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)
A Phase 3b Study to Evaluate the Safety and Efficacy of Elagolix in Combination With Combined Oral Contraceptives in Premenopausal Women With Documented Endometriosis and Associated Moderate to Severe Pain
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Pinnacle Research Group /ID# 217062 — Anniston, Alabama
Age range: 18 Years to 49 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (179 Sites)
Showing the first 25 of 179 sites.
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Endometriosis
- Nutritional Intervention for Endometriosis — Washington D.C., District of Columbia
- Evaluation of Endometriosis With 18F-fluorofuranylnorprogesterone PET / MRI — Chapel Hill, North Carolina
- The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA — Palo Alto, California
- Cancer Driving Mutations in Endometriosis Lesions and Development of Progesterone Resistance — New Haven, Connecticut
- Endometriosis and Health Care System Utilization in British Columbia — Vancouver, British Columbia
Explore by condition: All Endometriosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.