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NCT04333576 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Endometriosis, sponsored by AbbVie.
- Active
- Registry status
- Phase 3
- Development phase
- 800
- Enrollment target
- 20
- Study locations
NCT04333576: Active Phase 3 study of Endometriosis, sponsored by AbbVie.
NCT04333576 is a Phase 3 study of Endometriosis that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 800 participants, above the 248-participant average among 48 other Endometriosis trials with a reported enrollment target (223% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04333576, a Phase 3 study of Endometriosis, is active but no longer recruiting, sponsored by AbbVie.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 800 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
DYS response is measured by the 4-point Endometriosis Daily Pain Impact Scale (none, mild, moderate, severe) and with stable or decreased analgesic use.
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 |
What the registry record for NCT04333576 still lists
NCT04333576 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 248-participant average among 48 other Endometriosis trials with a reported enrollment target (223% higher).
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.
NCT04333576 names 20 study sites across 4 states, led by Alabama, California, Arizona.
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.
What interventions are being tested in trial NCT04333576?
The interventions under investigation include: Placebo (DRUG), Elagolix (DRUG), Combined Oral Contraceptive (DRUG).
Who is sponsoring clinical trial NCT04333576?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04333576's enrollment target sits among peer trials
800 7th of 48 higher than 42 of 48 other Endometriosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometriosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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