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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

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NCT04333576 · readout ≤ 346 d

Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
800estimated
Sites
179
Countries
Puerto Rico, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2020-08-10actualWhen the study began enrolling
Primary completionJul 2027estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionJul 2027estimatedThe whole study's end, after follow-up
First posted2020-04-03actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-06-12actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Endometriosis

Interventions

  • Drug: Elagolix — also filed as ABT-620, Orilissa
  • Drug: Placebo
  • Drug: Combined Oral Contraceptive

Primary outcomes

what the primary-completion date above is the date OF
Percentage of Responders Based on Dysmenorrhea (DYS) Pain Scale
measured Month 3
Number of Participants Experiencing Adverse Events (AEs)
measured Up to approximately 50 months

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