NCT03343067 is a Phase 3 clinical trial of elagolix in Endometriosis, sponsored by AbbVie.

Who is sponsoring NCT03343067?

NCT03343067 is sponsored by AbbVie.

What drugs are being tested in NCT03343067?

Interventions in NCT03343067: elagolix, estradiol/norethindrone acetate (E2/NETA).

What condition does NCT03343067 study?

NCT03343067 studies Endometriosis.

Is NCT03343067 still recruiting?

NCT03343067 is currently terminated. Last updated 27 November 2019.

Are results published for NCT03343067?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-27 · How we verify

NCT03343067

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain

Terminated Phase 3 Results posted Last updated 27 November 2019

What this trial tests

Phase 3 trial testing elagolix in Endometriosis in 11 participants. Terminated before completion.

Timeline

27 December 2017

Primary endpoint
23 October 2018

23 October 2018

Quick facts

Lead sponsor	AbbVie
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	11
Start date	27 December 2017
Primary completion	23 October 2018
Estimated completion	23 October 2018
Sites	37 locations across United States

Drugs / interventions tested

elagolix (ELAGOLIX) — full drug profile →
estradiol/norethindrone acetate (E2/NETA)

Conditions studied

Endometriosis — all drugs for Endometriosis →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 49, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in DYS at Month 6 Secondary · Month 0 (baseline), Month 6

Group	Value	95% CI
Group B	-0.23	± NA

Change From Baseline in NMPP at Month 6 Secondary · Month 0 (baseline), Month 6

The NMPP pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

Group	Value	95% CI
Group B	-0.13	± 0.061

Change From Baseline in Dyspareunia at Month 6 Secondary · Month 0 (baseline), Month 6

The dyspareunia pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

Group	Value	95% CI
Group B	0.29	± NA

Change From Baseline in Daily Diary Endometriosis-Associated Pain Score Via Numeric Rating Scale (NRS) at Month 6 Secondary · Month 0 (baseline), Month 6

The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement.

Group	Value	95% CI
Group B	-1.36	± 0.020

Change From Baseline in Rescue Analgesic Use Across Both Classes of Rescue Analgesics (NSAIDs/Opioids) at Month 6 Secondary · Month 0 (baseline), Month 6

Based on average pill counts and assessed using the daily e-Diary. Permitted non-steroidal anti-inflammatory drugs (NSAIDs) included naproxen, ibuprofen, diclofenac, and celecoxib. Permitted opioids included hydrocodone + acetaminophen and codeine phosphate + acetaminophen.

NSAID: Change at Month 6

Group	Value	95% CI
Group B	0.63	± 0.606

Opioid: Change at Month 6

Group	Value	95% CI
Group B	0.09	± 0.121

NSAID + Opioid: Change at Month 6

Group	Value	95% CI
Group B	0.71	± 0.485

Percentage of Participants With 30% or More Reduction From Baseline Based on the 35 Day Mean of the Daily Diary Endometriosis-Associated Pain Score Via NRS at Month 6 Secondary · Month 6

The NRS for overall endometriosis-associated pain ranges from 0 (none) to 10 (worst pain ever), recorded in a daily eDiary and averaged monthly based on a 35-day window.

Group	Value	95% CI
Group B	50.0

Change From Baseline Over Time in Monthly Average DYS Pain Score Secondary · Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

The DYS pain scale score ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe), recorded in a daily eDiary and averaged monthly based on a 35-day window. A negative change from baseline indicates improvement. The analysis was based on a 28-day window. If a participant prematurely discontinued during the open-label period, based on the analysis window, some data might fall into Month 4 analysis.

Change at Month 1

Group	Value	95% CI
Group A	0.05	± 0.655
Group B	-0.04	± NA

Change at Month 2

Group	Value	95% CI
Group A	-0.18	± 0.124
Group B	-0.26	± NA

Change at Month 3

Group	Value	95% CI
Group A	-0.50	± 0.263
Group B	-0.34	± NA

Change at Month 4

Group	Value	95% CI
Group A	-0.69	± NA
Group B	-0.06	± NA

Change at Month 5

Group	Value	95% CI
Group B	-0.16	± 0.141

Change at Month 6

Group	Value	95% CI
Group B	-0.23	± NA

Change From Baseline Over Time in Monthly Average NMPP Pain Score Secondary · Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Change at Month 1

Group	Value	95% CI
Group A	-0.13	± 0.252
Group B	-0.07	± 0.508
Group C	0.39	± NA

Change at Month 2

Group	Value	95% CI
Group A	-0.48	± 0.394
Group B	-0.30	± 0.167
Group C	0.29	± NA

Change at Month 3

Group	Value	95% CI
Group A	-0.70	± 0.828
Group B	-0.30	± 0.092
Group C	0.54	± NA

Change at Month 4

Group	Value	95% CI
Group A	-1.34	± NA
Group B	-0.34	± 0.029
Group C	0.46	± NA

Change at Month 5

Group	Value	95% CI
Group B	-0.27	± 0.256

Change at Month 6

Group	Value	95% CI
Group B	-0.13	± 0.061

Change From Baseline Over Time in Monthly Average Dyspareunia Pain Score Secondary · Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Change at Month 1

Group	Value	95% CI
Group A	-0.50	± 0.741
Group B	0.30	± NA
Group C	-0.29	± NA

Change at Month 2

Group	Value	95% CI
Group A	-1.44	± 1.071
Group B	0.06	± NA
Group C	-0.37	± NA

Change at Month 3

Group	Value	95% CI
Group A	-2.20	± NA
Group B	0.07	± 0.101
Group C	-0.03	± NA

Change at Month 4

Group	Value	95% CI
Group A	-2.23	± NA
Group B	0.09	± 0.040
Group C	-0.03	± NA

Change at Month 5

Group	Value	95% CI
Group B	0.09	± 0.081

Change at Month 6

Group	Value	95% CI
Group B	0.29	± NA

Change From Baseline Over Time in Monthly Average Daily Diary Endometriosis-Associated Pain Score Via NRS Secondary · Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Change at Month 1

Group	Value	95% CI
Group A	-0.86	± 1.975
Group B	-0.89	± 1.159
Group C	-0.84	± NA

Change at Month 2

Group	Value	95% CI
Group A	-2.40	± 2.106
Group B	-2.02	± 0.758
Group C	-1.40	± NA

Change at Month 3

Group	Value	95% CI
Group A	-3.70	± 3.616
Group B	-1.81	± 0.430
Group C	-1.34	± NA

Change at Month 4

Group	Value	95% CI
Group A	-6.43	± NA
Group B	-1.43	± 1.078
Group C	-1.06	± NA

Change at Month 5

Group	Value	95% CI
Group B	-1.40	± 0.961

Change at Month 6

Group	Value	95% CI
Group B	-1.36	± 0.020

Percent Change From Baseline to Each Month During the Treatment Period for DYS Secondary · Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Percent Change at Month 1

Group	Value	95% CI
Group A	1.67	± 109.961
Group B	-7.89	± NA

Percent Change at Month 2

Group	Value	95% CI
Group A	-27.45	± 17.119
Group B	-75.00	± NA

Percent Change at Month 3

Group	Value	95% CI
Group A	-62.92	± 24.159
Group B	-85.71	± NA

Percent Change at Month 4

Group	Value	95% CI
Group A	-80.00	± NA
Group B	-16.67	± NA

Percent Change at Month 5

Group	Value	95% CI
Group B	-40.48	± 33.672

Percent Change at Month 6

Group	Value	95% CI
Group B	-57.14	± NA

Percent Change From Baseline to Each Month During the Treatment Period for NMPP Secondary · Month 0 (baseline), Months 1, 2, 3, 4, 5, 6

Percent Change at Month 1

Group	Value	95% CI
Group A	-11.81	± 26.677
Group B	4.22	± 53.238
Group C	16.07	± NA

Percent Change at Month 2

Group	Value	95% CI
Group A	-37.53	± 31.150
Group B	-34.21	± 18.044
Group C	11.90	± NA

Percent Change at Month 3

Group	Value	95% CI
Group A	-38.26	± 42.319
Group B	-38.03	± 20.343
Group C	22.62	± NA

Percent Change at Month 4

Group	Value	95% CI
Group A	-71.21	± NA
Group B	-44.49	± 20.725
Group C	19.05	± NA

Percent Change at Month 5

Group	Value	95% CI
Group B	-28.40	± 33.641

Percent Change at Month 6

Group	Value	95% CI
Group B	-17.23	± 16.044

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to 6 months, plus 30 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group A

Serious: 0/7 (0%)

Deaths: 0/7

Group B

Serious: 0/3 (0%)

Deaths: 0/3

Group C

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (24 terms — click to expand)

Reaction	System	Group A	Group B	Group C
NAUSEA	Gastrointestinal disorders	—	—	—
EAR DISCOMFORT	Ear and labyrinth disorders	—	—	—
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	—	—	—
DIARRHOEA	Gastrointestinal disorders	—	—	—
VOMITING	Gastrointestinal disorders	—	—	—
CHILLS	General disorders	—	—	—
FATIGUE	General disorders	—	—	—
ANAPHYLACTIC REACTION	Immune system disorders	—	—	—
DRUG HYPERSENSITIVITY	Immune system disorders	—	—	—
GARDNERELLA INFECTION	Infections and infestations	—	—	—
ORAL HERPES	Infections and infestations	—	—	—
URINARY TRACT INFECTION	Infections and infestations	—	—	—
VAGINAL INFECTION	Infections and infestations	—	—	—
POLYDIPSIA	Metabolism and nutrition disorders	—	—	—
HEADACHE	Nervous system disorders	—	—	—
IRRITABILITY	Psychiatric disorders	—	—	—
ADNEXA UTERI PAIN	Reproductive system and breast disorders	—	—	—
DYSMENORRHOEA	Reproductive system and breast disorders	—	—	—
MENSTRUATION DELAYED	Reproductive system and breast disorders	—	—	—
PELVIC PAIN	Reproductive system and breast disorders	—	—	—
THROAT TIGHTNESS	Respiratory, thoracic and mediastinal disorders	—	—	—
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	—	—	—
NIGHT SWEATS	Skin and subcutaneous tissue disorders	—	—	—
HOT FLUSH	Vascular disorders	—	—	—

Data from ClinicalTrials.gov NCT03343067 adverse events section.

Sponsor's own description

This is a Phase 3, dose-escalation study designed to evaluate the safety and efficacy of both elagolix alone and elagolix plus estradiol/norethindrone acetate (E2/NETA) over 24 months in the management of endometriosis with associated moderate to severe pain in premenopausal women.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Hormonal treatments for endometriosis: The endocrine background.
Vannuccini S, Clemenza S, Rossi M, Petraglia F. · · 2022 · cited 168× · PMID 34405378 · DOI 10.1007/s11154-021-09666-w
Elagolix: First Global Approval.
Lamb YN. · · 2018 · cited 53× · PMID 30194661 · DOI 10.1007/s40265-018-0977-4
Endometriosis and pain in the adolescent- striking early to limit suffering: A narrative review.
Sieberg CB, Lunde CE, Borsook D. · · 2020 · cited 29× · PMID 31862211 · DOI 10.1016/j.neubiorev.2019.12.004
Elagolix in the treatment of endometriosis: impact beyond pain symptoms.
Archer DF, Soliman AM, Agarwal SK, Taylor HS. · · 2020 · cited 7× · PMID 33294846 · DOI 10.1177/2633494120964517
Molecular Targets for Endometriosis Therapy: Where We Are and Where We Are Going?
Barra F, Laganà AS, Casarin J, Ghezzi F, et al · · 2019 · cited 5× · PMID 31037916 · DOI 10.22074/ijfs.2019.5736

Verify or expand the search:

Other trials of elagolix

Trials testing the same drug.

NCT01620528 — A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Assoc · Phase 3 · completed

Other recruiting trials for Endometriosis

Currently open trials in the same condition.

NCT06559852 — The Impact of Yoga on Endometriosis-Related Pain · NA · recruiting
NCT07393295 — Efficacy and Tolerability of TENS in Endometriosis-related Pain · NA · recruiting
NCT07134023 — Educational Program for the Multidisciplinary Support of Patients With Endometriosis · NA · recruiting
NCT07240883 — ENDO1000 - A UK-wide Endometriosis Research Project · recruiting
NCT06974773 — Remote Electrical Stimulation as a Long-term Intervention for Endometriosis Flare Ups · NA · recruiting

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03343067 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 27 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03343067.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03343067

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of elagolix

Other recruiting trials for Endometriosis

Other AbbVie trials

Verify against primary sources