Trial Outcomes & Findings for Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (NCT NCT02654054)
NCT ID: NCT02654054
Last Updated: 2020-06-29
Results Overview
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period \[last treatment visit date\] or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
413 participants
Primary outcome timeframe
Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
Results posted on
2020-06-29
Participant Flow
Eligible participants were randomized in a 1:1:2 ratio to 1 of 3 treatment groups: placebo, elagolix 300 mg BID, or elagolix 300 mg twice daily (BID) plus estradiol/norethindrone acetate (E2/NETA) once daily (QD).
Participant milestones
| Measure |
Placebo
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Treatment Period
STARTED
|
102
|
104
|
207
|
|
Treatment Period
Randomized and Treated
|
102
|
104
|
206
|
|
Treatment Period
COMPLETED
|
83
|
81
|
164
|
|
Treatment Period
NOT COMPLETED
|
19
|
23
|
43
|
|
Post-Treatment Follow-Up Period
STARTED
|
25
|
32
|
59
|
|
Post-Treatment Follow-Up Period
COMPLETED
|
17
|
24
|
29
|
|
Post-Treatment Follow-Up Period
NOT COMPLETED
|
8
|
8
|
30
|
Reasons for withdrawal
| Measure |
Placebo
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Post-Treatment Follow-Up Period
Withdrawal by Subject
|
2
|
6
|
7
|
|
Post-Treatment Follow-Up Period
Lost to Follow-up
|
3
|
0
|
13
|
|
Post-Treatment Follow-Up Period
Required Surgery/Invasive Intervention
|
2
|
2
|
2
|
|
Post-Treatment Follow-Up Period
Other
|
1
|
0
|
4
|
|
Post-Treatment Follow-Up Period
Non-Compliance
|
0
|
0
|
4
|
Baseline Characteristics
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Baseline characteristics by cohort
| Measure |
Placebo
n=102 Participants
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=104 Participants
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
n=206 Participants
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 5.68 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 5.16 • n=7 Participants
|
42.6 years
STANDARD_DEVIATION 5.30 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 5.37 • n=4 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
412 Participants
n=4 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
355 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
70 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
280 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6Population: All randomized and treated participants.
Percentage of responders, defined as participants who met the following conditions: * Menstrual blood loss (MBL) volume \< 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period \[last treatment visit date\] or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and * ≥ 50% reduction in MBL volume from Baseline to the Final Month. Participants who prematurely discontinued study drug due to "lack of efficacy," "requires surgery or invasive intervention for treatment of uterine fibroids," or "adverse events" were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not.
Outcome measures
| Measure |
Placebo
n=102 Participants
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=104 Participants
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
n=206 Participants
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Percentage of Participants Meeting the Criteria for Responder
|
8.7 percentage of participants
|
84.1 percentage of participants
|
68.5 percentage of participants
|
SECONDARY outcome
Timeframe: Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6Population: All randomized and treated participants.
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.
Outcome measures
| Measure |
Placebo
n=102 Participants
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=104 Participants
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
n=206 Participants
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Change From Baseline in MBL Volume to the Final Month
|
0.8 mL
Standard Error 14.86
|
-221.5 mL
Standard Error 14.49
|
-176.7 mL
Standard Error 10.40
|
SECONDARY outcome
Timeframe: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6Population: All randomized and treated participants with an assessment
Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11. The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date.
Outcome measures
| Measure |
Placebo
n=91 Participants
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=94 Participants
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
n=183 Participants
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Percentage of Participants With Suppression of Bleeding at the Final Month
|
4.4 percentage of participants
|
84.0 percentage of participants
|
56.8 percentage of participants
|
SECONDARY outcome
Timeframe: Month 0 (Baseline), Month 6Population: All randomized and treated participants with an assessment at given time point.
Outcome measures
| Measure |
Placebo
n=71 Participants
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=67 Participants
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
n=132 Participants
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Change From Baseline in MBL Volume to Month 6
|
-2.3 mL
Standard Error 13.53
|
-236.2 mL
Standard Error 13.74
|
-194.7 mL
Standard Error 9.77
|
SECONDARY outcome
Timeframe: Month 0 (Baseline), Month 3Population: All randomized and treated participants with an assessment at given time point.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=83 Participants
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
n=172 Participants
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Change From Baseline in MBL Volume to Month 3
|
6.1 mL
Standard Error 15.32
|
-234.7 mL
Standard Error 15.38
|
-192.2 mL
Standard Error 10.81
|
SECONDARY outcome
Timeframe: Month 0 (Baseline), Month 6Population: All randomized and treated participants with baseline hemoglobin \<= 10.5 g/dL and an assessment at Month 6.
Outcome measures
| Measure |
Placebo
n=31 Participants
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=41 Participants
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
n=52 Participants
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6
|
16.1 percentage of participants
|
65.9 percentage of participants
|
61.5 percentage of participants
|
SECONDARY outcome
Timeframe: Month 0 (Baseline), Month 1Population: All randomized and treated participants with an assessment at given time point.
Outcome measures
| Measure |
Placebo
n=95 Participants
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=97 Participants
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2/NETA
n=187 Participants
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Change From Baseline in MBL Volume to Month 1
|
-19.0 mL
Standard Error 16.05
|
-209.0 mL
Standard Error 15.91
|
-135.2 mL
Standard Error 11.41
|
Adverse Events
Placebo
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Elagolix
Serious events: 3 serious events
Other events: 81 other events
Deaths: 0 deaths
Elagolix + E2-NETA
Serious events: 3 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=102 participants at risk
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=104 participants at risk
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2-NETA
n=206 participants at risk
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.0%
2/102 • Number of events 2 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
General disorders
PROLAPSE
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.96%
1/104 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.98%
1/102 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.49%
1/206 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.49%
1/206 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.98%
1/102 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
1.9%
2/104 • Number of events 2 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.96%
1/104 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Pregnancy, puerperium and perinatal conditions
ECTOPIC PREGNANCY
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.96%
1/104 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.98%
1/102 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.98%
1/102 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.96%
1/104 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.98%
1/102 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/206 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.49%
1/206 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Skin and subcutaneous tissue disorders
PALMOPLANTAR KERATODERMA
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.00%
0/104 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.49%
1/206 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
Other adverse events
| Measure |
Placebo
n=102 participants at risk
Placebo for both elagolix BID and E2/NETA QD
|
Elagolix
n=104 participants at risk
Elagolix 300 mg BID and placebo for E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
Elagolix + E2-NETA
n=206 participants at risk
Elagolix 300 mg BID and E2/NETA (estradiol 1.0 mg/norethindrone acetate 0.5 mg) QD
|
|---|---|---|---|
|
Gastrointestinal disorders
NAUSEA
|
9.8%
10/102 • Number of events 10 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
6.7%
7/104 • Number of events 7 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
11.2%
23/206 • Number of events 26 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
General disorders
FATIGUE
|
2.0%
2/102 • Number of events 2 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.96%
1/104 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
6.8%
14/206 • Number of events 14 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Infections and infestations
NASOPHARYNGITIS
|
3.9%
4/102 • Number of events 5 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
5.8%
6/104 • Number of events 6 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
4.9%
10/206 • Number of events 12 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Nervous system disorders
HEADACHE
|
8.8%
9/102 • Number of events 11 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
16.3%
17/104 • Number of events 20 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
8.3%
17/206 • Number of events 18 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Psychiatric disorders
INSOMNIA
|
5.9%
6/102 • Number of events 6 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
6.7%
7/104 • Number of events 7 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
2.4%
5/206 • Number of events 5 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Psychiatric disorders
MOOD SWINGS
|
2.0%
2/102 • Number of events 2 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
6.7%
7/104 • Number of events 7 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
3.9%
8/206 • Number of events 8 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
3.9%
4/102 • Number of events 4 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.96%
1/104 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
6.3%
13/206 • Number of events 13 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/102 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
0.96%
1/104 • Number of events 1 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
6.3%
13/206 • Number of events 13 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
2.9%
3/102 • Number of events 3 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
26.9%
28/104 • Number of events 31 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
6.8%
14/206 • Number of events 15 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
|
Vascular disorders
HOT FLUSH
|
8.8%
9/102 • Number of events 10 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
64.4%
67/104 • Number of events 72 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
20.4%
42/206 • Number of events 44 • From first dose of study drug through 6 months of treatment with a 30-day follow-up period for participants who did not enroll in the extension study (Study M12-816). Mean (SD) treatment exposure was 158.6 (50.10), 161.2 (51.45), and 159.9 (53.48) days for the Placebo, Elagolix, and Elagolix and E2-NETA arms, respectively.
Treatment-emergent adverse events are presented.
|
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