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

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

Inclusion Criteria:

* 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

Exclusion Criteria:

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

Conditions4

Locations1 site

Browse More Trials