Relugolix Pregnancy Registry: Safety in Pregnant Women and Their Babies

This is an observational study, called the Relugolix Pregnancy Registry, looking at the safety of relugolix-containing medicines when taken during pregnancy. Researchers want to understand if there's a connection between taking relugolix and any health outcomes for the mother, fetus, or baby. You can join if you are a woman of any age who is currently or recently pregnant and agree to participate. The main goal is to see if relugolix is linked to major birth defects (major congenital malformation). This study is currently unclear on its recruitment status.

Study design
This is an observational study designed to enroll 728 women. There are two groups: those exposed to relugolix during pregnancy and those with a condition that might be treated with relugolix but who were not exposed.
What's involved
You would provide consent and authorize your healthcare providers to share your medical data with the registry. No additional tests or doctor visits are required beyond your usual medical care.
Compensation
Not stated in the trial record.
Follow-up
Your pregnancy outcomes will be assessed throughout pregnancy, and infant outcomes will be assessed for the first year of life. The primary outcome, major congenital malformation, will be measured for up to 10 years.

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NCT05739123

Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

Recruiting
Not specifiedAges 0+Observational
Sumitomo Pharma Switzerland GmbH
~728 participants
Updated 2025-08-19 on ClinicalTrials.gov
What's tested:Relugolix-Containing Product

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major Congenital Malformation (MCM)
Measured over Up to 10 years
Pregnancy Related
Pregnancy Complications
Pregnancy, High Risk
1 sites across 1 states
North Carolina1

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Eligibility criteria

Inclusion

Woman of any age
Currently or recently pregnant
Consent to participate
Authorization for her HCP(s) to provide data to the registry
Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy
Diagnosis of a condition for which relugolix-containing therapy may be prescribed and who are not exposed to relugolix containing therapy at any time during pregnancy

Exclusion

Occurrence of pregnancy outcome prior to first contact with the registry coordination center (retrospectively enrolled)
Exposure to known teratogens and/or investigational medications during pregnancy
Lost to follow-up
  • Major Congenital Malformation (MCM)Up to 10 years

    Comparison of rate of MCM between cohorts