00586.36
OG00674.19
OG00772.31
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
123.14
2-Sided
95
25.93
584.85
Superiority
OG000
OG001
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG002
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
40.56
2-Sided
95
13.59
121.03
Superiority
OG000
OG002
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG003
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
19.01
2-Sided
95
7.44
48.58
Superiority
OG000
OG003
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG005
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
22.77
2-Sided
95
9.29
55.77
Superiority
OG004
OG005
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG006
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
10.89
2-Sided
95
4.88
24.27
Superiority
OG004
OG006
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG007
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline as a covariate.
Odds Ratio (OR)
9.72
2-Sided
95
4.46
21.22
Superiority
OG004
OG007
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00064
OG00162
OG00261
OG00362
OG00476
OG00571
OG00673
OG00776
Title
Denominators
Categories
Title
Measurements
OG00032.81
OG00191.94
OG00288.52
OG00379.03
OG00436.84
OG00591.55
OG00672.6
OG00785.53
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
24.73
2-Sided
95
8.57
71.32
Superiority
OG000
OG001
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG002
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
17.21
2-Sided
95
6.57
45.05
Superiority
OG000
OG002
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG003
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
8.69
2-Sided
95
3.79
19.92
Superiority
OG000
OG003
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG005
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
18.67
2-Sided
95
7.11
49.02
Superiority
OG004
OG005
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG006
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
4.94
2-Sided
95
2.43
10.04
Superiority
OG004
OG006
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG007
Regression, Logistic
P value is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
< 0.001
Odds Ratio (OR)
11.76
2-Sided
95
5.17
26.79
Superiority
OG004
OG007
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00064
OG00162
OG00261
OG00362
OG00476
OG00571
OG00673
OG00776
Title
Denominators
Categories
Title
Measurements
OG00031.25
OG00193.55
OG00286.89
OG00382.26
OG00435.53
OG00590.14
OG00679.45
OG00785.53
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
31.48
2-Sided
95
10.02
98.83
Superiority
OG000
OG001
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG002
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
14.39
2-Sided
95
5.77
35.91
Superiority
OG000
OG002
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG000
OG003
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
9.82
2-Sided
95
4.23
22.8
Superiority
OG000
OG003
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG005
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
16.58
2-Sided
95
6.66
41.26
Superiority
OG004
OG005
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG006
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
7.02
2-Sided
95
3.36
14.68
Superiority
OG004
OG006
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
OG004
OG007
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Odds Ratio (OR)
10.73
2-Sided
95
4.85
23.76
Superiority
OG004
OG007
Chi-squared
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a chi-square test.
Superiority
Elagolix 300 mg BID plus SD E2/NETA QD
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00061
OG00157
OG00257
OG00360
OG00475
OG00567
OG00663
OG00766
Title
Denominators
Categories
Title
Measurements
OG0001.6
OG00156.1
OG00233.3
OG00328.3
OG0041.3
OG00550.7
OG00617.5
OG00722.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
< 0.001
Superiority
OG000
OG002
Fisher Exact
< 0.001
Superiority
OG000
OG003
Fisher Exact
< 0.001
Superiority
OG004
OG005
Fisher Exact
< 0.001
Superiority
OG004
OG006
Fisher Exact
< 0.001
Superiority
OG004
OG007
Fisher Exact
< 0.001
Superiority
Elagolix 300 mg BID plus SD E2/NETA QD
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00061
OG00157
OG00257
OG00360
OG00475
OG00567
OG00663
OG00766
Title
Denominators
Categories
Title
Measurements
OG0001.6
OG00175.4
OG00252.6
OG00343.3
OG0042.7
OG00567.2
OG00631.7
OG00734.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
< 0.001
Superiority
OG000
OG002
Fisher Exact
< 0.001
Superiority
OG000
OG003
Fisher Exact
< 0.001
Superiority
OG004
OG005
Fisher Exact
< 0.001
Superiority
OG004
OG006
Fisher Exact
< 0.001
Superiority
OG004
OG007
Fisher Exact
< 0.001
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00037
OG00111
OG00226
OG00330
OG00447
OG00515
OG00626
OG00728
Title
Denominators
Categories
Title
Measurements
OG000-1.2± 0.63
OG001-4.9± 1.15
OG002-2.7± 0.75
OG003-1.1± 0.69
OG004-1.4± 0.49
OG005-3.3± 0.87
OG006-1.3± 0.66
OG007-1.8± 0.64
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.007
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-3.7
Standard Error of the Mean
1.32
2-Sided
95
-6.28
-1.03
Superiority
OG000
OG002
ANCOVA
0.132
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-1.5
Standard Error of the Mean
0.98
2-Sided
95
-3.44
0.46
Superiority
OG000
OG003
ANCOVA
0.876
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
0.1
Standard Error of the Mean
0.94
2-Sided
95
-1.71
2.00
Superiority
OG004
OG005
ANCOVA
0.055
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-1.9
Standard Error of the Mean
1.00
2-Sided
95
-3.92
0.04
Superiority
OG004
OG006
ANCOVA
0.898
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
0.1
Standard Error of the Mean
0.82
2-Sided
95
-1.52
1.74
Superiority
OG004
OG007
ANCOVA
0.59
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-0.4
Standard Error of the Mean
0.81
2-Sided
95
-2.05
1.17
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00037
OG00111
OG00226
OG00330
OG00447
OG00515
OG00626
OG00728
Title
Denominators
Categories
Title
Measurements
OG000-1.0± 0.15
OG001-2.0± 0.27
OG002-1.9± 0.18
OG003-1.7± 0.16
OG004-0.7± 0.14
OG005-1.2± 0.25
OG006-1.4± 0.19
OG007-1.8± 0.18
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-1.00
Standard Error of the Mean
0.31
2-Sided
95
-1.64
-0.42
Superiority
OG000
OG002
ANCOVA
< 0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-1.00
Standard Error of the Mean
0.23
2-Sided
95
-1.42
-0.48
Superiority
OG000
OG003
ANCOVA
0.002
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-0.7
Standard Error of the Mean
0.22
2-Sided
95
-1.12
-0.25
Superiority
OG004
OG005
ANCOVA
0.118
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-0.5
Standard Error of the Mean
0.29
2-Sided
95
-1.04
0.12
Superiority
OG004
OG006
ANCOVA
0.004
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-0.7
Standard Error of the Mean
0.24
2-Sided
95
-1.16
-0.22
Superiority
OG004
OG007
ANCOVA
< 0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS mean change
-1.00
Standard Error of the Mean
0.23
2-Sided
95
-1.51
-0.59
Superiority
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00051
OG00119
OG00233
OG00337
OG00461
OG00524
OG00648
OG00742
Title
Denominators
Categories
Title
Measurements
OG000-0.3± 0.08
OG001-0.7± 0.14
OG002-0.4± 0.10
OG003-0.1± 0.10
OG004-0.2± 0.08
OG005-0.4± 0.14
OG006-0.3± 0.10
OG007-0.1± 0.10
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.004
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.
difference in LS mean change
-0.5
Standard Error of the Mean
0.16
2-Sided
95
-0.79
-0.15
Superiority
OG000
OG002
ANCOVA
0.314
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.
difference in LS mean change
-0.1
Standard Error of the Mean
0.13
2-Sided
95
-0.4
0.13
Superiority
OG000
OG003
ANCOVA
0.307
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.
difference in LS mean change
0.1
Standard Error of the Mean
0.13
2-Sided
95
-0.12
0.39
Superiority
OG004
OG005
ANCOVA
0.106
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.
difference in LS mean change
-0.3
Standard Error of the Mean
0.16
2-Sided
95
-0.58
0.06
Superiority
OG004
OG006
ANCOVA
0.424
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.
difference in LS mean change
-0.1
Standard Error of the Mean
0.13
2-Sided
95
-0.36
0.15
Superiority
OG004
OG007
ANCOVA
0.528
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from an ANCOVA model with treatment as the main effect and baseline as a covariate.
difference in LS mean change
0.1
Standard Error of the Mean
0.13
2-Sided
95
-0.18
0.35
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00064
OG00161
OG00259
OG00361
OG00476
OG00571
OG00672
OG00774
Title
Denominators
Categories
Title
Measurements
OG0000.6± 0.17
OG0011.9± 0.17
OG0021.9± 0.17
OG0031.4± 0.17
OG0040.3± 0.15
OG0051.4± 0.16
OG0061.1± 0.16
OG0071.2± 0.16
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
< 0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS means
1.3
Standard Error of the Mean
0.24
2-Sided
95
0.80
1.74
Superiority
OG000
OG002
ANCOVA
< 0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS means
1.3
Standard Error of the Mean
0.24
2-Sided
95
0.78
1.72
Superiority
OG000
OG003
ANCOVA
< 0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS means
0.8
Standard Error of the Mean
0.24
2-Sided
95
0.33
1.27
Superiority
OG004
OG005
ANCOVA
< 0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS means
1.1
Standard Error of the Mean
0.22
2-Sided
95
0.65
1.52
Superiority
OG004
OG006
ANCOVA
< 0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS means
0.7
Standard Error of the Mean
0.22
2-Sided
95
0.29
1.16
Superiority
OG004
OG007
ANCOVA
< 0.001
P value for test of difference between each elagolix dose group and placebo at each postbaseline time point is from an ANCOVA model with treatment as the main effect and baseline value as a covariate.
difference in LS means
0.8
Standard Error of the Mean
0.22
2-Sided
95
0.4
1.26
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00065
OG00165
OG00264
OG00365
OG00478
OG00577
OG00676
OG00777
Title
Denominators
Categories
Month 3
ParticipantsOG00053
ParticipantsOG00149
ParticipantsOG00252
ParticipantsOG00347
ParticipantsOG00464
ParticipantsOG00557
ParticipantsOG00653
ParticipantsOG00758
Title
Measurements
OG0001.7± 33.61
OG001-41.9± 24.87
OG002-24.6± 27.58
OG003
Month 6
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00248
ParticipantsOG00342
Final Visit
ParticipantsOG00053
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00351
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Month 3
Kruskal-Wallis
0.018
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG007
Month 3
Kruskal-Wallis
0.021
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG001
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Month 6
Kruskal-Wallis
0.032
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Month 6
Kruskal-Wallis
0.007
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG007
Month 6
Kruskal-Wallis
0.495
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG001
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Final Visit
Kruskal-Wallis
0.015
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Final Visit
Kruskal-Wallis
0.002
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG007
Final Visit
Kruskal-Wallis
0.329
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00065
OG00165
OG00264
OG00365
OG00478
OG00577
OG00676
OG00777
Title
Denominators
Categories
Month 3
ParticipantsOG00053
ParticipantsOG00149
ParticipantsOG00252
ParticipantsOG00347
ParticipantsOG00464
ParticipantsOG00557
ParticipantsOG00653
ParticipantsOG00758
Title
Measurements
OG0006.9± 35.31
OG001-35.5± 26.32
OG002-20.3± 33.54
OG003
Month 6
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00248
ParticipantsOG00342
Final Visit
ParticipantsOG00053
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00351
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Month 3
Kruskal-Wallis
0.036
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG007
Kruskal-Wallis
0.040
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG001
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Month 6
Kruskal-Wallis
0.098
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Month 6
Kruskal-Wallis
0.014
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG007
Month 6
Kruskal-Wallis
0.409
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG001
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Final Visit
Kruskal-Wallis
0.094
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Final Visit
Kruskal-Wallis
0.002
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG007
Final Visit
Kruskal-Wallis
0.393
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00065
OG00165
OG00264
OG00365
OG00478
OG00577
OG00676
OG00777
Title
Denominators
Categories
Month 3
ParticipantsOG00058
ParticipantsOG00152
ParticipantsOG00256
ParticipantsOG00354
ParticipantsOG00472
ParticipantsOG00563
ParticipantsOG00657
ParticipantsOG00763
Title
Measurements
OG0007.3± 25.12
OG001-30.9± 28.87
OG002-19.4± 22.48
OG003
Month 6
ParticipantsOG00051
ParticipantsOG00147
ParticipantsOG00250
ParticipantsOG00347
Final Visit
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00356
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Month 3
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG001
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG007
Month 6
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG001
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG002
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG000
OG003
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG005
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG006
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
OG007
Final Visit
Kruskal-Wallis
< 0.001
P value for test of difference between each elagolix dose group and placebo is from Kruskal-Wallis analysis with treatment as the main effect.
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00065
OG00165
OG00264
OG00365
OG00478
OG00577
OG00676
OG00777
Title
Denominators
Categories
Month 3
ParticipantsOG00053
ParticipantsOG00149
ParticipantsOG00252
ParticipantsOG00347
ParticipantsOG00464
ParticipantsOG00557
ParticipantsOG00653
ParticipantsOG00758
Title
Measurements
OG00013.2
OG00179.6
OG00250.0
OG003
Month 6
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00248
ParticipantsOG00342
Final Visit
ParticipantsOG00053
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00351
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Month 3
Regression, Logistic
0.020
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Month 3
Regression, Logistic
0.002
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Month 3
Regression, Logistic
0.061
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG001
Month 6
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Month 6
Regression, Logistic
0.004
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Month 6
Regression, Logistic
0.085
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Month 6
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Month 6
Regression, Logistic
0.012
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Month 6
Regression, Logistic
0.049
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG001
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Final Visit
Regression, Logistic
0.056
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Final Visit
Regression, Logistic
0.005
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Final Visit
Regression, Logistic
0.088
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00065
OG00165
OG00264
OG00365
OG00478
OG00577
OG00676
OG00777
Title
Denominators
Categories
Month 3
ParticipantsOG00053
ParticipantsOG00149
ParticipantsOG00252
ParticipantsOG00347
ParticipantsOG00464
ParticipantsOG00557
ParticipantsOG00653
ParticipantsOG00758
Title
Measurements
OG00013.2
OG00167.3
OG00246.2
OG003
Month 6
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00248
ParticipantsOG00342
Final Visit
ParticipantsOG00053
ParticipantsOG00153
ParticipantsOG00254
ParticipantsOG00351
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Month 3
Regression, Logistic
0.188
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Month 3
Regression, Logistic
0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Month 3
Regression, Logistic
0.104
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG001
Month 6
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Month 6
Regression, Logistic
0.021
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Month 6
Regression, Logistic
0.859
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Month 6
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Month 6
Regression, Logistic
0.006
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Month 6
Regression, Logistic
0.015
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG001
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Final Visit
Regression, Logistic
0.007
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Final Visit
Regression, Logistic
0.722
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Final Visit
Regression, Logistic
0.032
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00065
OG00165
OG00264
OG00365
OG00478
OG00577
OG00676
OG00777
Title
Denominators
Categories
Month 3
ParticipantsOG00058
ParticipantsOG00152
ParticipantsOG00256
ParticipantsOG00354
ParticipantsOG00472
ParticipantsOG00563
ParticipantsOG00657
ParticipantsOG00763
Title
Measurements
OG0005.2
OG00173.1
OG00242.9
OG003
Month 6
ParticipantsOG00051
ParticipantsOG00147
ParticipantsOG00250
ParticipantsOG00347
Final Visit
ParticipantsOG00058
ParticipantsOG00156
ParticipantsOG00256
ParticipantsOG00356
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Month 3
Regression, Logistic
0.041
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Month 3
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Month 3
Regression, Logistic
0.008
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG001
Month 6
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Month 6
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Month 6
Regression, Logistic
0.003
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Month 6
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Month 6
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Month 6
Regression, Logistic
0.003
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG001
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG002
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG000
OG003
Final Visit
Regression, Logistic
0.004
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG005
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG006
Final Visit
Regression, Logistic
< 0.001
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
OG004
OG007
Final Visit
Regression, Logistic
0.002
P value for test of difference between each elagolix dose group and placebo is from a logistic regression model including treatment as the main effect and baseline value as a covariate.
Superiority
Elagolix 300 mg BID and placebo for E2/NETA QD
OG002
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus LD E2/NETA QD
OG003
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus SD E2/NETA QD
OG004
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
OG005
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
OG006
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
OG007
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
Units
Counts
Participants
OG00065
OG00165
OG00264
OG00365
OG00478
OG00577
OG00676
OG00777
Title
Denominators
Categories
Days 1-28
ParticipantsOG00037
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00334
ParticipantsOG00471
ParticipantsOG00574
ParticipantsOG00671
ParticipantsOG00767
Title
Measurements
OG000-3.3± 10.11
OG001-3.4± 8.21
OG002-3.1± 7.88
OG003
Days 29-56
ParticipantsOG00035
ParticipantsOG00134
ParticipantsOG00234
ParticipantsOG00328
Days 57-84
ParticipantsOG00034
ParticipantsOG00131
ParticipantsOG00234
ParticipantsOG00328
Days 85-112
ParticipantsOG00031
ParticipantsOG00131
ParticipantsOG00231
ParticipantsOG00328
Days 113-140
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00232
ParticipantsOG00328
Days 141-168
ParticipantsOG00026
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00327
Final Month
ParticipantsOG00037
ParticipantsOG00134
ParticipantsOG00233
ParticipantsOG00331
PT Days 1-28
ParticipantsOG00029
ParticipantsOG00130
ParticipantsOG00228
ParticipantsOG00327
PT Days 29-56
ParticipantsOG00028
ParticipantsOG00129
ParticipantsOG00230
ParticipantsOG00326
PT Days 57-84
ParticipantsOG00026
ParticipantsOG00127
ParticipantsOG00227
ParticipantsOG00324
PT Days 85-112
ParticipantsOG00012
ParticipantsOG00110
ParticipantsOG00210
ParticipantsOG00311
PT Days 113-140
ParticipantsOG0004
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0033
PT Days 141-168
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0021
ParticipantsOG0031
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Final Month
ANCOVA
0.556
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.
difference in LS means
-1.5
Standard Error of the Mean
2.58
2-Sided
95
-6.65
3.59
Superiority
OG000
OG002
Final Month
ANCOVA
0.672
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.
difference in LS means
-1.1
Standard Error of the Mean
2.63
2-Sided
95
-6.33
4.09
Superiority
OG000
OG003
Final Month
ANCOVA
0.274
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.
difference in LS means
3.0
Standard Error of the Mean
2.71
2-Sided
95
-2.39
8.36
Superiority
OG004
OG005
Final Month
ANCOVA
0.223
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.
difference in LS means
-2.0
Standard Error of the Mean
1.65
2-Sided
95
-5.26
1.23
Superiority
OG004
OG006
Final Month
ANCOVA
0.215
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.
difference in LS means
-2.1
Standard Error of the Mean
1.68
2-Sided
95
-5.38
1.22
Superiority
OG004
OG007
Final Month
ANCOVA
0.392
P value for test of difference between each elagolix dose group and placebo at each post-baseline time point is from ANCOVA model with treatment as the main effect and baseline as covariate.
difference in LS means
-1.4
Standard Error of the Mean
1.68
2-Sided
95
-4.75
1.87
Superiority
Placebo for elagolix QD and placebo for E2/NETA QD