Safety and Efficacy of Elagolix in Pre-Menopausal Women W... | NCT01441635 | Trialant
NCT01441635
Sponsor
AbbVie (prior sponsor, Abbott)
Status
Completed
Last Update Posted
Jul 13, 2021Actual
Enrollment
271Actual
Phase
Phase 2
Conditions
Heavy Uterine Bleeding
Uterine Fibroids
Interventions
Elagolix
Placebo
Estradiol/Norethindrone acetate (E2/NETA)
Estradiol
Progesterone
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01441635
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M12-663
Secondary IDs
Not provided
Brief Title
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Official Title
Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Jul 2021
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
Sep 8, 2011Actual
Primary Completion Date
Nov 2013Actual
Completion Date
May 17, 2014Actual
First Submitted Date
Sep 6, 2011
First Submission Date that Met QC Criteria
Sep 26, 2011
First Posted Date
Sep 28, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 9, 2020
Results First Submitted that Met QC Criteria
Jul 1, 2020
Results First Posted Date
Jul 15, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 25, 2014
Certification/Extension First Submitted that Passed QC Review
Nov 25, 2014
Certification/Extension First Posted Date
Dec 11, 2014Estimated
Last Update Submitted Date
Jul 9, 2021
Last Update Posted Date
Jul 13, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVie (prior sponsor, Abbott)INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.
Detailed Description
Not provided
Conditions Module
Conditions
Heavy Uterine Bleeding
Uterine Fibroids
Keywords
Uterine Fibroids
Heavy Uterine Bleeding
Elagolix
Menorrhagia
ABT-620
Leiomyomata
Elagolix sodium
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
271Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 4 Elagolix 400 mg QD
Experimental
Participants received elagolix 400 mg once a day (QD) for 3 months.
Drug: Elagolix
Cohort 4 Elagolix 100 mg BID
Experimental
Participants received elagolix 100 mg twice a day (BID) for 3 months.
Drug: Elagolix
Cohort 4 Placebo
Placebo Comparator
Participants received placebo to elagolix BID for 3 months.
Drug: Placebo
Cohort 1 Elagolix 200 mg BID
Experimental
Participants received elagolix 200 mg twice a day for 3 months.
Drug: Elagolix
Cohort 1 Placebo
Placebo Comparator
Participants received placebo to elagolix twice a day for 3 months.
Drug: Placebo
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Placebo Comparator
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Elagolix
Drug
Elagolix tablets
Cohort 1 Elagolix 200 mg BID
Cohort 2 Elagolix 300 mg BID
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Cohort 4 Elagolix 100 mg BID
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
Secondary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject is a pre-menopausal female 20 to 49 years of age.
Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:
At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
Subject has a history of regular menstrual cycles between 24 to 35 days.
Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.
Exclusion Criteria:
Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
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), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.
Subject has a history of clinically significant condition(s) including but not limited to:
Endometriosis
Epilepsy or seizures
Type 1 diabetes
Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Archer DF, Stewart EA, Jain RI, Feldman RA, Lukes AS, North JD, Soliman AM, Gao J, Ng JW, Chwalisz K. Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept study. Fertil Steril. 2017 Jul;108(1):152-160.e4. doi: 10.1016/j.fertnstert.2017.05.006. Epub 2017 Jun 1.
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.
Six cohorts of participants were enrolled, with 3 double-blind cohorts comparing elagolix with placebo, 2 open-label cohorts assessing add-back therapies, and 1 open-label cohort assessing the elagolix 600 mg QD dosing regimen.
Recruitment Details
Overall, 271 female participants were enrolled into the study across 45 sites in the United States.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
FG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
Participants received elagolix 600 mg once a day for 3 months.
Drug: Elagolix
Cohort 2 Elagolix 300 mg BID
Experimental
Participants received elagolix 300 mg twice a day for 3 months.
Drug: Elagolix
Cohort 2 Placebo
Experimental
Participants received placebo to elagolix BID for 3 months.
Drug: Placebo
Cohort 6 Elagolix 300 mg BID + CEP
Experimental
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Drug: Elagolix
Drug: Estradiol
Drug: Progesterone
Cohort 4 Elagolix 400 mg QD
Cohort 5 Elagolix 600 mg QD
Cohort 6 Elagolix 300 mg BID + CEP
ABT-620
Placebo
Drug
Matching placebo tablets
Cohort 1 Placebo
Cohort 2 Placebo
Cohort 4 Placebo
Estradiol/Norethindrone acetate (E2/NETA)
Drug
A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Activella®
Estradiol
Drug
1.0 mg micronized estradiol tablets administered once a day
Cohort 6 Elagolix 300 mg BID + CEP
Estrace®
Progesterone
Drug
Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle
Cohort 6 Elagolix 300 mg BID + CEP
Prometrium®
Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
Percentage of Participants With MBL < 80 mL and With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
Percentage of Participants With MBL < 80 mL During the Last 28 Days of Treatment
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
The last 28 days of treatment (approximately days 61 to 90)
Percentage of Participants With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3
The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories:
No change from baseline in hemoglobin
Decrease from baseline in hemoglobin ≥ -0.5 g/dL
Decrease from baseline in hemoglobin ≥ -1.0 g/dL
Increase from baseline in hemoglobin ≥ 0.5 g/dL
Increase from baseline in hemoglobin ≥ 1.0 g/dL
The above categories are not all mutually exclusive or exhaustive.
Baseline and Month 3
Change in Hemoglobin Concentration From Baseline to Month 3
Baseline and Month 3
Change From Baseline to Month 3 in Uterine Bleeding Score
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
A day with any uterine bleeding is defined as a days with a bleeding score ≥ 1.
Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
A day with moderate to very heavy bleeding is defined as a days with a bleeding score ≥ 3.
Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3
Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
Any bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3.
Month 3 (average bleeding score over days 61 to 90)
Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment
Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment.
Amenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment.
The last 56 days of treatment (approximately days 33 to 90)
Percent Change From Baseline to Month 3 in Uterine Volume
Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
Baseline and month 3
Percentage of Participants With ≥ 25% Reduction in Uterine Volume at Month 3 / Final Visit
Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.
Percent Change From Baseline to Month 3 in Volume of the Largest Fibroid
The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
Baseline and month 3
Percentage of Participants With ≥ 25% Reduction in Volume of Largest Fibroid at Month 3 / Final Visit
The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.
Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL)
The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components.
Lower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life.
Baseline and month 3
Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores
The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary.
Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90)
Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0
The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery).
SSIQ included the 2 following questions:
How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now?
How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now?
Baseline and month 3
Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0
The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery).
The PSIQ included the 2 following questions:
How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now?
How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now?
Baseline and month 3
Derived
Coyne KS, Soliman AM, Margolis MK, Thompson CL, Chwalisz K. Validation of the 4 week recall version of the Uterine Fibroid Symptom and Health-related Quality of Life (UFS-QOL) Questionnaire. Curr Med Res Opin. 2017 Feb;33(2):193-200. doi: 10.1080/03007995.2016.1248382. Epub 2016 Nov 18.
FG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
FG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
FG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
FG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
FG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
FG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
FG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
FG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
FG00032 subjects
FG00133 subjects
FG00216 subjects
FG00335 subjects
FG00418 subjects
FG00534 subjects
FG00630 subjects
FG00730 subjects
FG00816 subjects
FG00927 subjects
COMPLETED
FG00026 subjects
FG00127 subjects
FG00213 subjects
FG00328 subjects
FG00416 subjects
FG00529 subjects
FG00624 subjects
FG00726 subjects
FG00814 subjects
FG00925 subjects
NOT COMPLETED
FG0006 subjects
FG0016 subjects
FG0023 subjects
FG0037 subjects
FG0042 subjects
FG0055 subjects
FG0066 subjects
FG0074 subjects
FG0082 subjects
FG0092 subjects
Type
Comment
Reasons
Adverse Event
FG0004 subjects
FG0013 subjects
FG0021 subjects
FG0035 subjects
FG0041 subjects
FG0052 subjects
FG0062 subjects
FG0072 subjects
FG0081 subjects
FG0090 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Noncompliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Surgery or Invasive Intervention
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Received Exclusionary Medication
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
BG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
BG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
BG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
BG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
BG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
BG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
BG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
BG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
BG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG00133
BG00216
BG00335
BG00418
BG00534
BG00630
BG00730
BG00816
BG00927
BG010271
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
BG00040.8± 5.50
BG00142.1± 5.09
BG00241.1± 5.88
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
< 35 years
BG0007
BG0013
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00032
BG00133
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0018
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0005
BG00110
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
Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. Last observation carried forward (LOCF) imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.
Posted
Mean
Standard Deviation
mL
Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00031
OG00131
OG00215
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000213.70± 108.08
OG001269.36± 163.17
OG002321.73± 327.57
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
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
< 0.001
LS Mean Difference
-205.9
Standard Error of the Mean
45.10
2-Sided
95
-295.77
-116.01
Superiority
OG001
OG002
ANCOVA
Secondary
Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL)
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. Last observation carried forward (LOCF) imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the electronic diary.
Posted
Mean
Standard Deviation
percent change
Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Secondary
Percentage of Participants With MBL < 80 mL and With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.
Posted
Number
percentage of participants
Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Secondary
Percentage of Participants With MBL < 80 mL During the Last 28 Days of Treatment
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.
Posted
Number
percentage of participants
The last 28 days of treatment (approximately days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
Secondary
Percentage of Participants With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.
Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants, excluding participants with less than 28 days of treatment. LOCF imputation was used for participants with no MBL volume reported by alkaline hematin method but with light to heavy bleeding reported in the eDiary.
Posted
Number
percentage of participants
Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Secondary
Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3
The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories:
No change from baseline in hemoglobin
Decrease from baseline in hemoglobin ≥ -0.5 g/dL
Decrease from baseline in hemoglobin ≥ -1.0 g/dL
Increase from baseline in hemoglobin ≥ 0.5 g/dL
Increase from baseline in hemoglobin ≥ 1.0 g/dL
The above categories are not all mutually exclusive or exhaustive.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available hemoglobin data.
Posted
Number
percentage of participants
Baseline and Month 3
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Secondary
Change in Hemoglobin Concentration From Baseline to Month 3
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available hemoglobin data at baseline and month 3.
Posted
Mean
Standard Deviation
g/dL
Baseline and Month 3
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
Secondary
Change From Baseline to Month 3 in Uterine Bleeding Score
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.
Posted
Mean
Standard Deviation
units on a scale
Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
Secondary
Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
A day with any uterine bleeding is defined as a days with a bleeding score ≥ 1.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.
Posted
Mean
Standard Deviation
percentage of days
Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
Secondary
Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding
Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
A day with moderate to very heavy bleeding is defined as a days with a bleeding score ≥ 3.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at baseline and month 3.
Posted
Mean
Standard Deviation
percentage of days
Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
Secondary
Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3
Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
Any bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available bleeding score data at month 3.
Posted
Number
percentage of participants
Month 3 (average bleeding score over days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
Secondary
Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment
Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment.
Amenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants including participants with less than 56 days of treatment who bled but excluded those who did not bleed.
Posted
Number
percentage of participants
The last 56 days of treatment (approximately days 33 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
Secondary
Percent Change From Baseline to Month 3 in Uterine Volume
Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.
Posted
Mean
Standard Deviation
percent change
Baseline and month 3
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Secondary
Percentage of Participants With ≥ 25% Reduction in Uterine Volume at Month 3 / Final Visit
Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.
Posted
Number
percentage of participants
Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
Secondary
Percent Change From Baseline to Month 3 in Volume of the Largest Fibroid
The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available fibroid volume data at baseline and month 3.
Posted
Mean
Standard Deviation
percent change
Baseline and month 3
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
Secondary
Percentage of Participants With ≥ 25% Reduction in Volume of Largest Fibroid at Month 3 / Final Visit
The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available uterine volume data at baseline and month 3.
Posted
Number
percentage of participants
Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
Secondary
Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL)
The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components.
Lower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available UFS-QoL data at baseline and month 3.
Posted
Mean
Standard Deviation
units on a scale
Baseline and month 3
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
Secondary
Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores
The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary.
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.
Posted
Mean
Standard Deviation
units on a scale
Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90)
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
Secondary
Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0
The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery).
SSIQ included the 2 following questions:
How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now?
How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now?
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.
Posted
Mean
Standard Deviation
units on a scale
Baseline and month 3
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
Secondary
Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0
The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery).
The PSIQ included the 2 following questions:
How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now?
How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now?
Randomized (Cohorts 1, 2, and 4) or treated (Cohorts 3, 5, and 6) participants with available data at baseline and month 3.
Posted
Mean
Standard Deviation
units on a scale
Baseline and month 3
ID
Title
Description
OG000
Cohort 4 Elagolix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
OG001
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
OG002
Cohort 4 Placebo
Time Frame
From the date of the first dose of study drug through up to 30 days after the last dose of study drug, up to 4 months.
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
Participants received placebo to elagolix twice a day for 3 months.
0
18
1
18
8
18
EG001
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
0
35
0
35
26
35
EG002
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
0
16
0
16
10
16
EG003
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months
0
30
1
30
20
30
EG004
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
0
34
0
34
20
34
EG005
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
0
16
2
16
9
16
EG006
Cohort 4 Elagolix 100 mg BID
Participants received elagolix 100 mg twice a day (BID) for 3 months.
0
33
2
33
20
33
EG007
Cohort 4 Golix 400 mg QD
Participants received elagolix 400 mg once a day (QD) for 3 months.
0
32
0
32
24
32
EG008
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
0
30
2
30
22
30
EG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
0
27
0
27
11
27
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG0030 affected30 at risk
EG0040 affected34 at risk
EG0052 events2 affected16 at risk
EG0060 affected33 at risk
EG0070 affected32 at risk
EG0080 affected30 at risk
EG0090 affected27 at risk
UTERINE LEIOMYOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
NECROSIS
General disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
CHOLECYSTITIS
Hepatobiliary disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
HYPOVOLAEMIA
Metabolism and nutrition disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
UTERINE HAEMORRHAGE
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
PANCREATITIS
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
ABORTION INDUCED
Surgical and medical procedures
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0012 events2 affected35 at risk
EG0020 affected16 at risk
EG0035 events3 affected30 at risk
EG0040 affected34 at risk
EG0050 affected16 at risk
EG0060 affected33 at risk
EG0070 affected32 at risk
EG0082 events2 affected30 at risk
EG0095 events4 affected27 at risk
NAUSEA
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0014 events3 affected35 at risk
EG0022 events2 affected16 at risk
EG003
FATIGUE
General disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0012 events2 affected35 at risk
EG0020 affected16 at risk
EG003
OEDEMA PERIPHERAL
General disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
BRONCHITIS
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
VAGINITIS BACTERIAL
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected35 at risk
EG0021 events1 affected16 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
WEIGHT INCREASED
Investigations
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
DECREASED APPETITE
Metabolism and nutrition disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0012 events2 affected35 at risk
EG0021 events1 affected16 at risk
EG003
DIABETES MELLITUS
Metabolism and nutrition disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected35 at risk
EG0020 affected16 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0014 events3 affected35 at risk
EG0020 affected16 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0012 events2 affected35 at risk
EG0022 events2 affected16 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0013 events3 affected35 at risk
EG0023 events3 affected16 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
DEPRESSION
Psychiatric disorders
MedDRA (16.1)
Systematic Assessment
EG0002 events2 affected18 at risk
EG0011 events1 affected35 at risk
EG0020 affected16 at risk
EG003
MOOD SWINGS
Psychiatric disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0013 events2 affected35 at risk
EG0020 affected16 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0013 events2 affected35 at risk
EG0020 affected16 at risk
EG003
PELVIC PAIN
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0012 events2 affected35 at risk
EG0020 affected16 at risk
EG003
VULVOVAGINAL DRYNESS
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0012 events2 affected35 at risk
EG0020 affected16 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0013 events3 affected35 at risk
EG0021 events1 affected16 at risk
EG003
RASH GENERALISED
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
HOT FLUSH
Vascular disorders
MedDRA (16.1)
Systematic Assessment
EG0001 events1 affected18 at risk
EG00120 events19 affected35 at risk
EG0023 events3 affected16 at risk
EG003
ANAEMIA
Blood and lymphatic system disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
LEUKOCYTOSIS
Blood and lymphatic system disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
CHILLS
General disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
IRRITABILITY
General disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0022 events2 affected16 at risk
EG003
MALAISE
General disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
VESSEL PUNCTURE SITE PAIN
General disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
FUNGAL INFECTION
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0022 events2 affected16 at risk
EG003
VULVOVAGINITIS
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
BALANCE DISORDER
Nervous system disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
NEPHROLITHIASIS
Renal and urinary disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
SPIDER VEIN
Vascular disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0021 events1 affected16 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
LIBIDO DECREASED
Psychiatric disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
AMENORRHOEA
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
BREAST CYST
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
METRORRHAGIA
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
PEPTIC ULCER
Gastrointestinal disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
FURUNCLE
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
INFECTED BITES
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
OSTEOPENIA
Musculoskeletal and connective tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
DYSPAREUNIA
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
OVARIAN CYST
Reproductive system and breast disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
CHLOASMA
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
HYPERTENSION
Vascular disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
LACERATION
Injury, poisoning and procedural complications
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA (16.1)
Systematic Assessment
EG0000 affected18 at risk
EG0010 affected35 at risk
EG0020 affected16 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 (prior sponsor, Abbott)
800-633-9110
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
D011374
Progesterone
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
D011282
Pregnenediones
D011283
Pregnenes
D011278
Pregnanes
D003339
Corpus Luteum Hormones
D045167
Progesterone Congeners
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
1 subjects
FG0053 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
43.1
± 4.29
BG00444.0± 4.24
BG00540.9± 6.02
BG00640.8± 5.78
BG00742.6± 5.55
BG00841.6± 7.10
BG00941.6± 5.26
BG01041.8± 5.4
2
BG0032
BG0040
BG0055
BG0064
BG0073
BG0083
BG0093
BG01032
35 to < 40 years
BG0006
BG0015
BG0025
BG0035
BG0042
BG0058
BG0066
BG0075
BG0083
BG0096
BG01051
40 to < 45 years
BG0008
BG00113
BG0022
BG00313
BG0047
BG00510
BG00611
BG0079
BG0083
BG00910
BG01086
≥ 45 years
BG00011
BG00112
BG0027
BG00315
BG0049
BG00511
BG0069
BG00713
BG0087
BG0098
BG010102
16
BG00335
BG00418
BG00534
BG00630
BG00730
BG00816
BG00927
BG010271
Male
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
1
BG0031
BG0041
BG0051
BG0066
BG0070
BG0082
BG00912
BG01033
Not Hispanic or Latino
BG00031
BG00125
BG00215
BG00334
BG00417
BG00533
BG00624
BG00730
BG00814
BG00915
BG010238
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
3
BG0037
BG0043
BG0057
BG0065
BG0076
BG0086
BG00911
BG01063
Black
BG00025
BG00123
BG00213
BG00328
BG00414
BG00526
BG00624
BG00723
BG0089
BG00915
BG010200
Asian
BG0001
BG0010
BG0020
BG0030
BG0041
BG0051
BG0060
BG0070
BG0081
BG0090
BG0104
Other
BG0001
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0071
BG0080
BG0090
BG0103
Multirace
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0091
BG0101
32
OG00418
OG00533
OG00628
OG00730
OG00815
OG00926
335.11
± 322.68
OG004251.72± 160.29
OG005247.70± 177.72
OG006215.62± 122.84
OG007206.27± 125.08
OG008349.17± 424.12
OG009257.99± 207.33
Change from Baseline
Title
Measurements
OG000-183.97± 132.19
OG001-184.69± 187.05
OG002-10.46± 85.04
OG003-272.97± 271.39
OG004-79.00± 161.33
OG005-192.33± 191.51
OG006-189.05± 151.15
OG007-202.57± 127.93
OG008-175.31± 342.14
OG009-216.15± 157.08
ANCOVA model with treatment as a factor and baseline as a covariate.
< 0.001
LS Mean Difference
-189.9
Standard Error of the Mean
44.36
2-Sided
95
-278.33
-101.53
Superiority
OG003
OG004
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.001
LS Mean Difference
-138.0
Standard Error of the Mean
40.86
2-Sided
95
-220.18
-55.76
Superiority
OG007
OG008
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.001
LS Mean Difference
-130.6
Standard Error of the Mean
37.68
2-Sided
95
-206.70
-54.60
Superiority
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00031
OG00131
OG00215
OG00332
OG00418
OG00533
OG00628
OG00730
OG00815
OG00926
Title
Denominators
Categories
Title
Measurements
OG000-83.83± 35.23
OG001-71.85± 49.20
OG002-6.98± 40.78
OG003-81.03± 55.77
OG004-11.12± 103.11
OG005-79.60± 43.63
OG006-88.58± 39.58
OG007-97.31± 12.57
OG008-42.64± 39.68
OG009-85.39± 28.08
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
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
< 0.001
LS Mean Difference
-75.60
Standard Error of the Mean
13.71
2-Sided
95
-102.93
-48.28
Superiority
OG001
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
< 0.001
LS Mean Difference
-64.27
Standard Error of the Mean
13.48
2-Sided
95
-91.14
-37.39
Superiority
OG003
OG004
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.005
LS Mean Difference
-67.67
Standard Error of the Mean
22.73
2-Sided
95
-113.39
-21.96
Superiority
OG007
OG008
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
< 0.001
LS mean Difference
-56.84
Standard Error of the Mean
8.12
2-Sided
95
-73.24
-40.45
Superiority
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00031
OG00131
OG00215
OG00333
OG00418
OG00533
OG00628
OG00730
OG00815
OG00926
Title
Denominators
Categories
Title
Measurements
OG00084
OG00174
OG00213
OG00385
OG00417
OG00585
OG00693
OG00797
OG00833
OG00985
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
OG002
Fisher Exact
< 0.001
Superiority
OG001
OG002
Fisher Exact
< 0.001
Superiority
OG003
OG004
Fisher Exact
< 0.001
Superiority
OG007
OG008
Fisher Exact
< 0.001
Superiority
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00031
OG00131
OG00215
OG00333
OG00418
OG00533
OG00628
OG00730
OG00815
OG00926
Title
Denominators
Categories
Title
Measurements
OG00084
OG00174
OG00213
OG00385
OG00422
OG00588
OG00693
OG00797
OG00847
OG00988
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
OG002
Fisher Exact
< 0.001
Superiority
OG000
OG001
Fisher Exact
< 0.001
Superiority
OG003
OG004
Fisher Exact
< 0.001
Superiority
OG007
OG008
Fisher Exact
< 0.001
Superiority
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00031
OG00131
OG00215
OG00333
OG00418
OG00533
OG00628
OG00730
OG00815
OG00926
Title
Denominators
Categories
Title
Measurements
OG00084
OG00174
OG00213
OG00391
OG00428
OG00585
OG00693
OG00797
OG00840
OG00988
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
OG002
Fisher Exact
< 0.001
Superiority
OG001
OG002
Fisher Exact
< 0.001
Superiority
OG003
OG004
Fisher Exact
< 0.001
Superiority
OG007
OG008
Fisher Exact
< 0.001
Superiority
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00023
OG00124
OG00211
OG00327
OG00414
OG00528
OG00623
OG00725
OG00814
OG00921
Title
Denominators
Categories
No Change
Title
Measurements
OG0000
OG0010
OG0029
OG0030
OG0040
OG0050
OG0064
OG0070
OG0080
OG0095
Decreases from -0.5 to 0 g/dL
Title
Measurements
OG0009
OG00117
OG0020
OG003
Decreases from -1.0 to -0.5 g/dL
Title
Measurements
OG0004
OG0014
OG00227
OG003
Increase ≥ 0.5 g/dL
Title
Measurements
OG00078
OG00171
OG00218
OG003
Increase ≥ 1.0 g/dL
Title
Measurements
OG00061
OG00171
OG0029
OG003
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00023
OG00124
OG00211
OG00327
OG00414
OG00528
OG00623
OG00725
OG00814
OG00921
Title
Denominators
Categories
Title
Measurements
OG0001.18± 0.99
OG0011.30± 1.19
OG002-0.43± 1.28
OG0031.13± 1.29
OG0040.28± 1.33
OG0050.92± 0.81
OG0061.40± 1.18
OG0071.19± 0.85
OG0080.31± 1.20
OG0091.54± 1.81
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
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
< 0.001
LS Mean Difference
1.8
Standard Error of the Mean
0.40
2-Sided
95
0.97
2.56
Superiority
OG001
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
< 0.001
LS Mean Difference
1.8
Standard Error of the Mean
0.39
2-Sided
95
1.00
2.56
Superiority
OG003
OG004
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.024
LS Mean Difference
0.9
Standard Error of the Mean
0.40
2-Sided
95
0.13
1.75
Superiority
OG007
OG008
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.005
LS Mean Difference
0.9
Standard Error of the Mean
0.30
2-Sided
95
0.28
1.51
Superiority
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00030
OG00130
OG00215
OG00332
OG00417
OG00532
OG00626
OG00727
OG00815
OG00925
Title
Denominators
Categories
Title
Measurements
OG000-0.50± 0.56
OG001-0.37± 0.46
OG002-0.19± 0.33
OG003-0.52± 0.65
OG004-0.22± 0.32
OG005-0.24± 0.47
OG006-0.44± 0.71
OG007-0.53± 0.33
OG008-0.38± 0.77
OG009-0.25± 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
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.011
LS Mean Difference
-0.36
Standard Error of the Mean
0.14
2-Sided
95
-0.63
-0.08
Superiority
OG001
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.030
LS Mean Difference
-0.31
Standard Error of the Mean
0.14
2-Sided
95
-0.59
-0.03
Superiority
OG003
OG004
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.109
LS Mean Difference
-0.26
Standard Error of the Mean
0.16
2-Sided
95
-0.59
0.06
Superiority
OG007
OG008
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.002
LS Mean Difference
-0.50
Standard Error of the Mean
0.15
2-Sided
95
-0.80
-0.19
Superiority
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00030
OG00130
OG00215
OG00332
OG00417
OG00532
OG00626
OG00727
OG00815
OG00925
Title
Denominators
Categories
Title
Measurements
OG000-15.22± 14.77
OG001-11.00± 15.52
OG002-5.78± 10.58
OG003-15.82± 17.88
OG004-6.99± 12.82
OG0053.63± 24.74
OG006-15.38± 23.21
OG007-16.91± 11.13
OG008-13.95± 23.83
OG0091.73± 26.09
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
ANCOVA model with treatment as a factor and baseline as a covariate.
0.020
LS Mean Difference
-10.29
Standard Error of the Mean
4.32
2-Sided
95
-18.90
-1.67
Superiority
OG001
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.087
LS Mean Difference
-7.62
Standard Error of the Mean
4.39
2-Sided
95
-16.36
1.13
Superiority
OG003
OG004
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.045
LS Mean Difference
-8.81
Standard Error of the Mean
4.28
2-Sided
95
-17.43
-0.19
Superiority
OG007
OG008
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.002
LS Mean Difference
-13.69
Standard Error of the Mean
4.14
2-Sided
95
-22.06
-5.32
Superiority
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00030
OG00130
OG00215
OG00332
OG00417
OG00532
OG00626
OG00727
OG00815
OG00925
Title
Denominators
Categories
Title
Measurements
OG000-7.22± 9.27
OG001-5.00± 7.87
OG002-4.00± 5.37
OG003-7.03± 10.89
OG004-3.08± 5.88
OG005-7.92± 6.43
OG006-6.15± 8.47
OG007-8.02± 5.41
OG008-3.31± 10.40
OG009-6.80± 10.69
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
OG002
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.008
LS Mean Difference
-5.51
Standard Error of the Mean
2.03
2-Sided
95
-9.56
-1.47
Superiority
OG001
OG002
ANCOVA
0.020
LS Mean Difference
-4.95
Standard Error of the Mean
2.08
2-Sided
95
-9.11
-0.80
Superiority
OG003
OG004
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.194
LS Mean Difference
-3.63
Standard Error of the Mean
2.75
2-Sided
95
-9.18
1.91
Superiority
OG007
OG008
ANCOVA
ANCOVA model with treatment as a factor and baseline as a covariate.
0.001
LS Mean Difference
-7.20
Standard Error of the Mean
2.04
2-Sided
95
-11.33
-3.07
Superiority
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00030
OG00130
OG00215
OG00332
OG00417
OG00532
OG00626
OG00727
OG00815
OG00926
Title
Denominators
Categories
Any bleeding
Title
Measurements
OG00037
OG00157
OG00293
OG00347
OG00494
OG00578
OG00627
OG00726
OG00880
OG00969
Moderate to Very Heavy Bleeding
Title
Measurements
OG00027
OG00140
OG00287
OG003
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00030
OG00129
OG00215
OG00332
OG00418
OG00532
OG00626
OG00729
OG00816
OG00926
Title
Denominators
Categories
Suppression of bleeding
Title
Measurements
OG00066
OG00145
OG0020
OG00366
OG0040
OG00531
OG00677
OG00779
OG0080
OG00932
Amenorrhea
Title
Measurements
OG00060
OG00131
OG0020
OG003
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00022
OG00120
OG0029
OG00322
OG00412
OG00522
OG00620
OG00720
OG00812
OG00911
Title
Denominators
Categories
Title
Measurements
OG000-21.01± 26.79
OG001-21.37± 24.84
OG00218.72± 15.59
OG003-21.68± 29.80
OG004-8.62± 20.58
OG005-17.43± 19.51
OG006-27.99± 23.34
OG007-33.25± 16.55
OG008-1.92± 17.52
OG009-10.06± 30.93
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
Kruskal-Wallis
One-way Kruskal-Wallis test with treatment as a factor.
< 0.001
Superiority
OG001
OG002
Kruskal-Wallis
One-way Kruskal-Wallis test with treatment as a factor.
< 0.001
Superiority
OG003
OG004
Kruskal-Wallis
One-way Kruskal-Wallis test with treatment as a factor.
0.052
Superiority
OG007
OG008
Kruskal-Wallis
One-way Kruskal-Wallis test with treatment as a factor.
< 0.001
Superiority
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00030
OG00130
OG00215
OG00331
OG00418
OG00533
OG00627
OG00729
OG00815
OG00924
Title
Denominators
Categories
Title
Measurements
OG00053
OG00143
OG0027
OG00348
OG00411
OG00542
OG00656
OG00769
OG0087
OG00925
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
0.003
Superiority
OG001
OG002
Fisher Exact
0.016
Superiority
OG003
OG004
Fisher Exact
0.012
Superiority
OG007
OG008
Fisher Exact
< 0.001
Superiority
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00019
OG00118
OG0029
OG00322
OG00412
OG00522
OG00618
OG00720
OG00812
OG00910
Title
Denominators
Categories
Title
Measurements
OG00014.23± 187.83
OG001-22.19± 51.14
OG002-7.26± 36.35
OG003-38.52± 41.72
OG004-2.05± 71.83
OG005-25.77± 46.64
OG006-16.60± 39.61
OG007-35.79± 24.49
OG0086.70± 45.42
OG009-4.94± 100.68
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
Kruskal-Wallis
One-way Kruskal-Wallis test with treatment as a factor
0.161
Superiority
OG001
OG002
Kruskal-Wallis
One-way Kruskal-Wallis test with treatment as a factor.
0.173
Superiority
OG003
OG004
Kruskal-Wallis
One-way Kruskal-Wallis test with treatment as a factor.
0.072
Superiority
OG007
OG008
Kruskal-Wallis
One-way Kruskal-Wallis test with treatment as a factor.
0.003
Superiority
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00028
OG00129
OG00215
OG00331
OG00417
OG00533
OG00625
OG00729
OG00815
OG00921
Title
Denominators
Categories
Title
Measurements
OG00057
OG00152
OG00233
OG00368
OG00435
OG00558
OG00660
OG00755
OG00827
OG00948
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
0.203
Superiority
OG001
OG002
Fisher Exact
0.342
Superiority
OG003
OG004
Fisher Exact
0.038
Superiority
OG007
OG008
Fisher Exact
0.111
Superiority
OG002
Cohort 4 Placebo
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00023
OG00121
OG0029
OG00326
OG00413
OG00522
OG00620
OG00725
OG00813
OG00914
Title
Denominators
Categories
Symptom severity
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG0029
ParticipantsOG00326
ParticipantsOG00413
ParticipantsOG00522
ParticipantsOG00620
ParticipantsOG00725
ParticipantsOG00813
ParticipantsOG00914
Title
Measurements
OG000-39.0± 24.70
OG001-33.2± 28.17
OG002-19.6± 32.80
OG003
HRQL total
ParticipantsOG00022
ParticipantsOG00121
ParticipantsOG0029
ParticipantsOG00325
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00018
OG00118
OG0029
OG00318
OG00411
OG00522
OG00616
OG00720
OG0089
OG00911
Title
Denominators
Categories
Pelvic pain
Title
Measurements
OG000-1.0± 2.27
OG001-0.2± 2.39
OG002-0.3± 1.45
OG003-0.6± 1.75
OG004-1.4± 1.62
OG005-1.1± 1.35
OG006-0.9± 2.15
OG007-1.0± 1.75
OG008-1.2± 1.73
OG009-2.4± 3.00
Fatigue
Title
Measurements
OG000-0.5± 1.26
OG001-0.0± 2.23
OG002-0.6± 1.45
OG003
Menstrual cramping
Title
Measurements
OG000-1.2± 1.31
OG001-0.7± 2.51
OG002-0.5± 1.55
OG003
Impact of uterine fibroids
Title
Measurements
OG000-1.1± 1.18
OG001-0.4± 1.86
OG002-0.8± 1.40
OG003
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
Units
Counts
Participants
OG00023
OG00121
OG0029
OG0039
OG0046
OG00522
OG00620
OG00725
OG00813
OG00914
Title
Denominators
Categories
Likelihood of having myomectomy
ParticipantsOG00023
ParticipantsOG00121
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG0046
ParticipantsOG00522
ParticipantsOG00620
ParticipantsOG00725
ParticipantsOG00813
ParticipantsOG00914
Title
Measurements
OG000-1.2± 3.68
OG001-3.1± 4.52
OG0021.0± 2.12
OG003
Likelihood of having hysterectomy
ParticipantsOG00023
ParticipantsOG00120
ParticipantsOG0029
ParticipantsOG0039
Participants received placebo to elagolix BID for 3 months.
OG003
Cohort 1 Elagolix 200 mg BID
Participants received elagolix 200 mg twice a day for 3 months.
OG004
Cohort 1 Placebo
Participants received placebo to elagolix twice a day for 3 months.
OG005
Cohort 3 Elagolix 200 mg BID + LD E2/NETA
Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
OG006
Cohort 5 Elagolix 600 mg QD
Participants received elagolix 600 mg once a day for 3 months.
OG007
Cohort 2 Elagolix 300 mg BID
Participants received elagolix 300 mg twice a day for 3 months.
OG008
Cohort 2 Placebo
Participants received placebo to elagolix BID for 3 months.
OG009
Cohort 6 Elagolix 300 mg BID + CEP
Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.