Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

NCT04333576 · tracked via the Priya Life Science USA tracker

Sponsor

AbbVie

Phase

Phase 3

Started

2020-08-10

Last updated

2026-06-12

Condition(s) studied

Endometriosis

Investigational drug(s) / intervention(s)

ElagolixPlaceboCombined Oral Contraceptive

Elagolix: Tablet:Oral

Placebo: Tablet:Oral

Combined Oral Contraceptive: Tablet:Oral

Study summary

Endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. Endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. This study will evaluate how well elagolix in combination with combined oral contraceptives (COC) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). This study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain.

Elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. Participants are randomly put in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 3 chance that participants will be assigned to placebo. Adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. Around 800 participants will be enrolled in the study at multiple sites in the United States, including Puerto Rico.

Participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (COC) or placebo capsules for 3 months. All the participants will receive elagolix tablets in combination with COC tablets from Month 4 through Month 18.

There will be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

49 Years

Healthy volunteers

Inclusion Criteria: * Documented surgical confirmation of endometriosis and associated moderate to severe pain. * Participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study. * Participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (COCs). Exclusion Criteria: * Pregnant or breastfeeding or planning a pregnancy until completion of the study. * Surgical history of hysterectomy or bilateral oophorectomy. * Participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from Screening. * Participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.

Primary outcome measure(s)

Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale — Month 3
DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.
Number of Participants Experiencing Adverse Events (AEs) — Up to approximately 50 months
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Trial sites (179)

Facility	City	Region
Pinnacle Research Group /ID# 217062	Anniston	Alabama
ACCEL Research Sites /ID# 218044	Birmingham	Alabama
Alabama Clinical Therapeutics /ID# 217166	Birmingham	Alabama
Alabama Clinical Therapeutics /ID# 222301	Birmingham	Alabama
University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503	Birmingham	Alabama
Trinity Research Group /ID# 246932	Dothan	Alabama
Southern Women's Specialists PC /ID# 217143	Fairhope	Alabama
Women's Health Alliance of Mobile /ID# 222591	Mobile	Alabama
Mobile, OBGYN P.C. /ID# 217135	Mobile	Alabama
North Valley Women's Care /ID# 217092	Glendale	Arizona
MomDoc Womens Health Research /ID# 221661	Phoenix	Arizona
Applied Research Center of Arkansas /ID# 248494	Little Rock	Arkansas
Unity Health- Searcy Medical Center /ID# 217050	Searcy	Arkansas
Diagnamics Inc. /ID# 225385	Encinitas	California
Atella Clinical Research /ID# 224024	La Palma	California
Valley Renal Medical Group Research /ID# 228614	Northridge	California
Futura Research, Org /ID# 217361	Norwalk	California
Northern California Research /ID# 217301	Sacramento	California
A & B Clinical Research /ID# 224471	San Diego	California
Advanced Clinical Research Center, LLC /ID# 248398	San Diego	California
Rocky Mountain Internal Medicine - Aurora /ID# 245161	Aurora	Colorado
Velocity Clinical Research - Denver /ID# 217297	Denver	Colorado
Boeson Research - Grand Junction /ID# 248580	Grand Junction	Colorado
Advanced Women's Health Institute /ID# 217150	Greenwood Village	Colorado
Red Rocks OB/GYN /ID# 217103	Lakewood	Colorado
Reproductive Assoc of Delaware /ID# 227764	Newark	Delaware
Medstar Health Research Institute /ID# 244937	Washington D.C.	District of Columbia
James A. Simon, MD, PC /ID# 218116	Washington D.C.	District of Columbia
Topaz Clinical Research /ID# 218615	Apopka	Florida
Ideal Clinical Research Inc. /ID# 218832	Aventura	Florida
Helix Biomedics, LLC /ID# 218649	Boynton Beach	Florida
Olympian Clinical Research /ID# 244426	Clearwater	Florida
Women's Medical Research Group /ID# 218524	Clearwater	Florida
Doral Medical Research, LLC /ID# 225146	Doral	Florida
Universal Axon Clinical Research /ID# 248553	Doral	Florida
KO Clinical Research, LLC /ID# 217173	Fort Lauderdale	Florida
Alliance for Multispecialty Research (AMR) - Fort Myers /ID# 217061	Fort Myers	Florida
Solutions Through Adv Rch /ID# 220973	Jacksonville	Florida
Care Partners Clinical Research /ID# 217042	Jacksonville	Florida
Vida Clinical Research /ID# 245325	Kissimmee	Florida

+ 139 more sites — see the full list on the official registry below.

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Other trials for the same condition

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Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck) Recruiting

Mitochondrial DNA Deletions in Plasma as a Diagnostic Aid for Females Presenting With Symptoms of Endometriosis Starting soon

Proof of Concept Study to Eval MetriDx Lab-developed Test to Identify Endometriosis-specific Bio Markers Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04333576 on ClinicalTrials.gov ↗ ← All trials in the USA