RecruitingNCT05739123

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


Sponsor

Sumitomo Pharma Switzerland GmbH

Enrollment

728 participants

Start Date

May 8, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.


Eligibility

Sex: FEMALEMin Age: 0 Years

Plain Language Summary

Simplified for easier understanding

This study is a pregnancy registry — not a treatment trial — that tracks the health outcomes of pregnant women who were exposed to relugolix (a hormone therapy used for conditions like uterine fibroids or prostate cancer) during pregnancy, and their babies. The goal is to understand whether this medication poses any risks during pregnancy. **You may be eligible if...** - You are a woman of any age who is currently or was recently pregnant - You were exposed to at least one dose of a relugolix-containing medication at any point during your pregnancy (Cohort 1), OR - You have a condition for which relugolix may be prescribed but you did not take it during pregnancy (Cohort 2) - You consent to having your healthcare provider share data with the registry **You may NOT be eligible if...** - Your pregnancy outcome already happened before you first contacted the study - You were exposed to medications known to cause birth defects during the pregnancy - You are lost to follow-up and cannot be contacted for updates Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRelugolix-Containing Product

Any relugolix-containing therapy


Locations(1)

PPD

Wilmington, North Carolina, United States

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NCT05739123


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