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Evaluating Elagolix with Birth Control for Pain from Endometriosis

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

Phase 3 Interventional AbbVie · NCT04333576

This study is testing whether taking elagolix tablets with birth control can help women with endometriosis feel less pain and improve their quality of life.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment800 (estimated)
Ages18 Years to 49 Years
SexFemale
SponsorAbbVie Industry-sponsored
Locations179 sites (Anniston, Alabama and 178 other locations)
Trial IDNCT04333576 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the effectiveness and safety of elagolix tablets combined with oral contraceptives in treating dysmenorrhea in adult women diagnosed with endometriosis. Participants will be randomly assigned to one of three groups, including a placebo group, to evaluate their response to treatment over a three-month period. The study aims to enroll around 800 women who experience moderate to severe pain due to endometriosis, with a focus on improving their quality of life. The trial will take place across multiple sites in Alabama.

Who should consider this trial

Good fit: Ideal candidates are adult females with documented endometriosis and moderate to severe dysmenorrhea who are not pregnant or breastfeeding.

Not a fit: Patients who have undergone a hysterectomy or bilateral oophorectomy, or those with other chronic pain conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce menstrual pain and improve the quality of life for women suffering from endometriosis.

How similar studies have performed: Previous studies have shown positive outcomes with elagolix for endometriosis-related pain, indicating a promising approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Anniston, Alabama and 178 other locations

+129 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions EndometriosisElagolixCombined oral contraceptivesOrilissaDysmenorrhea
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.