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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Endometriosis

In brief

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.

Key facts

Study ID

NCT04333576

Run by

AbbVie

People needed

800

Starts

2020-08-10

Expected to finish

2027-07-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 49. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• ACCEL Research Sites /ID# 218044 — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics /ID# 217166 — Birmingham, Alabama, United States
• Alabama Clinical Therapeutics /ID# 222301 — Birmingham, Alabama, United States
• University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503 — Birmingham, Alabama, United States
• Trinity Research Group /ID# 246932 — Dothan, Alabama, United States
• Southern Women's Specialists PC /ID# 217143 — Fairhope, Alabama, United States
• Women's Health Alliance of Mobile /ID# 222591 — Mobile, Alabama, United States
• Mobile, OBGYN P.C. /ID# 217135 — Mobile, Alabama, United States
• North Valley Women's Care /ID# 217092 — Glendale, Arizona, United States
• MomDoc Womens Health Research /ID# 221661 — Phoenix, Arizona, United States
• Applied Research Center of Arkansas /ID# 248494 — Little Rock, Arkansas, United States
• Unity Health- Searcy Medical Center /ID# 217050 — Searcy, Arkansas, United States
• Diagnamics Inc. /ID# 225385 — Encinitas, California, United States
• Atella Clinical Research /ID# 224024 — La Palma, California, United States
• Valley Renal Medical Group Research /ID# 228614 — Northridge, California, United States
• Futura Research, Org /ID# 217361 — Norwalk, California, United States
• Northern California Research /ID# 217301 — Sacramento, California, United States
• A & B Clinical Research /ID# 224471 — San Diego, California, United States
• Advanced Clinical Research Center, LLC /ID# 248398 — San Diego, California, United States
• Rocky Mountain Internal Medicine - Aurora /ID# 245161 — Aurora, Colorado, United States
• Velocity Clinical Research - Denver /ID# 217297 — Denver, Colorado, United States
• Boeson Research - Grand Junction /ID# 248580 — Grand Junction, Colorado, United States
• Advanced Women's Health Institute /ID# 217150 — Greenwood Village, Colorado, United States
• Red Rocks OB/GYN /ID# 217103 — Lakewood, Colorado, United States
• Pinnacle Research Group /ID# 217062 — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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