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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 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Elagolix
- DRUG Combined Oral Contraceptive
Study Locations (20)
Alabama
- Pinnacle Research Group /ID# 217062 — Anniston
- ACCEL Research Sites /ID# 218044 — Birmingham
- Alabama Clinical Therapeutics /ID# 217166 — Birmingham
- Alabama Clinical Therapeutics /ID# 222301 — Birmingham
- University of Alabama at Birmingham - Women's and Infant's Center /ID# 224503 — Birmingham
- Trinity Research Group /ID# 246932 — Dothan
- Southern Women's Specialists PC /ID# 217143 — Fairhope
- Women's Health Alliance of Mobile /ID# 222591 — Mobile
- Mobile, OBGYN P.C. /ID# 217135 — Mobile
California
- Diagnamics Inc. /ID# 225385 — Encinitas
- Atella Clinical Research /ID# 224024 — La Palma
- Valley Renal Medical Group Research /ID# 228614 — Northridge
- Futura Research, Org /ID# 217361 — Norwalk
- Northern California Research /ID# 217301 — Sacramento
- A & B Clinical Research /ID# 224471 — San Diego
- Advanced Clinical Research Center, LLC /ID# 248398 — San Diego
Arizona
- North Valley Women's Care /ID# 217092 — Glendale
- MomDoc Womens Health Research /ID# 221661 — Phoenix
Arkansas
- Applied Research Center of Arkansas /ID# 248494 — Little Rock
- Unity Health- Searcy Medical Center /ID# 217050 — Searcy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2020-08-10 |
| Est. Completion | 2030-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04333576
The ClinicalTrials.gov registry entry for NCT04333576 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Endometriosis appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04333576 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Alabama, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04333576 about?
NCT04333576 is a clinical study titled "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". 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 ...
What is the current status of trial NCT04333576?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 800 participants. The study started on 2020-08-10. Estimated completion is 2030-06.
What conditions does trial NCT04333576 study?
This clinical trial studies the following conditions: Endometriosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04333576?
The interventions under investigation include: Placebo (DRUG), Elagolix (DRUG), Combined Oral Contraceptive (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04333576?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04333576 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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