Heavy Menstrual Bleeding, Uterine Fibroids
Conditions
Keywords
Uterine Fibroids, Elagolix, Heavy Menstrual Bleeding, Elagolix Sodium, Elagolix plus Norethindrone Acetate
Brief summary
This is an extension study for women who have already received six months of treatment in the phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate the long-term efficacy and safety of elagolix administered alone and in combination with estradiol/norethindrone acetate for an additional six months in the treatment of heavy menstrual bleeding associated with uterine fibroids.
Interventions
capsules
DRUGElagolix
film-coated tablets
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 51 Years
Healthy volunteers
No
Inclusion criteria
* Participant has completed the 6-Month Treatment Period of their respective Pivotal Study (either Study M12-815 or Study M12-817). * Participant did not meet removal criteria in bone mineral density (BMD) decrease in the spine, total hip and femoral neck at Month 6 of the Treatment Period of their respective Pivotal Study * Participant has negative urine and/or serum pregnancy test(s) results were consistently negative during the Treatment Period of their respective Pivotal Study and prior to first dose in this study. * Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal Study shows no clinically significant endometrial pathology.
Exclusion criteria
* Participant met criteria for removal from therapy in her respective Pivotal Study. * Participant is planning a pregnancy within the next 18 months. * Participant has current suicidal markers as noted at the Month 6 visit of her respective pivotal study. * Participant has any new medical conditions that may be unsuitable for participation. * Participant is using any systemic corticosteroids for over 14 days or is likely to require treatment with systemic corticosteroids during the course of the study. Over-the-counter and prescription topical, inhaled, intranasal or injectable (for occasional use) corticosteroids are allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting the Criteria for Responder | From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study) | Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to lack of efficacy, requires surgery or invasive intervention for treatment of uterine fibroids, or adverse events were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6) | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. |
| Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6) | Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. |
| Percentage of Participants With Suppression of Bleeding at the Final Month | Final Month of Treatment Period (up through Month 6) | Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11. |
| Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period | Month 6 | — |
Countries
Canada, Puerto Rico, United States
Participant flow
Recruitment details
A total of 433 participants who completed the 6-month Treatment Period in pivotal studies M12-815 (NCT02654054) or M12-817 (NCT02691494) were enrolled in this extension study at 114 sites in 2 countries (US \[including Puerto Rico\] and Canada).
Pre-assignment details
A total of 433 participants were treated in this extension study and were grouped according to the treatment assignments in pivotal studies M12-815 and M12-817 and this extension study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo->Elagolix Placebo in pivotal study and elagolix 300 mg BID in extension study. | 59 |
| Placebo->Elagolix + E2/NETA Placebo in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | 58 |
| Elagolix->Elagolix Elagolix 300 mg BID in pivotal study and elagolix 300 mg BID in extension study. | 98 |
| Elagolix + E2/NETA->Elagolix + E2/NETA Elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in pivotal study and elagolix 300 mg BID plus E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD in extension study. | 218 |
| Total | 433 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Post-Treatment Follow-Up Period | Adverse Event | 0 | 0 | 0 | 1 |
| Post-Treatment Follow-Up Period | Lost to Follow-up | 3 | 2 | 9 | 10 |
| Post-Treatment Follow-Up Period | Non-Compliance | 0 | 0 | 1 | 2 |
| Post-Treatment Follow-Up Period | Other | 1 | 4 | 3 | 6 |
| Post-Treatment Follow-Up Period | Pregnancy | 1 | 0 | 1 | 2 |
| Post-Treatment Follow-Up Period | Required Surgery/ Invasive Intervention | 1 | 2 | 2 | 6 |
| Post-Treatment Follow-Up Period | Withdrawal by Subject | 8 | 2 | 8 | 23 |
Baseline characteristics
| Characteristic | Placebo->Elagolix + E2/NETA | Elagolix->Elagolix | Placebo->Elagolix | Elagolix + E2/NETA->Elagolix + E2/NETA | Total |
|---|---|---|---|---|---|
| Age, Customized 25 to < 30 years | 3 Participants | 1 Participants | 0 Participants | 4 Participants | 8 Participants |
| Age, Customized 30 to < 35 years | 2 Participants | 7 Participants | 4 Participants | 19 Participants | 32 Participants |
| Age, Customized 35 to < 40 years | 10 Participants | 18 Participants | 12 Participants | 34 Participants | 74 Participants |
| Age, Customized 40 to < 45 years | 21 Participants | 36 Participants | 20 Participants | 74 Participants | 151 Participants |
| Age, Customized 45 to < 50 years | 16 Participants | 30 Participants | 16 Participants | 77 Participants | 139 Participants |
| Age, Customized >= 50 years | 6 Participants | 6 Participants | 7 Participants | 10 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 9 Participants | 7 Participants | 33 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 89 Participants | 52 Participants | 185 Participants | 377 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 70 Participants | 43 Participants | 146 Participants | 298 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 19 Participants | 25 Participants | 13 Participants | 65 Participants | 122 Participants |
| Sex: Female, Male Female | 58 Participants | 98 Participants | 59 Participants | 218 Participants | 433 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 1 / 58 | 0 / 98 | 0 / 218 |
| other Total, other adverse events | 38 / 59 | 26 / 58 | 25 / 98 | 50 / 218 |
| serious Total, serious adverse events | 1 / 59 | 3 / 58 | 2 / 98 | 6 / 218 |
Outcome results
Primary
Percentage of Participants Meeting the Criteria for Responder
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to lack of efficacy, requires surgery or invasive intervention for treatment of uterine fibroids, or adverse events were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
Time frame: From Month 0 (Baseline in Pivotal Study) to Final Month of Treatment Period (up through Month 6 in Extension Study)
Population: All participants who received at least 1 dose of study drug and had an assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo->Elagolix | Percentage of Participants Meeting the Criteria for Responder | 85.7 percentage of participants |
| Placebo->Elagolix + E2/NETA | Percentage of Participants Meeting the Criteria for Responder | 66.7 percentage of participants |
| Elagolix->Elagolix | Percentage of Participants Meeting the Criteria for Responder | 89.4 percentage of participants |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percentage of Participants Meeting the Criteria for Responder | 87.9 percentage of participants |
Secondary
Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Time frame: Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
Population: All participants who received at least 1 dose of study drug and had an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Final Month | -256.6 mL | Standard Deviation 194.04 |
| Placebo->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 85 to 112 | -235.1 mL | Standard Deviation 184.87 |
| Placebo->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 113 to 140 | -237.3 mL | Standard Deviation 234 |
| Placebo->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 29 to 56 | -210.9 mL | Standard Deviation 234.01 |
| Placebo->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 1 to 28 | -151.7 mL | Standard Deviation 184.76 |
| Placebo->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 141 to 168 | -263.8 mL | Standard Deviation 199.83 |
| Placebo->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 57 to 84 | -236.9 mL | Standard Deviation 162.33 |
| Placebo->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 57 to 84 | -209.0 mL | Standard Deviation 184.9 |
| Placebo->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 113 to 140 | -194.5 mL | Standard Deviation 213.69 |
| Placebo->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 29 to 56 | -203.1 mL | Standard Deviation 188.15 |
| Placebo->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 85 to 112 | -204.5 mL | Standard Deviation 177.65 |
| Placebo->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 1 to 28 | -61.7 mL | Standard Deviation 212.01 |
| Placebo->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 141 to 168 | -175.4 mL | Standard Deviation 115.43 |
| Placebo->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Final Month | -186.4 mL | Standard Deviation 138.16 |
| Elagolix->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 57 to 84 | -255.9 mL | Standard Deviation 175.43 |
| Elagolix->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Final Month | -250.3 mL | Standard Deviation 182.09 |
| Elagolix->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 1 to 28 | -253.4 mL | Standard Deviation 190.07 |
| Elagolix->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 141 to 168 | -279.1 mL | Standard Deviation 191.44 |
| Elagolix->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 29 to 56 | -249.7 mL | Standard Deviation 189.81 |
| Elagolix->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 85 to 112 | -252.0 mL | Standard Deviation 175.23 |
| Elagolix->Elagolix | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 113 to 140 | -253.9 mL | Standard Deviation 173.5 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 57 to 84 | -200.6 mL | Standard Deviation 159.77 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 1 to 28 | -186.5 mL | Standard Deviation 164.38 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 113 to 140 | -192.9 mL | Standard Deviation 165.42 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 29 to 56 | -191.9 mL | Standard Deviation 166.38 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Final Month | -205.6 mL | Standard Deviation 151.55 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 141 to 168 | -211.4 mL | Standard Deviation 165.26 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 85 to 112 | -200.5 mL | Standard Deviation 156.85 |
Secondary
Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period
Time frame: Month 6
Population: All participants who received at least 1 dose of study drug, had a baseline hemoglobin concentration of \<= 10.5 g/dL and had an assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo->Elagolix | Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period | 70.6 percentage of participants |
| Placebo->Elagolix + E2/NETA | Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period | 36.4 percentage of participants |
| Elagolix->Elagolix | Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period | 71.4 percentage of participants |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percentage of Participants With Baseline Hemoglobin Concentration ≤ 10.5 g/dL and an Increase From Baseline > 2 g/dL at Month 6 During the Treatment Period | 72.5 percentage of participants |
Secondary
Percentage of Participants With Suppression of Bleeding at the Final Month
Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.
Time frame: Final Month of Treatment Period (up through Month 6)
Population: All participants who received at least 1 dose of study drug and had an assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo->Elagolix | Percentage of Participants With Suppression of Bleeding at the Final Month | 88.7 percentage of participants |
| Placebo->Elagolix + E2/NETA | Percentage of Participants With Suppression of Bleeding at the Final Month | 56.0 percentage of participants |
| Elagolix->Elagolix | Percentage of Participants With Suppression of Bleeding at the Final Month | 89.2 percentage of participants |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percentage of Participants With Suppression of Bleeding at the Final Month | 74.8 percentage of participants |
Secondary
Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period of the pivotal study, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.
Time frame: Month 0 (Baseline in Pivotal Study), Extension Study: Day 1 to 28, Day 29 to 56, Day 57 to 84, Day 85 to 112, Day 113 to 140, Day 141 to 168, Final Month of Treatment Period (up through Month 6)
Population: All participants who received at least 1 dose of study drug and had an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 1 to 28 | -46.5 percentage change | Standard Deviation 66.57 |
| Placebo->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 141 to 168 | -91.8 percentage change | Standard Deviation 30.77 |
| Placebo->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 113 to 140 | -90.0 percentage change | Standard Deviation 40.38 |
| Placebo->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 29 to 56 | -87.2 percentage change | Standard Deviation 46.33 |
| Placebo->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Final Month | -91.0 percentage change | Standard Deviation 28.74 |
| Placebo->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 57 to 84 | -89.9 percentage change | Standard Deviation 37.62 |
| Placebo->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 85 to 112 | -90.3 percentage change | Standard Deviation 30.26 |
| Placebo->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 141 to 168 | -79.3 percentage change | Standard Deviation 32.25 |
| Placebo->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 85 to 112 | -82.7 percentage change | Standard Deviation 32.76 |
| Placebo->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 57 to 84 | -82.9 percentage change | Standard Deviation 34.79 |
| Placebo->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 113 to 140 | -75.0 percentage change | Standard Deviation 65.97 |
| Placebo->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Final Month | -78.5 percentage change | Standard Deviation 36.76 |
| Placebo->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 29 to 56 | -79.4 percentage change | Standard Deviation 41.8 |
| Placebo->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 1 to 28 | -28.2 percentage change | Standard Deviation 72.69 |
| Elagolix->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 85 to 112 | -95.2 percentage change | Standard Deviation 19.38 |
| Elagolix->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 1 to 28 | -94.0 percentage change | Standard Deviation 24.9 |
| Elagolix->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 29 to 56 | -93.3 percentage change | Standard Deviation 28.77 |
| Elagolix->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 57 to 84 | -96.9 percentage change | Standard Deviation 16.88 |
| Elagolix->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 113 to 140 | -97.7 percentage change | Standard Deviation 13.01 |
| Elagolix->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 141 to 168 | -99.2 percentage change | Standard Deviation 4.31 |
| Elagolix->Elagolix | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Final Month | -96.6 percentage change | Standard Deviation 18.29 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 57 to 84 | -90.6 percentage change | Standard Deviation 32.6 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Final Month | -90.8 percentage change | Standard Deviation 33.01 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 141 to 168 | -89.7 percentage change | Standard Deviation 36.67 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 29 to 56 | -87.8 percentage change | Standard Deviation 43.17 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 1 to 28 | -87.7 percentage change | Standard Deviation 36.24 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 113 to 140 | -87.5 percentage change | Standard Deviation 40.67 |
| Elagolix + E2/NETA->Elagolix + E2/NETA | Percent Change From Baseline in MBL Volume For Each 28-Day Interval and Final Month of the Treatment Period | Study Day 85 to 112 | -91.2 percentage change | Standard Deviation 28.42 |