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

Launched by SUMITOMO PHARMA SWITZERLAND GMBH · Feb 13, 2023

Keywords

ClinConnect Summary

The Relugolix Pregnancy Registry is a study designed to learn more about the safety of using relugolix, a medication, during pregnancy. The researchers want to understand how this therapy might affect mothers, their unborn babies, and infants after birth. They will collect information from women who are currently pregnant or have recently given birth, as well as from the healthcare providers who care for them. This study is important for ensuring that the use of relugolix is safe for both mothers and their children.

To participate in this study, women of any age who are currently or recently pregnant can join, as long as they agree to share information about their health and their baby's health with the researchers. There are two groups in the study: one group includes women who have taken relugolix during pregnancy, and the other group includes women who have a condition that could require this therapy but have not taken it during pregnancy. Participants will be followed closely, and the study will help provide valuable insights into the effects of this medication during pregnancy. If you're considering joining or want more information, it's a good idea to talk to your healthcare provider.

Gender

FEMALE

Eligibility criteria

• 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