Trial · NCT02654054

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

NCT02654054, Phase 3, Completed, AbbVie; results first posted 2020-06-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02654054. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02654054

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT02654054
Status: Completed
Phases: Phase 3
Enrollment: 413 participants, actual
Lead sponsor: AbbVie
Conditions: Uterine Fibroids, Heavy Menstrual Bleeding
Interventions: Elagolix, Placebo for Estradiol/Norethindrone Acetate, Estradiol/Norethindrone Acetate, Placebo for Elagolix
First posted: 2016-01-13
Last updated: 2020-06-29
Results first posted: 2020-06-29

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants Meeting the Criteria for Responder	Final Month (the last 28 days prior to and including the Reference Day), up to Month 6	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.
Secondary	Change From Baseline in MBL Volume to the Final Month	Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6	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.
Secondary	Percentage of Participants With Suppression of Bleeding at the Final Month	Final Month (the last 28 days prior to and including the Reference Day), up to Month 6	Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11. 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.
Secondary	Change From Baseline in MBL Volume to Month 6	Month 0 (Baseline), Month 6
Secondary	Change From Baseline in MBL Volume to Month 3	Month 0 (Baseline), Month 3
Secondary	Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6	Month 0 (Baseline), Month 6
Secondary	Change From Baseline in MBL Volume to Month 1	Month 0 (Baseline), Month 1

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Meeting the Criteria for Responder	Final Month (the last 28 days prior to and including the Reference Day), up to Month 6	All randomized and treated participants.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in MBL Volume to the Final Month	Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6	All randomized and treated participants.	mL	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Suppression of Bleeding at the Final Month	Final Month (the last 28 days prior to and including the Reference Day), up to Month 6	All randomized and treated participants with an assessment	percentage of participants	NUMBER
SECONDARY	Change From Baseline in MBL Volume to Month 6	Month 0 (Baseline), Month 6	All randomized and treated participants with an assessment at given time point.	mL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in MBL Volume to Month 3	Month 0 (Baseline), Month 3	All randomized and treated participants with an assessment at given time point.	mL	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Baseline Hemoglobin <= 10.5 g/dL Who Have an Increase in Hemoglobin > 2 g/dL at Month 6	Month 0 (Baseline), Month 6	All randomized and treated participants with baseline hemoglobin \<= 10.5 g/dL and an assessment at Month 6.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in MBL Volume to Month 1	Month 0 (Baseline), Month 1	All randomized and treated participants with an assessment at given time point.	mL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group21

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants Meeting the Criteria for Responder	Placebo	8.7		percentage of participants
Percentage of Participants Meeting the Criteria for Responder	Elagolix	84.1		percentage of participants
Percentage of Participants Meeting the Criteria for Responder	Elagolix + E2/NETA	68.5		percentage of participants
Change From Baseline in MBL Volume to the Final Month	Placebo	0.8	Standard Error 14.86	mL
Change From Baseline in MBL Volume to the Final Month	Elagolix	-221.5	Standard Error 14.49	mL
Change From Baseline in MBL Volume to the Final Month	Elagolix + E2/NETA	-176.7	Standard Error 10.40	mL
Percentage of Participants With Suppression of Bleeding at the Final Month	Placebo	4.4		percentage of participants
Percentage of Participants With Suppression of Bleeding at the Final Month	Elagolix	84.0		percentage of participants
Percentage of Participants With Suppression of Bleeding at the Final Month	Elagolix + E2/NETA	56.8		percentage of participants
Change From Baseline in MBL Volume to Month 6	Placebo	-2.3	Standard Error 13.53	mL

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow21

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Treatment Period	STARTED	Placebo	102
Treatment Period	STARTED	Elagolix	104
Treatment Period	STARTED	Elagolix + E2/NETA	207
Treatment Period	Randomized and Treated	Placebo	102
Treatment Period	Randomized and Treated	Elagolix	104
Treatment Period	Randomized and Treated	Elagolix + E2/NETA	206
Treatment Period	COMPLETED	Placebo	83
Treatment Period	COMPLETED	Elagolix	81
Treatment Period	COMPLETED	Elagolix + E2/NETA	164
Treatment Period	NOT COMPLETED	Placebo	19

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	NAUSEA	Gastrointestinal disorders	Placebo	10	102	10
other	NAUSEA	Gastrointestinal disorders	Elagolix	7	104	7
other	NAUSEA	Gastrointestinal disorders	Elagolix + E2-NETA	23	206	26
other	FATIGUE	General disorders	Placebo	2	102	2
other	FATIGUE	General disorders	Elagolix	1	104	1
other	FATIGUE	General disorders	Elagolix + E2-NETA	14	206	14
other	NASOPHARYNGITIS	Infections and infestations	Placebo	4	102	5
other	NASOPHARYNGITIS	Infections and infestations	Elagolix	6	104	6
other	NASOPHARYNGITIS	Infections and infestations	Elagolix + E2-NETA	10	206	12
other	HEADACHE	Nervous system disorders	Placebo	9	102	11

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	102
Total, all-cause mortality	Elagolix	0	104
Total, all-cause mortality	Elagolix + E2-NETA	0	206
Total, other adverse events	Placebo	29	102
Total, other adverse events	Elagolix	81	104
Total, other adverse events	Elagolix + E2-NETA	96	206
Total, serious adverse events	Placebo	5	102
Total, serious adverse events	Elagolix	3	104
Total, serious adverse events	Elagolix + E2-NETA	3	206

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
31971678	DERIVED	PubMed
32702363	DERIVED	PubMed
33650259	DERIVED	PubMed
34553161	DERIVED	PubMed
34582715	DERIVED	PubMed
34878624	DERIVED	PubMed
39381651	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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