Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring
Recruiting now
Conditions studied: Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk
In brief
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.
Key facts
- Study ID
- NCT05739123
- Run by
- Sumitomo Pharma Switzerland GmbH
- People needed
- 728
- Starts
- 2023-05-08
- Expected to finish
- 2033-05-01
- Last updated by the study team
- 2025-08-19
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Woman of any age
- Currently or recently pregnant
- Consent to participate
- Authorization for her HCP(s) to provide data to the registry
- Cohort 1
- Exposure to at least one dose of relugolix-containing therapy at any time during pregnancy
- Cohort 2
- 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
You may not qualify if…
- The following will be eligible for enrollment, included in supplementary analyses, but excluded from the analysis population:
- 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
Where it is running
- PPD — Wilmington, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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