Pregnancy registry for elagolix users launched, then stopped early

NCT ID NCT04464187

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

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.

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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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