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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age0+
SponsorSumitomo Pharma Switzerland GmbH

About this trial

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 criteria

Qualifiers

Woman of any age

Currently or recently pregnant

Consent to participate

Authorization for her HCP(s) to provide data to the registry

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Relugolix-Containing Product

Treatment groups

728 Participants
are divided into 2 treatment groups

Locations

1
PPD28401, WilmingtonNorth Carolina, United States

Sponsors and collaborators

Sumitomo Pharma Switzerland GmbH

Lead sponsor