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Pregnancy registry for elagolix users launched, then stopped early

NCT ID NCT04464187

Knowledge-focused Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This registry aimed to track pregnancy outcomes in women who were exposed to elagolix (brand names Orilissa and Oriahnn) for endometriosis or uterine fibroids. The study planned to enroll 584 pregnant women, half with elagolix exposure and half without, and follow them through pregnancy and one year after delivery. However, the study was terminated early with only 173 participants enrolled, so results may be limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this registry could provide important safety information about pregnancy outcomes after elagolix use, helping doctors and patients make informed decisions.
What could go wrong
The study was terminated early with only 173 enrolled out of a planned 584, which may limit the reliability and generalizability of the results. As an observational registry, it cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

173 people

The number who actually took part.

Started

Jan 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women with or without exposure to Orilissa for their endometriosis or other indications for prescribing of the medication.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants exposed to Elagolix: * Currently pregnant. * Documentation that the participant was exposed to elagolix-containing product from 14 days after last menstrual period (LMP) or at any time during pregnancy. * Consents to participate in the study. If the participant is a minor, consent will be obtained according to local regulations. Internal Comparator: * Currently pregnant with endometriosis, uterine fibroids, or other conditions based on approved indications and prescribing patterns of elagolix-containing product. * Documentation that the participant was not exposed to elagolix-containing product from 14 days after LMP or any time during pregnancy. * Consents to participate in the study. If the participant is a minor, consent will be obtained according to local regulations. Exclusion Criteria: -None.

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Conditions

The condition(s) this trial relates to.

endometriosis uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometriosis Uterine fibrioids

Contacts and locations

Locations

  • Iqvia /Id# 240918

    Durham, North Carolina, 27703-8426, United States

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