Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (NCT NCT03886220)
NCT ID: NCT03886220
Last Updated: 2022-03-31
Results Overview
Responders were defined as participants meeting the following 2 conditions: * menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and * 50% or greater reduction in MBL volume from Baseline to the Final Month. Participants whose primary reason for prematurely discontinuing study drug was "lack of efficacy," or "requires surgery or invasive intervention for treatment of uterine fibroids" were considered as non-responders. MBL was measured by the alkaline hematin method.
COMPLETED
PHASE4
82 participants
From Month 0 (Baseline) to Final Month (up to Month 6)
2022-03-31
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo once daily (QD)
|
Elagolix 150 mg
Elagolix 150 mg QD
|
|---|---|---|
|
Treatment Period
STARTED
|
28
|
54
|
|
Treatment Period
COMPLETED
|
23
|
42
|
|
Treatment Period
NOT COMPLETED
|
5
|
12
|
|
Post-Treatment Follow-Up Period
STARTED
|
25
|
41
|
|
Post-Treatment Follow-Up Period
COMPLETED
|
23
|
39
|
|
Post-Treatment Follow-Up Period
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Placebo once daily (QD)
|
Elagolix 150 mg
Elagolix 150 mg QD
|
|---|---|---|
|
Treatment Period
Discontinued study drug during the treatment period
|
5
|
12
|
|
Post-Treatment Follow-Up Period
Withdrawal by Subject
|
1
|
0
|
|
Post-Treatment Follow-Up Period
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
Placebo QD
|
Elagolix 150 mg
n=54 Participants
Elagolix 150 mg QD
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 3.82 • n=99 Participants
|
42.0 years
STANDARD_DEVIATION 5.02 • n=107 Participants
|
42.3 years
STANDARD_DEVIATION 4.65 • n=206 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
17 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From Month 0 (Baseline) to Final Month (up to Month 6)Population: Full Analysis Set; multiple imputation.
Responders were defined as participants meeting the following 2 conditions: * menstrual blood loss (MBL) volume \< 80 mL at the Final Month (defined as the last 28 days prior to and including the last dose day), and * 50% or greater reduction in MBL volume from Baseline to the Final Month. Participants whose primary reason for prematurely discontinuing study drug was "lack of efficacy," or "requires surgery or invasive intervention for treatment of uterine fibroids" were considered as non-responders. MBL was measured by the alkaline hematin method.
Outcome measures
| Measure |
Placebo
n=28 Participants
Placebo QD
|
Elagolix 150 mg
n=54 Participants
Elagolix 150 mg QD
|
|---|---|---|
|
Percentage of Participants Who Were Responders With Menstrual Blood Loss (MBL) Volume < 80 mL at Final Month and >= 50% Reduction in MBL Volume From Baseline to the Final Month
|
23.3 percentage of participants
Interval 7.16 to 39.5
|
49.4 percentage of participants
Interval 35.06 to 63.83
|
Adverse Events
Placebo
Elagolix 150 mg
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Placebo QD
|
Elagolix 150 mg
n=54 participants at risk
Elagolix 150 mg QD
|
|---|---|---|
|
Gastrointestinal disorders
ENLARGED UVULA
|
3.6%
1/28 • Number of events 1 • All-cause mortality: median of 197 days. Serious adverse events/other adverse events: from first dose of study drug through Month 7.
|
0.00%
0/54 • All-cause mortality: median of 197 days. Serious adverse events/other adverse events: from first dose of study drug through Month 7.
|
|
Infections and infestations
COVID-19
|
3.6%
1/28 • Number of events 1 • All-cause mortality: median of 197 days. Serious adverse events/other adverse events: from first dose of study drug through Month 7.
|
0.00%
0/54 • All-cause mortality: median of 197 days. Serious adverse events/other adverse events: from first dose of study drug through Month 7.
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Placebo QD
|
Elagolix 150 mg
n=54 participants at risk
Elagolix 150 mg QD
|
|---|---|---|
|
Nervous system disorders
HEADACHE
|
3.6%
1/28 • Number of events 1 • All-cause mortality: median of 197 days. Serious adverse events/other adverse events: from first dose of study drug through Month 7.
|
13.0%
7/54 • Number of events 7 • All-cause mortality: median of 197 days. Serious adverse events/other adverse events: from first dose of study drug through Month 7.
|
|
Vascular disorders
HOT FLUSH
|
3.6%
1/28 • Number of events 1 • All-cause mortality: median of 197 days. Serious adverse events/other adverse events: from first dose of study drug through Month 7.
|
11.1%
6/54 • Number of events 6 • All-cause mortality: median of 197 days. Serious adverse events/other adverse events: from first dose of study drug through Month 7.
|
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