Trial Outcomes & Findings for Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF) (NCT NCT01817530)
NCT ID: NCT01817530
Last Updated: 2020-07-21
Results Overview
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of \< 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
571 participants
Primary outcome timeframe
Baseline, Final Month (last 28 days of treatment)
Results posted on
2020-07-21
Participant Flow
Overall, 571 female participants were enrolled into the study across 86 sites (5 sites in the UK, 4 in Chile, 2 in Canada, 4 in Puerto Rico, and 71 in the US).
Four participants were randomized in error; they were not dosed and were excluded from all analyses including demographic summaries.
Participant milestones
| Measure |
Cohort 1: Placebo
Placebo for elagolix twice daily (BID) and placebo for E2/NETA once daily (QD)
|
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus low-dose (LD) E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
|
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
65
|
64
|
65
|
78
|
77
|
76
|
77
|
|
Overall Study
COMPLETED
|
50
|
52
|
53
|
52
|
67
|
58
|
53
|
53
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
11
|
13
|
11
|
19
|
23
|
24
|
Reasons for withdrawal
| Measure |
Cohort 1: Placebo
Placebo for elagolix twice daily (BID) and placebo for E2/NETA once daily (QD)
|
Cohort 1: Elagolix 300 mg BID
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Elagolix 300 mg BID plus low-dose (LD) E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Elagolix 300 mg BID plus standard-dose (SD) E2/NETA QD
|
Cohort 2: Placebo
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Exclusionary Medication Received
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
6
|
3
|
2
|
5
|
0
|
10
|
5
|
8
|
|
Overall Study
Subject Noncompliant
|
3
|
1
|
0
|
4
|
0
|
1
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Pregnancy
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
1
|
0
|
0
|
1
|
0
|
5
|
0
|
|
Overall Study
Surgery or Invasive Intervention
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Consent Withdrawn by Subject
|
3
|
4
|
7
|
3
|
5
|
3
|
3
|
10
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
2
|
1
|
3
|
2
|
8
|
4
|
Baseline Characteristics
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Baseline characteristics by cohort
| Measure |
Cohort 1: Placebo
n=65 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
Total
n=567 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.5 years
STANDARD_DEVIATION 6.14 • n=5 Participants
|
42.0 years
STANDARD_DEVIATION 4.76 • n=7 Participants
|
43.0 years
STANDARD_DEVIATION 5.02 • n=5 Participants
|
43.8 years
STANDARD_DEVIATION 4.66 • n=4 Participants
|
42.3 years
STANDARD_DEVIATION 4.78 • n=21 Participants
|
42.1 years
STANDARD_DEVIATION 4.93 • n=8 Participants
|
41.1 years
STANDARD_DEVIATION 5.74 • n=8 Participants
|
42.2 years
STANDARD_DEVIATION 5.40 • n=24 Participants
|
42.3 years
STANDARD_DEVIATION 5.22 • n=42 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
77 Participants
n=8 Participants
|
76 Participants
n=8 Participants
|
77 Participants
n=24 Participants
|
567 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline, Final Month (last 28 days of treatment)Population: Modified Intent-to-Treat (ITT): randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 28 days of treatment.
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of \< 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=64 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=62 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=61 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=62 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=76 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=71 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=73 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a Menstrual Blood Loss (MBL) Volume of < 80 mL at the Final Month and a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
|
26.56 percentage of participants
|
91.94 percentage of participants
|
85.25 percentage of participants
|
79.03 percentage of participants
|
31.58 percentage of participants
|
90.14 percentage of participants
|
72.6 percentage of participants
|
81.58 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 56 days of treatment.
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume \< 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=62 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=58 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=59 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=60 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=76 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=68 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=64 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=70 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 56 to 29 Days of Treatment
|
11.29 percentage of participants
|
94.83 percentage of participants
|
88.14 percentage of participants
|
85.00 percentage of participants
|
18.42 percentage of participants
|
85.29 percentage of participants
|
67.19 percentage of participants
|
77.14 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 84 days of treatment.
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume \< 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=61 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=56 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=57 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=58 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=74 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=66 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=62 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=65 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a MBL Volume < 80 mL and a ≥ 50% Reduction in MBL Volume From Baseline During the Last 84 to 57 Days of Treatment
|
19.67 percentage of participants
|
96.43 percentage of participants
|
89.47 percentage of participants
|
79.31 percentage of participants
|
21.62 percentage of participants
|
86.36 percentage of participants
|
74.19 percentage of participants
|
72.31 percentage of participants
|
SECONDARY outcome
Timeframe: Final Month (last 28 days of treatment)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 28 days of treatment.
Percentage of participants who achieved an MBL volume of \< 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=64 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=62 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=61 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=62 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=76 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=71 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=73 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved an MBL Volume of < 80 mL at the Final Month
|
32.81 percentage of participants
|
91.94 percentage of participants
|
88.52 percentage of participants
|
79.03 percentage of participants
|
36.84 percentage of participants
|
91.55 percentage of participants
|
72.6 percentage of participants
|
85.53 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Final Month (last 28 days of treatment)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 28 days of treatment.
Percentage of participants with a \>= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period.
Outcome measures
| Measure |
Cohort 1: Placebo
n=64 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=62 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=61 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=62 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=76 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=71 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=73 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥ 50% Reduction in MBL Volume From Baseline to the Final Month
|
31.25 percentage of participants
|
93.55 percentage of participants
|
86.89 percentage of participants
|
82.26 percentage of participants
|
35.53 percentage of participants
|
90.14 percentage of participants
|
79.45 percentage of participants
|
85.53 percentage of participants
|
SECONDARY outcome
Timeframe: Last 56 days of treatment (after 10 days from first dose date)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 66 days of treatment.
Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment.
Outcome measures
| Measure |
Cohort 1: Placebo
n=61 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=57 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=57 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=60 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=75 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=67 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=63 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=66 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Amenorrhea During the Last 56 Days of Treatment
|
1.6 percentage of participants
|
56.1 percentage of participants
|
33.3 percentage of participants
|
28.3 percentage of participants
|
1.3 percentage of participants
|
50.7 percentage of participants
|
17.5 percentage of participants
|
22.7 percentage of participants
|
SECONDARY outcome
Timeframe: Last 56 days of treatment (after 10 days from first dose date)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Excludes participants with \< 66 days of treatment.
Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment.
Outcome measures
| Measure |
Cohort 1: Placebo
n=61 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=57 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=57 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=60 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=75 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=67 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=63 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=66 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Achieved Suppression of Bleeding During the Last 56 Days of Treatment
|
1.6 percentage of participants
|
75.4 percentage of participants
|
52.6 percentage of participants
|
43.3 percentage of participants
|
2.7 percentage of participants
|
67.2 percentage of participants
|
31.7 percentage of participants
|
34.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and Month 6.
The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
Outcome measures
| Measure |
Cohort 1: Placebo
n=37 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=11 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=26 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=30 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=47 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=15 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=26 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=28 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change in the Number of Bleeding Days From Baseline to Month 6
|
-1.2 days
Standard Error 0.63
|
-4.9 days
Standard Error 1.15
|
-2.7 days
Standard Error 0.75
|
-1.1 days
Standard Error 0.69
|
-1.4 days
Standard Error 0.49
|
-3.3 days
Standard Error 0.87
|
-1.3 days
Standard Error 0.66
|
-1.8 days
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and Month 6.
The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug.
Outcome measures
| Measure |
Cohort 1: Placebo
n=37 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=11 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=26 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=30 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=47 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=15 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=26 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=28 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change in the Number of Heavy Bleeding Days From Baseline to Month 6
|
-1.0 days
Standard Error 0.15
|
-2.0 days
Standard Error 0.27
|
-1.9 days
Standard Error 0.18
|
-1.7 days
Standard Error 0.16
|
-0.7 days
Standard Error 0.14
|
-1.2 days
Standard Error 0.25
|
-1.4 days
Standard Error 0.19
|
-1.8 days
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, Final Month (last 28 days of treatment)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and final month.
The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug.
Outcome measures
| Measure |
Cohort 1: Placebo
n=51 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=19 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=33 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=37 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=61 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=24 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=48 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=42 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Change in Bleeding Severity Scores From Baseline at the Final Month
|
-0.3 units on a scale
Standard Error 0.08
|
-0.7 units on a scale
Standard Error 0.14
|
-0.4 units on a scale
Standard Error 0.10
|
-0.1 units on a scale
Standard Error 0.10
|
-0.2 units on a scale
Standard Error 0.08
|
-0.4 units on a scale
Standard Error 0.14
|
-0.3 units on a scale
Standard Error 0.10
|
-0.1 units on a scale
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Baseline, Final Visit during treatment period (Month 6 or early termination)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and final month.
Baseline is defined as the last measurement prior to the first dose of study drug.
Outcome measures
| Measure |
Cohort 1: Placebo
n=64 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=61 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=59 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=61 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=76 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=71 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=72 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=74 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Mean Change in Hemoglobin Concentration From Baseline to Final Visit
|
0.6 g/dL
Standard Error 0.17
|
1.9 g/dL
Standard Error 0.17
|
1.9 g/dL
Standard Error 0.17
|
1.4 g/dL
Standard Error 0.17
|
0.3 g/dL
Standard Error 0.15
|
1.4 g/dL
Standard Error 0.16
|
1.1 g/dL
Standard Error 0.16
|
1.2 g/dL
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and final month.
Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound.
Outcome measures
| Measure |
Cohort 1: Placebo
n=65 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Month 3
|
1.7 percentage change
Standard Deviation 33.61
|
-41.9 percentage change
Standard Deviation 24.87
|
-24.6 percentage change
Standard Deviation 27.58
|
-9.8 percentage change
Standard Deviation 40.31
|
5.4 percentage change
Standard Deviation 27.18
|
-34.4 percentage change
Standard Deviation 25.56
|
-17.5 percentage change
Standard Deviation 27.76
|
-4.6 percentage change
Standard Deviation 39.97
|
|
Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Month 6
|
8.3 percentage change
Standard Deviation 50.97
|
-40.2 percentage change
Standard Deviation 27.6
|
-23.3 percentage change
Standard Deviation 30.34
|
-8.8 percentage change
Standard Deviation 47.81
|
-1.8 percentage change
Standard Deviation 30.1
|
-34.2 percentage change
Standard Deviation 31.14
|
-17.8 percentage change
Standard Deviation 30.49
|
-1.1 percentage change
Standard Deviation 46.66
|
|
Mean Percentage Change From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Final Visit
|
4.6 percentage change
Standard Deviation 48.59
|
-39.6 percentage change
Standard Deviation 28.66
|
-24.0 percentage change
Standard Deviation 29.93
|
-12.9 percentage change
Standard Deviation 46.2
|
0.1 percentage change
Standard Deviation 28.82
|
-36.4 percentage change
Standard Deviation 30.07
|
-16.6 percentage change
Standard Deviation 32.65
|
-1.6 percentage change
Standard Deviation 42.75
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound.
Outcome measures
| Measure |
Cohort 1: Placebo
n=65 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Month 3
|
6.9 percentage change
Standard Deviation 35.31
|
-35.5 percentage change
Standard Deviation 26.32
|
-20.3 percentage change
Standard Deviation 33.54
|
-3.7 percentage change
Standard Deviation 39.13
|
6.7 percentage change
Standard Deviation 27.66
|
-33.6 percentage change
Standard Deviation 23.74
|
-17.2 percentage change
Standard Deviation 27.39
|
-1.9 percentage change
Standard Deviation 39.22
|
|
Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Month 6
|
13.2 percentage change
Standard Deviation 48.65
|
-36.1 percentage change
Standard Deviation 30.59
|
-19.6 percentage change
Standard Deviation 32.1
|
0.0 percentage change
Standard Deviation 47.07
|
1.4 percentage change
Standard Deviation 30.03
|
-33.5 percentage change
Standard Deviation 31.89
|
-12.2 percentage change
Standard Deviation 40.59
|
-0.7 percentage change
Standard Deviation 42.98
|
|
Mean Percentage Change From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Final Visit
|
9.0 percentage change
Standard Deviation 46.63
|
-35.6 percentage change
Standard Deviation 30.81
|
20.0 percentage change
Standard Deviation 31.73
|
-2.7 percentage change
Standard Deviation 46.63
|
3.0 percentage change
Standard Deviation 28.7
|
-34.8 percentage change
Standard Deviation 30.36
|
-12.8 percentage change
Standard Deviation 39.65
|
0.0 percentage change
Standard Deviation 40.17
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound.
Outcome measures
| Measure |
Cohort 1: Placebo
n=65 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Month 3
|
7.3 percentage change
Standard Deviation 25.12
|
-30.9 percentage change
Standard Deviation 28.87
|
-19.4 percentage change
Standard Deviation 22.48
|
-7.3 percentage change
Standard Deviation 20.7
|
8.4 percentage change
Standard Deviation 24.26
|
-24.7 percentage change
Standard Deviation 21.98
|
-15.7 percentage change
Standard Deviation 21.84
|
-6.1 percentage change
Standard Deviation 18.81
|
|
Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Month 6
|
17.5 percentage change
Standard Deviation 40.25
|
-35.6 percentage change
Standard Deviation 25.74
|
-21.9 percentage change
Standard Deviation 27.64
|
-13.2 percentage change
Standard Deviation 23.86
|
10.7 percentage change
Standard Deviation 20.73
|
-26.00 percentage change
Standard Deviation 29.51
|
-13.5 percentage change
Standard Deviation 25.09
|
-9.0 percentage change
Standard Deviation 22.12
|
|
Mean Percentage Change From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Final Visit
|
15.9 percentage change
Standard Deviation 38.06
|
-31.5 percentage change
Standard Deviation 31.44
|
-22.0 percentage change
Standard Deviation 28.52
|
-11.8 percentage change
Standard Deviation 22.56
|
11.6 percentage change
Standard Deviation 25.38
|
-26.6 percentage change
Standard Deviation 28.26
|
-11.5 percentage change
Standard Deviation 25.33
|
-6.7 percentage change
Standard Deviation 21.8
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound.
Outcome measures
| Measure |
Cohort 1: Placebo
n=65 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Month 3
|
13.2 percentage of participants
|
79.6 percentage of participants
|
50.0 percentage of participants
|
31.9 percentage of participants
|
9.4 percentage of participants
|
66.7 percentage of participants
|
34.0 percentage of participants
|
22.4 percentage of participants
|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Month 6
|
24.4 percentage of participants
|
75.0 percentage of participants
|
54.2 percentage of participants
|
40.5 percentage of participants
|
18.2 percentage of participants
|
62.0 percentage of participants
|
40.9 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Total Fibroid Volume at Month 3, Month 6, and Final Visit
Final Visit
|
24.5 percentage of participants
|
73.6 percentage of participants
|
57.4 percentage of participants
|
41.2 percentage of participants
|
16.7 percentage of participants
|
64.4 percentage of participants
|
40.0 percentage of participants
|
30.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound.
Outcome measures
| Measure |
Cohort 1: Placebo
n=65 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Final Visit
|
24.5 percentage of participants
|
69.8 percentage of participants
|
50.0 percentage of participants
|
27.5 percentage of participants
|
13.6 percentage of participants
|
66.1 percentage of participants
|
40.0 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Month 3
|
13.2 percentage of participants
|
67.3 percentage of participants
|
46.2 percentage of participants
|
23.4 percentage of participants
|
10.9 percentage of participants
|
63.2 percentage of participants
|
37.7 percentage of participants
|
22.4 percentage of participants
|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Primary Fibroid Volume at Month 3, Month 6, and Final Visit
Month 6
|
24.4 percentage of participants
|
70.5 percentage of participants
|
47.9 percentage of participants
|
26.2 percentage of participants
|
14.5 percentage of participants
|
64.0 percentage of participants
|
38.6 percentage of participants
|
34.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound.
Outcome measures
| Measure |
Cohort 1: Placebo
n=65 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Month 3
|
5.2 percentage of participants
|
73.1 percentage of participants
|
42.9 percentage of participants
|
18.5 percentage of participants
|
1.4 percentage of participants
|
57.1 percentage of participants
|
36.8 percentage of participants
|
17.5 percentage of participants
|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Month 6
|
2.0 percentage of participants
|
78.7 percentage of participants
|
58.0 percentage of participants
|
31.9 percentage of participants
|
1.6 percentage of participants
|
62.5 percentage of participants
|
32.7 percentage of participants
|
26.0 percentage of participants
|
|
Percentage of Participants With ≥ 25% Reduction From Baseline in Uterine Volume at Month 3, Month 6, and Final Visit
Final Visit
|
3.4 percentage of participants
|
73.2 percentage of participants
|
58.9 percentage of participants
|
26.8 percentage of participants
|
1.4 percentage of participants
|
63.1 percentage of participants
|
29.3 percentage of participants
|
23.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168Population: Modified ITT: randomized participants who received at least 1 dose of randomized, double-blind study drug in this study. Participants with an assessment at baseline and given time point.
The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug.
Outcome measures
| Measure |
Cohort 1: Placebo
n=65 Participants
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 Participants
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 Participants
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 Participants
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 Participants
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 Participants
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 Participants
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 Participants
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
Final Month
|
-5.3 units on a scale
Standard Error 13.19
|
-6.7 units on a scale
Standard Error 11.94
|
-4.1 units on a scale
Standard Error 10.15
|
-3.5 units on a scale
Standard Error 12.59
|
-0.8 units on a scale
Standard Error 11.34
|
-4.0 units on a scale
Standard Error 9.40
|
-3.3 units on a scale
Standard Error 8.09
|
-2.3 units on a scale
Standard Error 10.56
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
PT Days 29-56
|
-5.7 units on a scale
Standard Error 15.83
|
-4.1 units on a scale
Standard Error 13.1
|
-1.0 units on a scale
Standard Error 11.57
|
0.0 units on a scale
Standard Error 9.89
|
-0.2 units on a scale
Standard Error 12.49
|
-2.8 units on a scale
Standard Error 11.85
|
-2.7 units on a scale
Standard Error 7.58
|
-2.5 units on a scale
Standard Error 8.54
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
PT Days 57-84
|
-5.4 units on a scale
Standard Error 17.08
|
-4.0 units on a scale
Standard Error 14.11
|
-2.1 units on a scale
Standard Error 10.91
|
-1.1 units on a scale
Standard Error 10.50
|
-0.5 units on a scale
Standard Error 13.08
|
-2.0 units on a scale
Standard Error 9.79
|
-1.6 units on a scale
Standard Error 8.35
|
-3.9 units on a scale
Standard Error 6.87
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
PT Days 85-112
|
-4.4 units on a scale
Standard Error 17.82
|
-6.4 units on a scale
Standard Error 12.99
|
-4.8 units on a scale
Standard Error 10.33
|
0.7 units on a scale
Standard Error 6.59
|
-2.7 units on a scale
Standard Error 7.15
|
-2.4 units on a scale
Standard Error 14.37
|
-3.0 units on a scale
Standard Error 7.48
|
-5.0 units on a scale
Standard Error 5.12
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
PT Days 113-140
|
3.4 units on a scale
Standard Error 27.8
|
-3.1 units on a scale
Standard Error 2.15
|
1.3 units on a scale
Standard Error NA
only 1 participant analyzed
|
1.4 units on a scale
Standard Error 1.75
|
-6.2 units on a scale
Standard Error 1.51
|
-17.3 units on a scale
Standard Error 26.2
|
-5.6 units on a scale
Standard Error 6.45
|
-7.0 units on a scale
Standard Error 7.12
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
Days 1-28
|
-3.3 units on a scale
Standard Error 10.11
|
-3.4 units on a scale
Standard Error 8.21
|
-3.1 units on a scale
Standard Error 7.88
|
-1.4 units on a scale
Standard Error 6.42
|
0.4 units on a scale
Standard Error 4.71
|
-2.7 units on a scale
Standard Error 7.27
|
-2.1 units on a scale
Standard Error 4.44
|
0.0 units on a scale
Standard Error 6.26
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
Days 29-56
|
-4.5 units on a scale
Standard Error 13.12
|
-5.8 units on a scale
Standard Error 8.78
|
-4.4 units on a scale
Standard Error 6.59
|
-2.9 units on a scale
Standard Error 9.44
|
-0.3 units on a scale
Standard Error 7.13
|
-4.2 units on a scale
Standard Error 7.72
|
-2.2 units on a scale
Standard Error 5.54
|
-2.3 units on a scale
Standard Error 9.31
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
Days 57-84
|
-5.6 units on a scale
Standard Error 10.94
|
-7.2 units on a scale
Standard Error 11.04
|
-4.1 units on a scale
Standard Error 8.4
|
-3.2 units on a scale
Standard Error 11.26
|
0.1 units on a scale
Standard Error 7.34
|
-4.5 units on a scale
Standard Error 8.55
|
-2.2 units on a scale
Standard Error 6.22
|
-3.8 units on a scale
Standard Error 8.92
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
Days 85-112
|
-7.0 units on a scale
Standard Error 10.74
|
-7.8 units on a scale
Standard Error 11.75
|
-5.2 units on a scale
Standard Error 9.05
|
-3.7 units on a scale
Standard Error 10.76
|
-0.2 units on a scale
Standard Error 7.47
|
-5.1 units on a scale
Standard Error 9.40
|
-3.6 units on a scale
Standard Error 7.35
|
-4.1 units on a scale
Standard Error 8.96
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
Days 113-140
|
-4.1 units on a scale
Standard Error 13.16
|
-7.6 units on a scale
Standard Error 12.03
|
-5.3 units on a scale
Standard Error 9.43
|
-3.4 units on a scale
Standard Error 12.1
|
0.1 units on a scale
Standard Error 11.92
|
-5.5 units on a scale
Standard Error 8.44
|
-4.0 units on a scale
Standard Error 8.13
|
-5.3 units on a scale
Standard Error 8.99
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
Days 141-168
|
-6.8 units on a scale
Standard Error 14.28
|
-8.0 units on a scale
Standard Error 12.65
|
-5.1 units on a scale
Standard Error 9.94
|
-3.3 units on a scale
Standard Error 13.01
|
-0.4 units on a scale
Standard Error 10.46
|
-5.9 units on a scale
Standard Error 9.45
|
-4.4 units on a scale
Standard Error 8.21
|
-4.8 units on a scale
Standard Error 9.3
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
PT Days 1-28
|
-5.6 units on a scale
Standard Error 13.39
|
-5.2 units on a scale
Standard Error 12.13
|
-3.8 units on a scale
Standard Error 10.37
|
-3.0 units on a scale
Standard Error 10.69
|
-0.8 units on a scale
Standard Error 12.46
|
-3.8 units on a scale
Standard Error 10.53
|
-2.0 units on a scale
Standard Error 8.23
|
-2.3 units on a scale
Standard Error 7.82
|
|
Change From Baseline to Each Month in Non-Bleeding Uterine Fibroids Symptom (NBUFSQ) Questionnaire
PT Days 141-168
|
7.5 units on a scale
Standard Error 27.75
|
-8.0 units on a scale
Standard Error 1.42
|
4.1 units on a scale
Standard Error NA
only 1 participant analyzed
|
-3.3 units on a scale
Standard Error NA
only 1 participant analyzed
|
-10.5 units on a scale
Standard Error NA
only 1 participant analyzed
|
-3.1 units on a scale
Standard Error NA
only 1 participant analyzed
|
-3.3 units on a scale
Standard Error 6.42
|
-6.4 units on a scale
Standard Error 5.94
|
SECONDARY outcome
Timeframe: Month 6Population: This endpoint was not completed due to lack of data collection.
The percentage of participants who successfully avoided surgical or invasive procedures for Uterine Fibroids was assessed.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1: Placebo
Serious events: 6 serious events
Other events: 33 other events
Deaths: 0 deaths
Cohort 1: Elagolix 300 mg BID
Serious events: 3 serious events
Other events: 45 other events
Deaths: 0 deaths
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
Serious events: 3 serious events
Other events: 37 other events
Deaths: 0 deaths
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Cohort 2: Placebo
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Cohort 2: Elagolix 600 mg QD
Serious events: 5 serious events
Other events: 59 other events
Deaths: 0 deaths
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1: Placebo
n=65 participants at risk
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 participants at risk
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 participants at risk
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 participants at risk
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 participants at risk
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 participants at risk
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 participants at risk
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 participants at risk
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/78 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
PNEUMONIA
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
VARICELLA
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Injury, poisoning and procedural complications
MENISCUS INJURY
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL ADENOCARCINOMA
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRINOMA MALIGNANT
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
Other adverse events
| Measure |
Cohort 1: Placebo
n=65 participants at risk
Placebo for elagolix BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID
n=65 participants at risk
Elagolix 300 mg BID and placebo for E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD
n=64 participants at risk
Elagolix 300 mg BID plus LD E2/NETA QD
|
Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD
n=65 participants at risk
Elagolix 300 mg BID plus SD E2/NETA QD
|
Cohort 2: Placebo
n=78 participants at risk
Placebo for elagolix QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD
n=77 participants at risk
Elagolix 600 mg QD and placebo for E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD
n=76 participants at risk
Elagolix 600 mg QD plus LD E2/NETA QD
|
Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD
n=77 participants at risk
Elagolix 600 mg QD plus SD E2/NETA QD
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
9.2%
6/65 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/64 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.7%
6/78 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/77 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.9%
6/76 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.8%
3/78 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.8%
6/77 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/77 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/64 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/77 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/76 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Gastrointestinal disorders
DIARRHOEA
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/64 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.7%
5/65 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.1%
4/78 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/76 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Gastrointestinal disorders
NAUSEA
|
9.2%
6/65 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/64 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
18.5%
12/65 • Number of events 13 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.8%
3/78 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
13.0%
10/77 • Number of events 11 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
15.8%
12/76 • Number of events 12 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
26.0%
20/77 • Number of events 23 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Gastrointestinal disorders
VOMITING
|
1.5%
1/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.1%
4/78 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/76 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 7 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
General disorders
FATIGUE
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/64 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.8%
3/78 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
BACTERIAL VAGINOSIS
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/64 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/64 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/78 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/76 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/64 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.4%
5/78 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/76 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.5%
1/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/76 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
URINARY TRACT INFECTION
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.8%
5/64 • Number of events 7 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.4%
5/78 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/76 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Infections and infestations
VULVOVAGINAL MYCOTIC INFECTION
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/64 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Investigations
BLOOD CHOLESTEROL INCREASED
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.3%
4/76 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Investigations
BONE DENSITY DECREASED
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.7%
5/65 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/64 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Investigations
LIPIDS INCREASED
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/64 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.8%
6/77 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.7%
3/64 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.8%
3/78 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.3%
4/76 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
9.2%
6/65 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.7%
5/65 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/64 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.8%
6/77 • Number of events 7 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.9%
6/76 • Number of events 7 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
9.1%
7/77 • Number of events 7 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/77 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/77 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/76 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/64 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Nervous system disorders
DIZZINESS
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.8%
3/78 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/77 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.3%
4/76 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Nervous system disorders
HEADACHE
|
9.2%
6/65 • Number of events 7 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
12.3%
8/65 • Number of events 8 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
14.1%
9/64 • Number of events 9 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
20.0%
13/65 • Number of events 14 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
10.3%
8/78 • Number of events 9 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
16.9%
13/77 • Number of events 15 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
14.5%
11/76 • Number of events 11 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
18.2%
14/77 • Number of events 14 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Psychiatric disorders
INSOMNIA
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
10.8%
7/65 • Number of events 7 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.8%
5/64 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.2%
4/77 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/76 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/77 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.6%
5/76 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.9%
3/77 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.7%
3/64 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.2%
4/65 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/78 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/76 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
9.1%
7/77 • Number of events 8 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/65 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/78 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/77 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/76 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Vascular disorders
HOT FLUSH
|
3.1%
2/65 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
44.6%
29/65 • Number of events 32 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
25.0%
16/64 • Number of events 16 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
10.8%
7/65 • Number of events 7 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
5.1%
4/78 • Number of events 4 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
49.4%
38/77 • Number of events 39 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
18.4%
14/76 • Number of events 14 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
14.3%
11/77 • Number of events 11 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
|
Vascular disorders
HYPERTENSION
|
4.6%
3/65 • Number of events 3 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.5%
1/65 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.6%
1/64 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
7.7%
5/65 • Number of events 5 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
0.00%
0/78 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
6.5%
5/77 • Number of events 6 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
2.6%
2/76 • Number of events 2 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
1.3%
1/77 • Number of events 1 • From the time of study drug administration through Final Visit (Month 6 or early termination) plus 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER